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KENNETH T. KIM, M.D. ____________________ BUSINESS ADDRESS: 2600 Redondo Ave, Suite 400 & 401 Long Beach, CA 90806 Tel (562) 997-7888 Tel (562) 997-8884 3545 Howard Way Costa Mesa, CA 92626 Tel (714) 460-8858 Fax (714) 556-3139 PROFESSIONAL AFFILIATIONS: Founder, President, CEO and Medical Director, West Coast Clinical Trials, LLC, 1998- present Medical Director, Allergy, Asthma, & Respiratory Care Medical Center, Inc., 1996-present Founder and President of FLARE, Foundation for Learning about Asthma, Allergy, & Respiratory Education, a nonprofit foundation, 1996-present LOCAL PROFESSIONAL APPOINTMENTS: Chairman, Department of Medicine, Long Beach Memorial Medical Center, 1998-2000. Vice Chairman, Department of Medicine, Long Beach Memorial Medical Center, 1996-1998. Chairman, Latex Allergy Committee, Long Beach Memorial Medical Center, 1995-present. Member, The Los Angeles Task Force for The Africanized Honey Bee, 1994- 2000 Member, Los Angeles Society of Allergy, 1994-2002 Member, Orange County Society of Allergy, 2002-present FACULTY APPOINTMENTS: UCLA School of Medicine, Los Angeles, CA Assistant Clinical Professor, 11/93- present Clinical Instructor, 7/89-10/91 UCI School of Medicine, Irvine, CA Assistant Clinical Professor, 7/94-present Harvard University, Cambridge, MA Teaching Fellow for Biochemistry 10a, 1979-1986 Assistant Senior Tutor, Quincy House, 1985-1986 EDUCATION: Wadsworth VA Hospital Los Angeles, CA Allergy and Immunology Fellowship, 10/91-10/93 Version 08/22/2005 1 UCLA Center for the Health Sciences Los Angeles, CA Internal Medicine Residency, 7/87-6/89 New York Hospital, New York, NY Internal Medicine Internship, 7/86-6/87 Massachusetts Institute of Technology, Cambridge, MA Kaiser Scholar of Health Policy, 9/84-1/86 Harvard Medical School, Boston, MA Medical Doctorate, 1986 Harvard College, Cambridge, MA A.B., Biochemical Sciences, 1981 summa cum laude Phi Beta Kappa PRACTICE HISTORY: Private Practice, Newport Beach, CA, 2002-present Private Practice, Long Beach, CA, 1996-present Memorial Medical Group, Staff Allergist, Long Beach, CA, 1993-1996 Private Practice, Van Nuys, CA, 1989-1991 CERTIFICATION: Recertified, American Board of Allergy and Immunology, 2003 Diplomate American Board of Allergy and Immunology, 1993 Diplomate American Board of Internal Medicine, 1989 Fellow, American Academy of Allergy, Asthma, & Immunology, 1998 Fellow, American College of Allergy, Asthma, & Immunology 1994 California License No G-61259, 1987-present Medical expert reviewer panel, Medical Board of California, 1996-present EDITORIAL BOARDS: Western Journal of Medicine, 1999-present Annals of Allergy, Asthma, & Immunology, 1999-present Version 08/22/2005 2 HOSPITAL AFFILIATIONS: Long Beach Memorial Hospital Los Alamitos Hospital Fountain Valley Regional Hospital and Medical Center Hoag Hospital Community Hospital of Long Beach PUBLIC SERVICE: Peninsula Education Foundation Board Member, Palos Verdes, 1997-1999 Goodwill Industries, Board Member, 1993-1994 Korean Health Education Information Referral Center Board Member, 1991-1993 Board of Directors, Asthma and Allergy Foundation, 1993-2003 Program Manager, The Children’s Asthma Consortium, CDC 5 year contract for providing Asthma Education for Children 4-11, (one of 24 sites), 2001-2006 NATIONAL COMMITTEE APPOINTMENTS: ACAAI’s Latex Allergy Committee, member 1993-2000 ACAAI’s Latex Allergy Committee, Vice Chair, 1998-1999 ACAAI’s Latex Allergy Committee, Chairman, 2000-2001 ACAAI’s Insect Hypersensitivity Committee, member 1997-1998 ACAAI’s Allied Health Professionals Committee, member 1996-1999 ACAAI’s Allied Health Professionals Committee, Co-Chairman 1997-1999 ACAAI’s Allied Health Subcommittee for Office Managers for 1997-1998 ACAAI’s Occupational Health Committee, member 1996-1998 ACAAI’s Occupational Committee Co-Chair, 1998-2000 ACAAI’s Managed Care Committee, member 1996-1998 MEDICAL LEGAL CONSULTING: 1. 2. 3. 4. 5. 6. 7. Mold allergy civil litigation and workers compensation claims. Latex product liability cases Latex disability insurance claims Medical malpractice case reviews Medical Board of California standard of care cases Workers’ compensation cases Civil litigation cases on toxic exposures, sick building, allergic reactions, smoke inhalation, multiple chemical sensitivities, asthma, and lung diseases. Version 08/22/2005 3 MEDIA Interview on ABC “Pediatric asthma” 8/26/00 Interview on CNN “Pediatric asthma” 10/19/00 Interview on NBC Nightly News “Cure for the common cold” 3/26/01 Interview on KSCI 18 "LA SEOUL", "Pediatric Asthma" 06/09/01 NATIONAL SPEAKING: American Academy of Allergy and Immunology, New York, NY 2/26-27/95, Basic Rhinolaryngoscopy workshop. American College of Allergy and Immunology, Dallas, TX, 11/13-14/95 1) Basic Rhinolaryngoscopy workshop. 2) Latex Allergy, Meet the Professor session American Academy of Allergy and Immunology, New Orleans, LA 3/15-20/96: Basic Rhinolaryngoscopy Foundation for Latex Allergy Research and Education (FLARE),Western Regional Latex Allergy Conference, October 12, 1996, Conference Director, also lectured on "Diagnostic Issues and Management of Latex Allergy" American College of Allergy and Immunology, Boston, MA 11/8-11/12/96 1) Bronchial Challenge in the Office setting (workshop), a presentation of latex bronchial challenges. 2) Latex Allergy: Two breakfast seminars for the Allied Health course.American Academy of Allergy and Immunology, San Francisco, CA 2/25/97:"Diagnostic Evaluation of Type I Latex Allergy" American College of Allergy, San Diego, CA; 11/9/97, Latex Allergy, Allied Health plenary, interactive panel. “Diagnostic Evaluation of Type I Latex Allergy Association of Occupational Health Professional 17th Annual meeting, Nov. 15, 1997 Garden Grove, CA “Latex Allergy”, October 24, 1997, Garden Grove, CA. Association of Occupational Health Professionals National Conference, "Occupational Latex Allergy: How to protect our patients and ourselves", October 23, 1997; Garden Grove, CA. “Nursing Issues in Ambulatory Pediatrics, Birth through Adolescence”, National Conference for National Association Pediatric Nurse Practitioners, Two Invited Lectures: “Asthma Update: Whole Lot of Wheezing Going On” and “Latex Allergy: More Dangerous Than You Think”: Saturday, October 25, 1997, Anaheim, CA Association of Occupational Health Professionals, “Occupational Management of Latex Allergy”, October 22, 1998, Orlando, FL. American College of Allergy, Philadelphia, PA, “Latex Allergy Workshop for Allied Health” November 8, 1998 Association of Operating Room Nurses, “Latex Allergy: Latest Insights on Diagnosis and Management”, March 29, 1999, San Francisco, CA. American College of Allergy, Asthma, & Immunology, Chicago, Il, November 1999, “Latex Allergy”; Meet the Professor Session. Version 08/22/2005 4 American Academy of Allergy and Immunology, San Diego, CA 3/05/00 Basic Rhinolaryngoscopy Workshop. American College of Allergy and Immunology, Seattle, WA 11/4/00 Latex Allergy workshop: Latex Allergy Management, Meet The Professor Session. California Society of Allergy, Asthma, & Immunology, “Latex Allergy in the Workplace.” Squaw Creek, CA 10/10/01. American Academy of Nurse Practitioners, “Allergies in the Workplace,” July 1, 2001, Orlando Fl. American Academy of Nurse Practitioners, “Food Allergy: When does it Really Occur,” July 1, 2001, Orlando FL. American College of Allergy, Allied Health. "Latex Allergy" workshop, 11/17/2001 and "Allergic Rhinitis: New Insights" interactive panel, 11/18/2001 PUBLICATIONS: Kim, K., Apirion, D., and Ghora, B.: Small stable RNA of Neurospora crassa. Molecular and General Genetics 160:25-32, (1980). Patsch W., Kim, K., Wiest, W., and Schonfeld, G.: Effects of Sex Hormones on Rat Lipoproteins. Endocrinology 107 (4): 1085-94, (1980). Contributing author to the President's Commission for the Study of Ethical Problems in Medicine reports, "Splicing Life" (1982) and "Deciding to Forego Life-Sustaining Treatment" (1983). Black, K., Hawkin, R., Kim, K., Becker, D., Lerner, C., and Marciano, D. Use of Thallium-201 SPECT to Quantitative Malignancy Grade of Gliomas. Journal of Neurosurgery 71:342-46, (1989). Kim, K., Black, K., Marciano, D., Mazziota, J., Guze, B., Grafton, S., Hawkings, R., Becker, D. Thallium-201 SPECT Imaging of Brain Tumors: Methods and Results. Journal of Nuclear Medicine, 31:965-969, (1990). Kim, K., Kwong, F., and Klaustermeyer, W. Use of OTC Afrin to Abort Anaphylaxis. Lancet, 341: 439, 1993. Kim, K., Kuhn, G., et Klaustermeyer, W. Chondrosarcoma presenting as asthma exacerbation Annals of Allergy, 72, 14-17, 1994. Kim, K. The Africanized Honey Bee: A Belated Arrival to California, New England Journal of Medicine, 331, 1776, 1994. Charous, B.L., Banov, C., Bardana, E., Blaiss, M., Hamilton, R, Kim, K., et. al.Latex allergy--an emerging healthcare problem. American College of Allergy, Asthma and Immunology position statement, Annals of Allergy, 75, 19-21, 1995. Kim, K. New Latex Allergy Policy Adopted, SCOPE, October 1995. Version 08/22/2005 5 Kim, K., Metcalfe, J., Sheikh, K., Miller, J., Edwards, R., Cown, S., Altadeff, G., Li, W. Recommendations for Hospital Risk Management of Latex Allergy, presented FLARE conference 10/12/96. Kim, K. "Latex Allergy" American Academy of Family Physicians Home study audiotape series, volume 214, March 1997. Kim, Kenneth T., “Latex Allergy-The Latest Insights”, WJM, November 1997, Volume 167, No. 5. Kim, K., Safadi G., Sheikh, K. Diagnostic Evaluation of Type I Latex Allergy, Annals of Allergy, volume 80, January 1998, p 66. Kim, K., Graves, P., Safadi, G., Alhadeff, G., Metcalfe, J. Implementation Recommendations for Making Health Care Facilities Latex Safe, AORN Journal, 67, March 1998, pp. 615-632. Lee, M. Kim, K. Latex Allergy: A Relevant Issue in the General Pediatric Population, Journal of Pediatric Health Care, (1998), 12, 242-246. Hamilton, R., Adkinson, F., and the Multi-center Latex Skin Testing Study Task Force (Kenneth T. Kim, MD is part of the Multi-center Latex Skin Testing Study Task Force). Diagnosis of natural rubber latex allergy: Multi-center latex skin testing efficacy study, Journal of Allergy and Clinical Immunology, 102, 482-90, 1998. Hamilton, R., Adkinson, F., and the Multi-center Latex Skin Testing Study Task Force (Dr. Kenneth T. Kim, MD is part of the Multi-center Latex Skin Testing Study Task Force). Diagnostic Performance of FDA- Cleared Serological Assays for Natural Rubber Latex-Specific IgE Antibody, Journal of Allergy and Clinical Immunology, Vol.80, No.1, 671-677,1999. Kim, K. and Hussain, H., Prevalence of Food Allergy in 137 Latex Allergic Patients, Allergy and Asthma Proceedings, Vol.20, No.4, p.95-97, March-April 1999. Kim, K. and Safadi, G.S., Relation of latex-specific IgE titer and symptoms in patients allergic to latex, Journal of Allergy and Clinical Immunology, Vol. 103, No. 4, April 1999 Kim, K, and Oguro, J., Update on the Status of Africanized Honey Bees in the Western States, Western Journal of Medicine, Vol. 170, No.4, April 1999 Kim, K, Wellmeyer, E, and Miller, K., Minimum Prevalence of latex hypersensitivity in health care workers”, Allergy and Asthma Proceedings, vol.20, No.6, November-December 1999. Kim, K., Ginchansky, E., Friedman, B., Srebro, S., Pepsin, P., Edward, L., Standford, R. and Rickard, K., Fluticasone Propionate Versus Zafirlukast: Effect in Patients Previously Receiving Inhaled Corticosteriod Therapy, Annals of Allergy, Asthma, & Immunology, Vol. 85, No. 5, 398406, November 2000. Version 08/22/2005 6 Milgrom H, Skoner DP, Bensch G, Kim KT, Claus R, Baumgartner RA, Low Dose Levalbuterol in Children with Asthma: Safety and Efficacy Compared With Placebo and Racemic Albuterol, Journal of Allergy and Immunology, Vol. 108, No. 6, 108:938-45, Dec. 2001. N.N.Kim, K.Y. Yoon, K.T. Kim, Sensitivity of Exhaled Nitrous Oxide In Detecting Airway Inflammation, Annals Of Allergy Asthma & Immunology, Jan 2005, 94(1)146:P87 Kenneth T. Kim, MD, Edwark Kerwin, MD, Lawrence Landwehr, MD, Jonathan A. Bernstein, MD, Dawn Bruner, MD, Duane Harris, MD, Kristin Drda, PharmD, Jack Wanger, MS, and Chester C. Wood, MD Use of 0.06% ipratropium bromide nasal spray in children aged 2 to 5 years with rhinorrhea due to a common cold or allergies, Annals of Allergy Asthma & Immunology, Vol. 94, (1) January 2005 Kim KT, Rabinovitch N, Uryniak T, Simpson B, O’Dowd L, Casty F, Effect of budesonide aqueous nasal spray on hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis, Annals of Allergy, Asthma & Immunology, 2004-Jul;93(1):67-7 ABSTRACTS: Kim, K., Dalton, J., and Klaustermeyer, W. Hypersensitivity Pneumonitis to Feathers: A Case Report, Annals of Allergy 70: 90, 1993. Kim, K., Kuhn, G, and Klaustermeyer, W. Chondrosarcoma Presenting as Asthma Exacerbation, Annals of Allergy 71, 173, 1993. Kim, K., Li, Wei-guo. Prevalence of Latex Allergy in Health Care Workers. Long Beach Memorial research symposium, November 17, 1995. Kim, K. Latex Allergy in Health care workers. World Congress of Korean Physicians, December 1995 meeting. Lee K, Klaustermeyer W, Kim K. Disseminated Gonococcal Infection and Strongyloides stercolis infection associated with C5 deficiency, Annals of Allergy, presented at American College of Allergy 1996 meeting. Smith, C, Garcia M, Kim K. Latex Exposure Causing Ulcerative Dermatitis, Journal of Allergy and Clinical Immunology, 99, 1 (1997), # 1405. Lee KG, Klaustermeyer WB, Kim KT. Latex Provocation Challenge and Latex Allergy, Journal of Allergy and Clinical Immunology 99,1, (1997), #648. Kim, K, Sheikh, K. Diagnostic Evaluation of Type I Latex Allergy, Journal of Allergy and Clinical Immunology, 99, 1, (1997), # 2005. Williams, PB, Ownby D, Kim KT, Magera B. Comparing Two Methods for Assessing Specific IgE to Latex, European Academy Allergology, and Clinical Immunology 1997 meeting abstract. Version 08/22/2005 7 Tsai, P.B., Oh, C.K., Robinson, L.D., and Kim, K.T., Latex Prick Testing with Glove versus Raw Latex Extract. Annals of Allergy, volume 80, January 1998, p 93,57 Miller KV, Altadeff G, Sheikh K, Kim KT. Prevalence of latex hypersensitivity in health care workers, Annals of Allergy, volume 80, January 1998,p101, P6. Miller, K., Kim, K.T., Minimum Prevalence of Latex Allergy In Health Care Workers, Annals of Allergy, volume 80, January 1998, p101, P6. Oda, K.K., Tsai, P.B., and Kim, K.T., Latex-Induced Anaphylaxis Precipitated by Indirect Contact, Annals of Allergy, volume 80, January 1998, p 101, P7. Naran, N., and Kim, K.T., Long Standing Food Allergies Preceding Clinically Apparent Latex Allergy, Annals of Allergy, volume 80, January 1998, p 95, 67 Tsai, P., Oh, C., Robinson, L., Kim, K., AlaSTAT vs. CAP Class for Predicting Latex-Related Symptoms in Patients Who Are RAST or Prick Positive to Latex, Journal of Allergy and Clinical Immunology, 101,1, (1998), #848. Hussain, H., Beall, G., Kim, K., Prevalence of Food Allergy In Patients With Latex Allergy, Journal of Allergy and Clinical Immunology, 101, 1, (1998), #860. Kim, K., Hussain, H., Beall, G., Latex Allergy And IgE Antibodies To Foods, Journal of Allergy and Clinical Immunology, 101,1, (1998), #859. Hamilton, RG, Adkinson, NF, Bdak, ME, Golden, DBK, Stadtmauer, GJ, Graft, DF, Kim, KT, Slater JE, MacLean, JA, Husman, DW. Multicenter Latex Skin Testing Study, Journal of Allergy and Clinical Immunology, 101,1,(1998), #682. Yu, F.C. and Kim, K.T., Case Report of a Latex Allergic Physician who Tolerated Biogel Gloves, Annals of Allergy, Asthma, & Immunology 84, No.1, January 2000. Kim, J., Miller, S. and Kim, K., Occupational Management of the Type I Latex Allergic Patient, The Journal of Allergy and Clinical Immunology, 105, No. 1, January 2000. Kim, K., Blatter, M., Hayden, FG. and Coats, T., Pleconaril Treatment for Viral Respiratory Illness in Adults, Annals of Allergy, Asthma and Immunology, 2001; 86: 86. Porch-Curren, C. and Kim, K., Longitudinal follow up of Latex-Specific IgE titers in Health Care Workers, Journal of Allergy and Clinical Immunology 2001, 107, No. 1, S128. Hayden FG, Kim K, Hudson S. Pleconaril treatment reduces duration and severity of viral respiratory infection (common cold) due to picornaviruses. 41st Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL. December 2001 (abstract H-659) Version 08/22/2005 8 Chiang, D., Kim K., Prevalence of Arabic and Karaya Gum Allergy in Latex-Allergic patients, Journal of Allergy and Clinical Immunology 2002,109. No 1, S333. Skoner DP, Kim KT, Greos L, Levalbuterol in 2-5 Year Old Children with Asthma: Results of a Large Clinical Trial Annals of Allergy , Asthma, and Immunology 2003;90:127 Chipps, B., Kim, K., Korenblat, P., Deniz, Y., Zheng, B., Carroll, A., Effect of Omalizumab on Health Care Utilization in Patients with Moderate to Moderate to Severe Allergic Asthma. Journal of Allergy & Clinical Immunology Feb 2003, 111, No 2, #301 Hayden, F.G., Belshe, R., Delfin, E., Kim, K., Lanno, R., Hughes, C., Small, I., Dutkowski, R., Ward, P., Carr, J., Management of influenza in households: a prospective, randomized comparison of oseltamivir treatment with or without post-exposure prophylaxis Hayden, F.G., Kim, K., Hudson, S., Villano, S.A., & The Pleconaril Respiratory Infection Study Group, Pleconaril Treatment Provides Early Reduction of Symptoms Severity in Viral Respiratory Infection (VRI) Due to Picornaviruses. 39th Annual Meeting of the Infectious Diseases Society of America, San Francisco, CA. 2001; 414 Hayden, F.G., Coats, T., Kim, K., Hassman, H.A., Blatter, M.M., Zhang, B., Liu, S., Oral pleconaril treatment of picornavirus-associated viral respiratory illness in adults: efficacy and tolerability in Phase II clinical trials, Antiviral Therapy,; Vol. 7 No. 1, 53-65 March 2002 Kim, K., Uryniak, T., Simpson, B., O’Dowd, L., Casty, F., Once-Daily Budesonide Aqueous Nasal Spray (BANS) Does Not Suppress Hypothalamic-Pituitary-Adrenal (HPA) Axis Function in Children 2 to 5 Years of Age With Allergic Rhinitis Journal of Allergy & Clinical Immunology Feb 2003, 111, No 2, #37 Wasserman, RL, Kim, KT, Blake, KV, Herje, NG, Scott, CA, Wu, W, Crim, CC, Barnhart, FH, Reisner, CC, “Fluticasone Propionate is Safe in Treating Pre-School Age Children (24-47 Months) with Asthma, Journal of Allergy & Clinical Immunology, Feb 2003, 111, No 2 #601 Kim, KT, Sussman, GL, Hebert, J, Lumry, WR, Lutsky, B, Gates, D, Effect of Once Daily Desloratadine in Patients with Perennial Allergic Rhinitis:, A Doulble Blind, Placebo Controlled Study. Journal of Allergy and Clinical Immunology Feb 2003, 111, No 2, #25 Chipps, B., Kim, K., Korenblat, P., Deniz, Y., Carroll, A., Effect of Omalizumab on Healthcare Utilization in Patients with Moderate to Severe Allergic Asthma. Journal of Allergy & Clinical Immunology Feb 2003, 111, No 2, #301 Yoon, K., Halsey, JF., Kim, KT., Antigenic Latex Protein From rubber bands. Journal of Allergy & Clinical Immunology, Feb 2004, 113, No 2, #208 Busse, WW., Baker, JW., Chaurous, BL., Chervinsky, P., Kim, KT., Gross, GN., Korenblat, PE., Shames, RS., Preliminary Safety and Efficacy of Daclizumab in the Treatment of Patients With Version 08/22/2005 9 Moderate to Severe Chronic Persistent Asthma. Journal of Allergy & Clinical Immunology, Feb 2004, 113, No 2, #1043 Kim, K., Uryniak, T., Simpson, B., O’Dowd, L., Casty, F., Once-Daily Budesonide Aqueous Nasal Spray (BANS) Does Note Suppress Hypothalmic-Pituitary-Adrenal (HPA) Axis Function in Children 2 to 5 Years of Age With Allergic Rhinitis. Annals of Allergy, Asthma & Clinical Immunology Jul 2004, 93(1):61-7 Busse WW, Baker JW, Lisberg EE, Charous BL, Chervinsky P, Kim KT, Gross GN, Korenblat PE, Shames RS., Preliminary Safety And Efficacy Of Daclizumab In The Treatment Of Patients With Moderate To Severe Chronic Persistent Asthma. Journal of Allergy & Clinical Immunology (Submitted) Safety and Efficacy of Ipratropium Bromide Nasal Spray 0.06% in Children 2 to 5 Years of Age with Rhinorrhea Associated with a Common Cold or Allergy. Annals of Allergy, Asthma & Clinical Immunology Jan 2005, 94(1):73-79 Nelson HS, Busse WW, Israel E, Baker JW, Charous BL, Kim KT, Gross GN, Corren J, Young D, Shames RS., Daclizumab Improves Asthma Control in Patients with Refractory Asthma. Journal of Allergy & Clinical Immunology , Feb 2005, 115(2), S302 #534 H.P. Spyers-Duran, T. T. Kim, Psychogenic reaction to Xolair. Abstract Book ACAAI Boston Annual Scientific Meeting, The Hynes Convention Center November 12-17, 2004, P71 (pg.42) N.N. Kim, K.Y. Yoon, K.T. Kim, Sensitivity of exhaled nitrous oxide in detecting airway inflammation. Abstract Book ACAAI Boston Annual Scientific Meeting, The Hynes Convention Center November 12-17, 2004, P87 (pg. 46 K.T. Kim, E.M. Kerwin, L. Landwehr, J. Wanger, P. Johnson, C.C. Wood, K. Drda, Safety and efficacy of ipratropium bromide nasal spray 0.06% in children 2 to 5 years of age with rhinorrhea associated with a common cold or allergy. Abstract Book ACAAI Boston Annual Scientific Meeting, The Hynes Convention Center November 12-17, 2004 P181 (pg.72) K.T. Kim, E.M. Kerwin, L. Landwehr, J. Wanger, P. Johnson, C.C. Wood, K. Drda, Safety and efficacy of Ipratropium Bromide Nasal Spray 0.06% in children 2 to 5 years of age with rhinorrhea associated with a common cold or allergy, Anals of Allergy, Asthma & Immunology,Vol. 94 (1)176:P181 January 2005 Hayden FG, Belshe R, Villanueva C, Lanno R, Hughes C, Small I, Dutowski R, Ward P, Carr J, Management of influenza in households: a prospective, randomized comparison of oseltamivir treatment with or without postexposure prophylaxis, J Infect Dis. 2004 Feb 1; 189(3):440-9. Epub 2004 Jan 26 Version 08/22/2005 10 REGULAR LECTURE/TEACHING PROGRAMS 1. Wadsworth VA Hospital allergy program 2. UCLA Harbor allergy program 3. UCI Memorial Hospital family practice program 4. UCI Memorial Hospital internal medicine program 5. UCI Memorial Hospital pediatric program 6. St. Mary's Medical center UCLA internal medicine program RESEARCH PROJECTS: 1. 1992 Sub-investigator and coordinator of an evaluation of a third generation antibiotics compared in patients with acute bronchitis. 2. 1992 Sub-investigator and coordinator, a multi-center comparative double blind study of two third generation antibiotics in adults with acute bacterial sinusitis. 3. 1993 Sub-investigator and coordinator, of a multi-center double blind randomized study of salmon calcitonin nasal spray in steroid induced osteoporosis. 4. 1993 Sub-investigator and coordinator, of a comparative study of oral antibiotic vs. a second generation antibiotic in acute bacterial exacerbation of chronic bronchitis in adults. 5. 1993 Sub-investigator and coordinator, of a multi-center study of two nasal corticosteroids in patients with perennial allergic rhinitis. 6. 1994-95 Principal Investigator, of a study of latex allergy in health care workers. 7. 1995-96 Principal Investigator, of a study of diagnostic tests for type I latex allergy. 8. 1997 Co-investigator of a multi-center phase III study to document the performance of the prototype NAL (non-ammoniated latex ) as a diagnostic skin testing material. Funding sources: Greer. Central coordinating site: Johns Hopkins University. 9. 1997-98 Principal Investigator of a study evaluating the role of latex specific IgE titers in predicting severity of symptoms. 10. 1997-02 Sub-investigator in a phase IV five year study of the effect of early intervention with long-term inhaled steroid in newly diagnosed asthma. 11. 1997-98 Principal Investigator in a comparative phase IV study of inhaled steroid vs. leukotriene in asthmatic subjects who are currently receiving low dose inhaled corticosteroids. Version 08/22/2005 11 12. 1998 Principal Investigator in once a day phase IV inhaled steroid versus BID inhaled steroid in mild to moderate asthma. 13. 1998 Principal investigator if a phase IIIb study of a randomized, parallel-group, openlabel, multicenter clinical study comparing the safety, efficacy, quality of life and socioeconomic variables of twice daily a long-acting β-2 agonist powder (12 ug bid) to twice daily long-acting β-2 agonist (50 ug bid) administered for six months to adult subjects with reversible obstructive airway disease . 14. 1998 Principal Investigator of phase III comparative safety and efficacy of third generation class of β-lactam antibioticscephalosporin and an antibiotic in the treatment of patients with acute bacterial sinusitis. 15. 1998 Principal Investigator of a phase III study evaluating an investigational oral anti-viral medication for the common cold. 16. 1998 Principal Investigator of a phase III study evaluating the safety and efficacy of HFA and CFC formulation of an inhaled steroid in pediatric patients with mild to moderate asthma. 17. 1998 Principal Investigator of a phase III study evaluating the safety and efficacy of inhaled steroid and long acting beta agonist individually and in combination administered to subjects with COPD. 18. 1998 Principal Investigator of a phase IV comparative study between a inhaled steroid powder and leukotriene antagonist in non-steroid dependent patients with asthma. 19. 1998 Principal Investigator of a phase IV comparative study of an inhaled steroid versus placebo via metered-dose inhaler in adolescent and adult oral corticosteroid-dependent asthmatics. 20. 1998 Principal Investigator of a phase III randomized study between two long acting beta agonists in moderate to severe asthmatic subjects. 21. 1999 Principal Investigator of a phase III study evaluating the combination of inhaled steroid/long-acting beta agonist in patients with moderate-severe asthma. 22. 1999 Principal Investigator of a phase III study comparing the safety and efficacy of a short acting beta agonist using two different delivery devices. 23. 1999 Principal Investigator of a phase IV study evaluating quality of life of patients taking a certain antihistamine. 24. 1999 Principal Investigator of a phase III study of an investigational antihistamine in patients with seasonal allergic rhinitis. Version 08/22/2005 12 25. 1999 Principal Investigator of a phase III comparative study evaluating the safety and efficacy of two different dosages of an inhaled steroid through an HFA device in pediatric patients with asthma. 26. 1999 Principal Investigator of a phase III study comparing the safety and efficacy of an investigational inhaled steroid in dry powdered inhaler form to one already on the market in patients with stable, moderate asthma. 27. 1999 Principal Investigator of a phase III study evaluating the safety of an investigational antihistamine in patients with perennial or seasonal allergic rhinitis. 28. 1999 Principal Investigator of a phase IIB study evaluating an antiviral tablet for the treatment of the common cold. 29. 1999 Principal Investigator of a phase IIIB study evaluating the efficacy and safety of an investigational inhaled steroid in dry powder form and a leukotriene modifier in subjects with asthma. 30. 1999 Principal Investigator of a phase III, open label taste evaluation of a rapidly disintegrating antihistamine tablet. 31. 1999 Principal Investigator of a phase II double-blind, placebo controlled study of an antiviral nasal spray for the treatment of the common cold. 32. 1999-00 Principal Investigator of a phase III study assessing the effect of an inhaled steroid on growth in pediatric patients with asthma. 33. 1999-00 Principal Investigator of a phase IV study comparing the efficacy of an inhaled steroid/long acting beta-agonist combination product vs. a leukotriene modifier in adults with persistent asthma. 34. 1999-00 Principal Investigator of a phase II study evaluating the safety and efficacy of an oral antibiotic for the treatment of acute maxillary sinusitis. 35. 1999-00 Principal Investigator of a phase IV study evaluating the effect of adding either an oral leukotriene modifier or a long acting beta-agonist to inhaled steroid treatment in adult asthmatics. 36. 1999-00 Principal Investigator of a phase III open label study evaluating the durability of a new delivery device. 37. 2000 Principal Investigator of a phase III study evaluating a steroid/beta agonist inhaler combination product in preventing exercise-induced bronchospasms. Version 08/22/2005 13 38. 2000 Principal Investigator of a phase III open label taste evaluation of a rapidly disintegrating antihistamine tablet in children. 39. 2000 Principal Investigator of a phase II double blind, placebo controlled study evaluating the efficacy of an oral muscarininic receptor antagonist in COPD. 40. 2000 Principal Investigator of a phase III study of a new antihistamine in the treatment of atopic dermatitis. 41. 2000 Principal Investigator of a phase IIIB study evaluating the comparative efficacy of a new antihistamine with an existing antihistamine. 42. 2000 Principal Investigator of a phase III study evaluating the potential effects of a sixweek course of an inhaled steroid in children, 2-4 years of age, with allergic rhinitis. 43. 2000 Principal investigator in a phase IV study evaluating the efficacy of a quinolone antibiotic for the treatment of sinusitis. 44. 2000 Principal Investigator of a study comparing the safety and efficacy of an inhaled steroid in a MDI versus an alternative delivery device for adult asthma patients. 45. 2000 Principal Investigator in a phase IV study evaluating the comparative efficacy of adding a leukotriene to subjects receiving inhaled beta2-agonist alone or inhaled beta2-agonist in combination with corticosteroids in patients over 12 years of age. 46. 2000 Principal Investigator in a phase III study evaluating the safety and comparative efficacy of a nebulized short-acting bronchodilators in pediatric subjects 6 years of age or older with asthma. 47. 2000 Principal Investigator in a phase III study evaluating the safety and efficacy of an antihistamine in the treatment of subjects 12-17 years of age with seasonal allergic rhinitis. 48. 2000 Principal Investigator in a phase III study evaluating the safety and efficacy, and tolerability of a long-acting bronchodilator in subjects 12-75 years of age with asthma. 49. 2000 Principal Investigator in a phase III study evaluating the efficacy of an antihistamine/ decongestant combination on nasal stuffiness in adult subjects over 12 years old with seasonal allergic rhinitis. 50. 2001 Principal Investigator of a study evaluating taste of a rapidly dissolving antihistamine tablet in children ages 4 to 11. Version 08/22/2005 14 51. 2000 Principal Investigator of a phase III study evaluating the efficacy and safety of an antiviral tablet medication in adult with common cold. 52. 2000 Principal Investigator of a phase III study evaluating the efficacy and safety of an antiviral oral medication in pediatric patients with common cold. 53. 2000-01 Principal Investigator of a phase IV study evaluating the effect of a nasal steroid on growth in pediatric patients with perennial allergic rhinitis. 54. 2000-01 Principal Investigator of a phase IV study evaluating the efficacy and safety of two different doses of inhaled steroid versus placebo given to infants 6-12 months with mild-moderate asthma. 55. 2000-01 Principal Investigator of a phase III comparison study of an inhaled steroid/long acting beta-agonist combination product vs. inhaled steroid alone for patients with moderate asthma. 56. 2000-01 Principal Investigator of a phase IV open label, parallel group study of an antiviral used for the management of influenza in households. 57. 2001-01 Principal Investigator of a phase III efficacy and safety study of a propellant in an inhaled steroid at three dosage strengths taken twice daily versus placebo in subjects 12 and older who are maintained on inhaled corticosteroids. 58. 2001-01 Principal Investigator of a phase III efficacy and safety study of a propellant in an inhaled steroid at three dosage strengths taken twice daily versus placebo in subjects 12 and older who are maintained on beta agonist only. 59. 2001-01 Principal investigator of an observational non-drug study to characterize the disease course and outcome of Respiratory Syncytial Virus (RSV) infection in otherwise healthy infants. 60. 2000-01 Principal Investigator of a phase III study of the effects of a antihistamine on the quality of life of subjects with a sleep disorder associated with symptomatic seasonal allergic rhinitis (SAR). 61. 2000-01 Principal Investigator of randomized, double-blind, double-dummy, parallelgroup comparison of an inhaled steroid with leukotriene chewable tablets in children 6-12 years of age with persistent asthma. 62. 2000-01 Principal Investigator of a phase III, a multi-center, randomized, controlled, openlabel study to evaluate the safety of an inhaled steroid in moderate to severe persistent asthma subjects already treated with other therapies Version 08/22/2005 15 63. 2001 Principal Investigator of a phase III study to evaluate the efficacy and safety of an inhaled steroid taken BID vs. QD PM compared to placebo in pediatric subjects 411 years old. 64. 2001 Principal Investigator of a phase IV evaluation of subject preference for a specific sensory attributes of two different nasal steroids in subjects with allergic rhinitis. 65. 2001 Principal Investigator of a phase III efficacy and safety of two different antihistamines (syrup) vs. placebo in the treatment of children ages 6 to 11 years with seasonal allergic rhinitis. 66. 2001 Principal Investigator of a phase III efficacy and safety of combination antihistamine/leukotriene QD vs. antihistamine/placebo QD in the treatment of subjects with seasonal allergic rhinitis. 67. 2001 Principal Investigator of a phase III efficacy and safety of a combination antihistamine/leukotriene QD vs. antihistamine/placebo in the treatment of subjects with seasonal allergic rhinitis and a history of perennial allergic rhinitis. 68. 2001 Principal Investigator of a screening protocol to identify subjects who exhibit difficulty in tolerating a high dose of pseudoephedrine. 69. 2001 Principal Investigator of a phase III efficacy and safety of a combination of a antihistamine 5 mg QD plus a decongestant 120 mg sustained release vs. a combination of a antihistamine 10 mg plus decongestant 240 mg QD sustained release vs. placebo in subjects with seasonal allergic rhinitis. 70. 2001 Principal Investigator of a phase IV, a randomized, double-blind, parallel group comparison of an inhaled steroid inhalation powder (50mcg BID) via with oral leukotriene (5mg QD) chewable tablets in children 6-12 years of age with persistent asthma. 71. 2001 Principal Investigator of a phase IV, a multi-center randomized, double-blind, double-dummy, parallel group-, 16 week comparison of asthma control in adolescents and adults receiving either an inhaled steroid combination product 100/50mcgBID, 100mcg BID, or beta agonist 10mg QD. 72. 2001 Principal Investigator of a phase III a double-blind, double-dummy, parallelgroup, multi-center, placebo-controlled, efficacy and safety Study of an inhaled steroid MDI 400 g/day, 800 g/day via two different delivery devices (inhaled steroid) 880 g/day administered twice daily for 12-weeks in the treatment of severe persistent asthma in adolescents and adults. 73. 2001 Principal Investigator of a phase III, a double-blind, double- dummy, randomized, placebo- and active-controlled, multi-center, parallel-group study of long acting Version 08/22/2005 16 beta agonist in the treatment of subjects with chronic obstructive pulmonary disease. 74. 2001 Principal Investigator of a phase IV, a randomized, double-blind, double-dummy, parallel-group, comparative clinical trial evaluating an inhaled steroid/beta agonist combination to a anti-cholinergic inhalation aerosol in subjects with chronic obstructive pulmonary disease (COPD) 75. 2001 Principal Investigator of a phase III, a double-blind, placebo-controlled study of the effect of an antihistamine in subjects with pernnial allergic rhinitis. 76. 2001 Principal Investigator of a phase III, a randomized, double-blind, multi-center trial comparing oral therapy with antibiotics 500mg/day for 3 Days (1.5 Grams), 500 mg/day for 6 days (3.0 Grams) and 500/125 mg TID for 10 days for the treatment of acute bacterial sinusitis. 77. 2001 Principal Investigator of a phase IV double-blind, double-dummy, parallel-group, multi-center, randomized, study of an antihistamine 180 mg vs an antihistamine 10 mg in subjects with moderate to severe seasonal allergic rhinitis (SAR) during the fall or winter/spring allergy season. 78. 2001 Principal Investigator of a phase III, a double blind, placebo-controlled study of an antihistamine in subjects with seasonal and/or perennial allergic rhinitis and concomitant asthma. 79. 2001 Principal Investigator of a phase III, a double-blind, placebo-controlled study of the effect of an antihistamine in subjects with perennial allergic rhinitis. 80. 2001 Principal Investigator of a phase IV, a randomized, double-blind, placeboconrolled, parallel-group, 12 week trial evaluating the efficacy and safety of an inhaled steroid combination product 250/50mcg once daily versus an inhaled steroid combination product 100/50mcg twice daily versus an inhaled steroid 250mcg once daily versus placebo in symptomatic adolescent and adult subjects with asthma that is not controlled on short acting beta-agonists alone. 81. 2001 Principal Investigator of a phase II, randomized, placebo-controlled, double-blind, parallel group, dose-finding study to evaluate the effectiveness of 28 days of treatment in adult asthmatics. 82. 2001 Principal Investigator of a phase III, a randomized, multi-center, placebocontrolled parallel group study of four months duration per patient to evaluate the safety and efficacy of treatment with 24µg b.i.d. and 12µg b.i.d. long acting beta agonist, double-blind, and 12µg b.i.d. long acting beta agonist with additional ondemand long acting beta agonist doses, open-label, in adolescent and adult patients with persistent stable asthma. Version 08/22/2005 17 83. 2001 Principal Investigator of a phase IIIb open-label, randomized, multi-center, parallel group, switching study to compare the efficacy and safety of three different lipid lowering agents with in high risk subjects with type IIa and IIb hypercholesterolemia. 84. 2001 Principal Investigator of a phase IV, rates of seroconversion following Varicella vaccination of asthmatic children between the ages of one and eight years treated with an inhaled steroid versus non-steroidal conventional asthma therapy. 85. 2001 Principal Investigator of a phase IV, a randomized, comparator controlled, double-blind study of the liver safety of three diabetes medications versus insulin as part of step therapy in subjects with type 2 (non-insulin dependent) diabetes. 86. 2001 Principal Investigator of a phase III, an efficacy, safety and tolerability study of daily dosing with a beta agonist and placebo in pediatric subjects 2-5 years old with asthma. 87. 2001 Principal Investigator of a phase IV, a stratified randomized, double-blind, placebo-controlled, parallel-group, 12 week trial evaluating the safety and efficacy of an inhaled steroid combination product 100/50mcg once daily versus an inhaled steroid 100mcg once daily and placebo in symptomatic pediatric subjects (4-11 years) with asthma. 88. 2001 Principal Investigator of a phase III, a randomized, double-blind, parallel-group, placebo-controlled 12-week trial of inhaled steroid 88mcg BID versus placebo in pediatric subjects 4-11 years of age with asthma. 89. 2001 Principal Investigator of a phase III multi-center, double-blind, placebo controlled, non-inferiority study assessing the effects of an inhaled steroid metered dose inhaler 50 µg/day and 200 µg/Day (ex-valve) administered once daily on growth in children with mild persistent asthma. 90. 2001 Principal Investigator of a phase III safety, tolerability and efficacy study of a short acting beta agonist in pediatric subjects birth to 48 months old with reactive airway disease in an acute setting. 91. 2001 Principal Investigator of phase III, a randomized, double-blind, double-dummy, placebo-controlled, parallel group clinical trials of four weeks treatment with a long acting beta agonist inhalation aerosol, 25mcg BID, 50mcg, BID and placebo administered via a valved holding chamber with facemask in subjects with asthma age 24 to 47 months. 92. 2001 Principal Investigator of a phase III, a multi-center, randomized, double- blind, parallel group, placebo-controlled, 12-week study of inhaled steroid 44mcg BID and 88mcg BID delivered Via CFC MDI and a valved holding chamber with facemask in subjects with asthma age 24 months to 47 months. Version 08/22/2005 18 93. 2001 Principal Investigator of phase III, a multi-center, randomized, double-blind, parallel group, placebo-controlled, 12 week study of an inhaled steroid 44mcg BID and 88mcg BID delivered via CFC MDI and a valved holding chamber with facemask in subjects with asthma age 6 months to 23 months. 94. 2001 Principal Investigator of a phase III, a safety and efficacy study of two dosagelevels of an inhaled steroid versus placebo in infants between the ages of six and twelve months with mild to moderate asthma. 95. 2001 Principal investigator of a phase III, an efficacy, safety and tolerability study of daily dosing with two beta agonists and placebo in pediatric subjects 2-5 years old with asthma. 96. 2001 Principal Investigator of a phase III, an efficacy and safety of inhaled steroid dry powder inhaler in the treatment of patients with COPD. 97. 2001 Principal Investigator of a phase II, a double-blind, placebo-controlled study of the effect of an antihistamine in subject with perennial allergic rhinitis. 98. 2001 Principal investigator of a phase IIIa 6-week, open-label, dose-comparison study to evaluate the safety and efficacy of four lipid lowering agents in subjects with hypercholesterolemia. 99. 2001 Principal Investigator of a phase III multi-center, randomized, double-blind, double-dummy, parallel group, 16-week comparison of asthma control in adolescents and adults receiving either an inhaled steroid via a combination product 100-50mcg BID, inhaled steroid via a 100mcg BID, or oral lukotriene 10mg QD. 100. 2001 Principal Investigator of a phase III double-blind, double-dummy, parallel-group, multi-center, placebo-controlled, efficacy and safety study of an inhaled steroid 400 µg/day, 800 µg/day (ex-valve) and another inhaled steroid 880 µg/day (exactuator) administered twice daily for 12 weeks in the treatment of severe persistent asthma in adolescents and adult. 101. 2001 Principal Investigator of a phase III, a double-blind, double-dummy, randomized, placebo- and active-controlled, multi-center, parallel-group study of a long acting beta-agonist in the treatment of subjects with COPD. 102. 2001 Principal Investigator of a phase III, multi-center, double-blind, placebo controlled, non-inferiority study assessing the effects of an inhaled steroid metered dose inhaler 50µg/day and 200 µg/day (ex-valve) administered once daily on growth in children with mild to persistent asthma. Version 08/22/2005 19 103. 2001 Principal Investigator of a phase III, a multi-center, randomized, open-label, one year long-term safety study of an inhaled steroid metered dose inhaler 50 µg/day to 200 µg/day (ex-valve) administered once daily or an inhaled steroid dry powder inhaler 50 µg or 100 µg administered twice daily for the treatment of children with persistent asthma ages 4 to 11. 104. 2001 Principal Investigator of a phase III, a randomized, double-blind, parallel-group, placebo-controlled 12-week trial of inhaled steroid 88mcg BID versus placebo in pediatric subjects 4 to 11 years of age with asthma. 105. 2001 Principal Investigator of a phase III, an efficacy, safety and tolerability study of daily dosing with two beta agonists and placebo in pediatric subjects with asthma. 106. 2001 Principal Investigator of a phase III stratified, randomized, double-blind, placebocontrolled, parallel-group, 12-week trial evaluating the safety and efficacy of the an inhaled steroid combination product 100/50mcg once daily and placebo in symptomatic pediatric subjects (4 -11 years) with asthma. 107. 2001 Principal Investigator of a phase IV, a randomized, multi-center, placebocontrolled parallel group study of four months duration per patient to evaluate the safety and efficacy of treatment with 24 µg b.i.d. and 12 µg b.i.d. long acting beta agonist, double-blind, and 12 µg b.i.d. a long acting beta agonist with additional on-demand doses, open-label, in adolescent and adult patients with persistent stable asthma. 108. 2001 Principal Investigator of a phase II randomized, double-blind study to compare the safety and efficacy of 20 mg of XXXXX versus placebo as replacement therapy for inhaled corticosteroid therapy in patients with severe asthma. 109. 2001 Principal Investigator of a phase IIIB, an open-label extension study of anti IgE in moderate to severe persistent asthma subjects 110. 2001 Principal Investigator of a phase II, randomized, placebo-controlled, double-blind, parallel group, dose-finding study to evaluate the effectiveness of 28 days of treatment with XXXX in adult asthmatics. 111. 2001 Principal Investigator of a phase IV, a randomized, double-blind, placebocontrolled, parallel-group, 12-week trial evaluating the efficacy and safety of the inhaled steroid combination product 250/50mcg once daily versus an inhaled steroid combination product 100/50mcg twice daily versus an inhaled steroid 250mcg once daily versus placebo in symptomatic adolescent and adult subjects with asthma that is not controlled on short acting beta agonists alone. 112. 2001 Principal Investigator of a phase III multi-center, double-blind, randomized, placebo-controlled, parallel-group study investigating the clinical effects of lukotriene inpatients with perennial allergic rhinitis. Version 08/22/2005 20 113. 2001 Principal Investigator of a phase III, a double-blind, placebo-controlled study of the effect of an antihistamine in subjects with perennial allergic rhinitis. 114. 2001 Principal Investigator of a phase III, a multi-center, randomized, single-blind, single exposure, cross-over evaluation of subject preference for specific sensory attributes of two nasal steroids in subjects with allergic rhinitis. 115. 2001 Principal Investigator of a phase II, a double-blind, placebo-controlled study of an antihistamine in subjects with seasonal and/or perennial allergic rhinitis and concomitant asthma. 116. 2001 Principal Investigator of a phase III, a double-blind, double-dummy, parallelgroup, multi-center, randomized, study of an antihistamine 180 mg vs an antihistamine 10 mg in subjects with moderate to severe seasonal allergic rhinitis (SAR) during the fall or winter/spring allergy season. 117. 2002 Principal Investigator of a phase III, a multi-center, double blind, randomized, parallel study comparing the efficacy and safety of two antihistamines120 mg BID, 240 mg QD, and placebo in subjects with perennial allergic rhinitis. 118. 2002 Principal Investigator of a phase III for a multi-center, double blind, randomized, parallel groups placebo controlled study to assess the efficacy and safety of an antihistamine 120 mg BID in subjects with mild to moderate persistent asthma. 119. 2002 Principal Investigator of a Phase III, randomized triple blind, parallel-group, long term, placebo controlled, multi-center study to examine the effect on glucose control (HbA1c) of AC 2993 given two times a day in subjects with type 2 diabetes mellitus treated with a sulfunyurea alone. 120. 2002 Principal Investigator of a randomized (2:1), stratified, double blind, parallelgroup, placebo-controlled, 12-week, multi-center trial of inhaled steroid inhalation aerosol 88 mcg BID versus placebo HFA delivered via an MDI and a valved holding chamber with facemask in pediatric subjects 1 to < 4 years of age with asthma. 121. 2002 Principal Investigator of a phase III placebo- and active- controlled efficacy and safety study of a one-daily fixed combination tablet of antihistamine/decongestant in subjects with seasonal allergic rhinitis. 122. 2002 Principal Investigator of a double blind, randomized, placebo- and active controlled, multicenter, parallel-group trial of a beta-agonist in subjects 12 years of age and older with asthma. 123. 2002 Principal Investigator of a phase III, randomized, triple-blind, parallel-group, long-term, placebo-controlled, multicenter study to examine the effect on glucose Version 08/22/2005 21 control (HbA1c) of AC2993 given twice daily in subjects with type 2 diabetes mellitus treated two oral hypoglycemic medications. 124. 2002 Principal Investigator of a six-month, randomized, open-label safety study of two inhaled steroids compared in asthmatic children aged 6-11 years. 125. 2002 Principal Investigator of a phase III, a placebo-controlled comparison of the efficacy, safety and pharmacokinetics of the current US version of an inhaled steroid and the new version of an inhaled steroid in asthmatic children and adolescents. 126. 2002 Principal Investigator of a phase III, a twelve-week, randomized, double-blind, double-dummy, placebo-controlled trial of an inhaled steroid/beta agonist combination (80/4.5 mcg) versus its mono-products (inhaled steroid/long acting beta agonist) in children (>6 years of age) and adults with asthma. 127. 2002 Principal Investigator of a phase III, a twelve-week, randomized, double-blind, double-dummy trials of an inhaled steroid versus its mono-products (inhales steroid/long acting beta agonist) in asthmatic children aged six to fifteen years. 128. 2002 Principal Investigator of a phase II, a dose response and pharmacodynamic study of two beta agonist in subjects twelve years of age and older with asthma. 129. 2002 Principal Investigator of a phase III, an efficacy and safety study of two beta agonist and placebo in subjects twelve years of age and older with asthma. 130. 2002 Principal Investigator of a phase II dose ranging study in patients with persistent asthma not treated with inhaled corticosteroids. 131. 2002 Principal Investigator of a phase III, a twelve week treatment with 125 mcg of phosphodiesterase antagonist versus 250 mcg versus placebo in patients with asthma. 132. 2002 Principal Investigator of a phase II, a randomized, multi-center, open-label, active controlled, single dose, 5 period, incomplete block, cross over study to evaluate the relative bronchodilating effects of a long acting beta agonist when administered via an inhaled steroid delivery device to adults with stable asthma. 133. 2002 Principal Investigator of a phase III, a multi-center, randomized, parallel-group, double-blind, efficacy and safety study of a nasal spray versus placebo in subjects with perennial allergic rhinitis. 134. 2002 Principal Investigator of a phase IIIa, multi-center, randomized, double-blind, parallel-group, placebo-controlled study on the efficacy and safety of an antihistamine 180 mg once daily in chronic idiopathic urticaria. Version 08/22/2005 22 135. 2002 Principal Investigator of a phase III, efficacy and safety of inhaled human insulin compared with subcutaneous human insulin in the therapy of adult subjects with type 1 or type 2 diabetes mellitus and chronic asthma: A one-year, multi-center, randomized, outpatient, open-label, parallel-group comparative trial. 136. 2002 Principal Investigator of a phase IV, a multi-center prospective, randomized, double-blinded, parallel group study comparing the effects of three calcium channel blockers plus ace inhibitor (5/20mg), (5mg) and (20mg) on systolic blood pressure and pulse pressure in patients with systolic hypertension. 137. 2002 Principal Investigator of a phase II , randomized, double-blind, placebocontrolled, parallel-group study of an immuno-suppressive in patients with chronic persistent asthma. 138. 2002 Principal Investigator of a phase II, systolic and pulse pressure hemodynamic improvement by restoring elasticity. 139. 2002 Principal Investigator of a phase I, a multi-center, double-blind, randomized, placebo-controlled, parallel study to assess the safety and tolerability of an antihistamine 30 mg in children with allergic rhinitis. 140. 2002 Principal Investigator of a phase III, a twelve-week, randomized, double-blind, double-dummy, active controlled study of an inhaled steroid administered once daily in children and adolescents 6 to 15 years of age with asthma. 141. 2002 Principal Investigator of a phase III, a placebo-controlled comparison of the efficacy and safety of the current US version of an inhaled steroid and the new version of an inhaled steroid in asthmatic adults currently treated with inhaled steroids. 142. 2002 Principal Investigator of a 12- week, randomized, open-label, 3-arm parallelgroup, multi-center, phase IIIb study comparing the efficacy and safety of two different lipid lowering agents achieving NCEP ATP III LDL-C goal in high-risk subjects with hypercholesterolemia in the managed care setting. 143. 2002 Principal Investigator of a phase III, double blind, double dummy, randomized, placebo- and active-controlled, multi-center, parallel-group study of a long acting beta agonist in the treatment of subjects with chronic obstructive pulmonary disease. 144. 2002 Principal Investigator of an observational study to evaluate the disease course of bronchial asthma in children 6 to 12 years of age during the rhinovirus cold season. 145. 2002 Principal Investigator of a phase III an open-label extension study II of an IgE in moderate to severe, persistent asthma subjects. Version 08/22/2005 23 146. 2002 Principal Investigator of a phase II, randomized, double-blind, placebo-controlled, parallel-group pilot study in patients with symptomatic steroid-naïve asthma. 147. 2002 Principal Investigator of a phase III multiple dose safety and tolerance study of an antihistamine in atopic pediatric subjects with chronic idiopathic urticaria, ages 2 to <12 years, who are poor metabolizers of an antihistamine. 148. 2002 Principal Investigator of a phase III, randomized, triple blind, placebo controlled, parallel group, multicenter study to examine the effect on glucose control (HbA1c) of AC2993 given twice a day in subjects with type II diabetes mellitus treated with biguanide alone. 149. 2002 Principal Investigator of a phase II, inhaled corticosteroid replacement studyefficacy and safety of a vascular cell adhesion molecule antagonist in moderate persistent asthma. 150. 2003 Principal Investigator of a phase III, a center specified sub-study of peripheral nerve conduction studies in patients with painful diabetic neuropathy enrolled in “A 15 week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study for efficacy and quality of life in patients with painful diabetic peripheral neuropathy” 151. 2003 Principal Investigator of a phase III, efficacy and safety of inhaled human insulin compared with subcutaneous human insulin in the therapy of adult subjects with type 1 or type 2 diabetes mellitus and chronic obstructive pulmonary disease: A one-year, multi-center, randomized, outpatient, open-label, parallel-group comparative trial. 152. 2003 Principal Investigator of a phase IV safety trial in pediatric patients (ages 2-5) with rhinorrhea associated with a common cold or allergy. 153. 2003 Principal Investigator of a phase III, an efficacy, safety, and tolerability study of daily dosing with two beta agonist, and placebo in pediatric subjects with asthma. 154. 2003 Principal Investigator of a phase IIa, a multi-center, randomized, double-blind, crossover study comparing the effect of L-45460 and placebo in adult patients with chronic asthma. 155. 2003 Principal Investigator of a phase IIa, a double-blind, randomized, placebo- and active-controlled, multi-center, parallel-group, proof-of-concept study of L000454560 in patients with COPD. 156. 2003 Principal Investigator of a phase III, a long term safety of two beta agonist in subjects twelve years of age and older with asthma. Version 08/22/2005 24 157. 2003 Principal investigator of a phase III, study of an open label, multi-center study to evaluate the performance and patient satisfaction of an inhaled steroid/long acting beta agonist combination with counter in Asthma or COPD subjects at least 12 Years of age. 158. 2003 Principal investigator of a phase III, study of an open-label, multi-center study to evaluate the performance and patient satisfaction of a beta agonist with counter in asthma or COPD subjects at least 4 years of age. 159. 2003 Principal investigator of a phase III, study of a four-week, randomized, doubleblind, placebo-controlled, parallel-group, multi-center study of a bronchial dilator delivered with a facemask and two different holding chambers in subjects aged 24 to <48 months with asthma symptoms (i.e. wheeze, cough, dyspnea or chest tightness) or consisten with asthma or obstructive airway disease or bronchiospasm. 160. 2003 Principal investigator of a phase II double-blind, randomized, placeo-controlled, dose-ranging trial with Lidocaine Solution for inhalation (LSI) in mild to moderate asthma patients. 161. 2003 Principal investigator of a phase III open-label extension study of Protocol 2993113 to examine the long-term effect on glucose control (HbA₁с) and safety and tolerability of an oral medication given two times a day to subjects treated with a sulfonylurea alone. 162. 2003 Principal Investigator of a phase IV randomized, multi-center, parallel-group, double-blind, vehicle-controlled study to evaluate the time of pruritus improvement during the first week of a steroid cream treatment in patients ≥2 years old with mild to moderate atopic dermatitis. 163. 2003 Sub-investigator of a phase of a multi-center, controlled, randomized, open label study substituting Lantus® (insulin glarine [rDNA Origin] injection) for a thiazolidinedione Vs. a third oral agent as add-on therapy in patients failing a thiazolidinedione and sulfonylurea or glucopheage® (metformin) combination. 164. 2003 Principal investigator of a phase III long term safety study of a Nasal Spray. 165. 2003 Principal investigator of a phase II 24 week, placebo-controlled, randomized, parallel group study comparing Roflumilast 500 mcg daily vs. placebo on pulmonary function and respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD). 166. 2003 Principal Investigator of a phase III, a multi-center, double-blind, randomized, placebo controlled, parallel group study Investigating the clinical effects of a leukotriene in patients with PAR Version 08/22/2005 25 167. 2003 Principal Investigator of a phase II, a multicenter, randomized, double-blind, placebo-controlled, parallel group, dose finding study evaluating the safety and efficacy of an infusion administration in symptomatic subjects with moderate to severe chronic obstructive pulmonary disease (COPD) 168. 2003 Principal Investigator of a phase III, a two-stage randomized, open-label, parallel group, multicenter, 7-month study to assess the efficacy and safety of an inhaled steroid administered either as fixed or as an adjustable regimen versus a fixed regimen of an inhaled steroid in subjects 12 years of age and older with Asthma. 169. 2003 Principal Investigator of a phase IV, efficacy and safety of a nasal steroid vs. Placebo in subjects with SAR and Concomitant asthma. 170. 2003 Prinicipal Investigator of a phase II, a four-week, double-blind, placebocontrolled exploratory evaluation of FEV 1.0 changes and safety of a COPD medication in patients with Chronic Obstructive Pulmonary Disease (COPD) 171. 2003 Sub-Investigator of a phase IV, a randomized, single-blind, placebo controlled, parallel group, exploratory research study to describe the pharmacodynamic effects of three diabetes medications versus placebo for 8 weeks in adult subjects with type 2 diabetes mellitus. 172. 2003 Sub-Investigator of a phase III, a randomized, 2-period, multicenter, double-blind, parallel-group study comparing the effects of 2 doses of a leukotriene and Placebo in the treatment of respiratory symptoms associated with Respiratory Syncytial Virus-Induced Bronchiolitis in children aged 6 to 18 months. 173. 2003 Sub-Investigator of a phase III multicenter, multinational, randomized, doubleblind, parallel group study of the effects of an inhaled steroid on lens opacification in adult subjects with moderate to severe persistent asthma. 174. 2003 Sub-Investigator of a phase IV randomized, double-blind, double-dummy, placebo-controlled, parallel group, multi-center clinical trial of four weeks treatment with long acting beta agonist, 25mcg BID, 50mcg BID and placebo administered via a valved holding chamber with facemask in subjects with symptoms of asthma or Reactive Airways Disease Age 6 to 23 months. 175. 2003 Sub-Investigator of a phase IV, a stratified, multicenter, randomized, doubleblind, parallel group, 4-week comparison of an inhaled steroid/long acting beta agonist combination product 100/50mcg BID versus an inhaled steroid 100mcg BID in pediatric subjects with activity induced bronchospasm. 176. 2003 Sub-Investigator of a phase III, randomized, double-blind, placebo-controlled, parallel-group trial to assess the safety and efficacy of nasa spray (200ug once daily) applied as a nasal spray in the treatment of perennial allergic rhinitis (PAR) in patients 12 years of age and older. Version 08/22/2005 26 177. 2003 Sub-Investigator of a phase II, multicenter, double-blind, randomized, parallelgroup study investigating the clinical effect of XXXX in patient with seasonal allergic rhinitis - a pilot study during the fall Season. 178. 2003 Sub-Investigator of a phase III, an open-label study to determine the efficacy and safety of an angiotensin II receptor antagonist and hydrochorthiazide in patients with hypertension uncontrolled on monotherapy 179. 2004 Principal Investigator of a phase III, randomized, controlled study of rolumilast (250 mcg and 500 mcg) versus placebo in patients with asthma. A 24-week, multicenter, multinational, double-blind, parallel group clinical study. 180. 2004 Sub-Investigator of a phase III study for the effect of roflumilast on exacerbation rate in patients with chronic obstructive pulmonary disease. A 52 week, multicenter, double-blind, study with 500 mcg roflumilast once daily versus placebo. 181. 2004 Sub-Investigator of Phase III, A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term (48 weeks) Safety of a Nasal Spray (200ug, once daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older. 182. 2004 Sub-Investigator of a phase III, Comparison of the Safety and Efficacy of Intravenous Iron versus Oral Iron in Chronic Renal Failure Subjects with Anemia 183. 2004 Sub-Investigator of a phase IIIa, a randomized, double-blind, parallel group, placebo-controlled, four-week efficacy and safety evaluation of a nasal spray 110 mg QD, followed by six-month open-label safety in children ages 2-5 years with perennial allergic rhinitis 184. 2004 Sub-Investigator of a phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of XXXX Biologicals’ herpes simplex candidate vaccine (XXXX) in healthy HSV seronegative and seropositive female subjects aged 10 – 17 years 185. 2004 Sub-Investigator of a phase III, Assessment of the Pharmacokinetics and the Pharmacodynamics of XXXX in Patients with Moderate to Severe Emphysema. 186. 2004 Principal Investigator of a phase Efficacy And Safety of a tricyclic antihistamine 10 mg daily Versus Placebo In Subjects With Allergic Airway Disease During The Pollen Season. 187. 2004 Sub-Investigator of a phase trial of Antineoplastics followed by monoclonal antibody maintenance in previously treated low grade non-hodgkins lymphoma. Version 08/22/2005 27 188. 2004 Sub-Investigator of a phase A prospective, multicenter, randomized, phase II study to evaluate the effects of Zoledronic acid in combination with a chemotherapy drug/carboplatin in patients with stage IIIB/IV unresectable nonsmall cell lung cancer. 189. 2004 Sub-Investigator of phase A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of a Nasal Spray at Three Dose Levels (100 mg, 200mg, or 25mg, once daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6–11 Years of Age. 190. 2004 Sub-Investigator of a phase IV, A multicenter, open-label, study of of Pegfilgrastin adminisered in the first and subsecquent cycles of Myclosuppresive Chemotherapy. 191. 2004 Sub-Investigator of a phase An Open-Label, Non-Randomized, Parallel-Group, Study of an anticoagulant Pharmacokinetics in Subjects With Normal Renal Function and Subjects With Mild and Moderate Renal Impairment Receiving 36 mg of an anticoagulant Twice Daily and in Subjects With Severe Renal Impairment Receiving 24 and 36 mg of an anticoagulant Once Daily. 192. 2004 Sub-Investigator of a phase safety and efficacy evaluation of two doses of HFAPropelled corticosteroid versus placebo by breath operated and metered dose inhalers in moderate asthmatic adolescents and adults on a stable regimen of inhaled corticosteroids. 193. 2004 Sub-Investigator of a phase safety and efficacy evaluation of two doses of HFA apropelled corticosteroid versus placebo by breath operated and metered dose inhalers in mild to moderate asthmatic children. 194. 2004 Sub-Investigatorr of a phase Pharmacodynamics of the 88mcg BID dose of the hydrofluoroalkane propellant formulation of an inhaled steroid following administration via the metered-dose inhaler in pediatric subjects 4 to 11 years of age with asthma 195. 2004 Sub-Investigaor of a phase A randomized, double-blind, active-controlled, parallel-group, single-dummy, multicenter, 12 week study to assess the efficacy and safety of an inhaled steroid 160/4.5 g x 2 actuations once-daily (QD) compared to an inhaled steroid 80/4.5 g x 2 actuations QD, an inhaled steroid 80/4.5 g x 2 actuations twice-daily (BID) and to an inhaled steroid 160 g x 2 actuations QD in asthmatic subjects 12 years of age and older. 196. 2004 Principal Investigator of a phase 2, Randomized, Double-Blind, PlaceboControlled, Multicenter Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects. Version 08/22/2005 28 197. 2004 Sub-Investigator of a phase Multicenter, Randomized, Double-Blind, PlaceboControlled, Parallel-Group Study of 3 Fixed Doses of XXXX in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy, 198. 2004 Principal Investigator of a phase A Randomized, Parallel Group, Double-Blind, Comparative Trial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Persistent Asthma, Who Have Either a XXXX, a XXXX or a XXXX Genotype and are Treated with inhaled steroid DISKUS Combination Product 100/50mcg BID or an inhaled steroid DISKUS 50mcg BID. 199. 2004 Sub-Investigator of a Comparison of the Pharmacokinetic Profiles of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Pediatric Healthy Volunteers 200. 2004 Sub-Investigator of a phase A Placebo Controlled Study of the Efficacy and Safety of tricyclic antihistamine vs. another antihistamine 180 mg. in the Treatment of Subjects with Symptomatic Seasonal Allergic Rhinitis (SAR). 201. 2004 Sub-Investigator of a phase A Multi-center, Double-blind, Randomized, Placebocontrolled, Parallel Group, Phase II Study to Assess the Efficacy and Safety of Nasal Spray 16 mcg, 32 mcg, and 64 mcg per day versus placebo in Pediatric Subjects, Ages 2-5 Years Old with Allergic Rhinitis. 202. 2004 Sub-Investigator of a Double-Blind, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of nasal spray combination in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis. 203. 2004 Sub-Investigator of study to define the non-restorative sleep population. 204. 2004 A 24-Week Randomized, Double-Blind, Multi-Centre, Active-Controlled (pioglitazone) Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy when Administered to Patients with Type 2 Diabetes. 205. 2004 A Multicenter, randomized, double-blind, double-dummy, parallel group, 42 week comparison of asthma control in hyperresponsive adolescents and adults receiving either inhaled steroid combination product BID or inahled steroid BID 206. 2005 Sub-Investigator of an Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Glucorticoid Nasal Spray when Administered Concomitantly with Orally Inhaled corticosteroid in Patients (18-60 Years) with Perennial Allergic Rhinitis (PAR) 207. 2005 Sub-Investigator of a Safety and Efficacy of selective H1 receptor antagonist Nasal Spray in Pediatric Patients 208. 2005 Sub-Investigator of A Double-Masked, Multiple-Dose, Three-Arm, Version 08/22/2005 29 Parallel-Design Safety and Pharmacokinetic Study of Selective H1 receptor antagonist Following Administration of selective H1 receptor antagonist Nasal Spray in Pediatric Patients 2 to 5 Years of Age 209. 2005 Sub-Investigator of A randomized, double-blind, placebo controlled, parallel group, 6-week study of the effect of XXXX aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in pediatric subjects 2 to <12 years of age with perennial allergic rhinitis (PAR). 210. 2005 Sub-Investigator of A Randomized, Double-Blind, Placebo-Controlled, ParallelGroup, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of XXXX Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to <12 Years with Perennial Allergic Rhinitis (PAR) 211. 2005 Sub-Investigator of an Effect of 24 Week Treatment With XXXX Versus Placebo And Montelukast As Add-On Therapy To an Inhaled corticosteroid Followed By 24 Week Extension Treatment In Persistent Asthma 212. 2005 Sub-Investigator of a Phase IV: A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving an inhaled corticosteroid 100/50mcg DISKUS BID or inhaled corticosteroid 100mcg DISKUS BID Alone 213. 2005 Sub-Investigator of A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of XXXX (2.5mg, 7.5mg, 15mg, 30mg and 45mg), Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension 214. 2005 Sub-Investigator of A Double-Blind, Multi-Centre, Active-Controlled, (pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of a thiazolidinedione in Patients with Type 2 Diabetes Mellitus 215. 2005 Principal Investigator of a Pilot Efficacy and Safety Field Trial of an anthihistamineAdministered Concomitantly with an antispasmadic, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip 216. 2005 Principal Investigator of An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group study to demonstrate the safety and Bioequivalence of gluco corticosteroid nasal spray compared with a nasal spray 55mcg in the releif of thes signs and symptoms of seasonal allergic rhinitis (SAR) Version 08/22/2005 30 217. 2005 Principal Investigator of a 12 week double blind, parallel group placebo and active controlled trial to evaluate the efficacy and safety of a long acting beta agonist inhalation solution in the treatment of COPD 218. 2005 Principal Investigator of a Comparative Double-Blind, Double-Dummy Study of tricyclic antihistamine 5mg Once Daily, a second-generation H1-receptor antagonist antihistamine 10mg Once Daily, and Placebo Once Daily in Patients with Chronic Idiopathic Urticaria (CIU). 219. 2005 Principal Investigator of a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Oncedaily, Intranasal Administration of XXXX Aqueous Nasal Spray 50mcg and 100mcg for 2 weeks in Pediatric Subjects Ages 2 to <12 Years with Seasonal Allergic Rhinitis (SAR).- 220. 2005 Sub-Investigator of a Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Aqueous Nasal Spray 200mcg QD versus an oral leukotriene receptor antagonist10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving inhaled steroid by DISKUS 100/50mcg BID or Placebo BID – 221. 2005 Sub-Investigator of a Randomized, Double-Blind, Placebo-Controlled, ParallelGroup, Multicenter Study to Evaluate the Efficacy and Safety of XXXX Inhalation Powder 200mcg Twice-Daily, XXXX Inhalation Powder 200mcg Once-Daily, and XXXX Inhalation Powder 400mcg Once-Daily in the Morning Compared with Placebo for 8 Weeks in Adolescent and Adult Subjects (12 Years of Age and Older) with Persistent Asthma Symptomatic on Low-Dose ICS Therapy 222. 2005 Principal Investigator of a Randomized, 24-week, Double-blind, Placebocontrolled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of Ariflo (15mg BID) in Patients with Chronic Obstructive Pulmonary Disease (COPD). 223. 2005 Sub-Investigator of a placebo-and active-controlled (ciclesonide metered-dose inhaler), randomized, parallel-group, dose-range finding study of ciclesonide administered by dry powder inhaler in adult and adolescent patients with persistent asthma Phase 1 Studies: 2001- Principal Investigator of a phase I, a safety study of an antihistamine (syrup) in pediatric subjects two to eleven months of age. Version 08/22/2005 31 2001 Principal Investigator of a phase I, a randomized, parallel-group, double-blind multicenter, placebo-controlled, 15 day safety study of an antihistamine syrup in children 6 months to 2 years old 2001 Principal Investigator of a phase I, a multi-center, double-blind, randomized, placebo-controlled, parallel study to assess the safety and tolerability of an antihistamine 15mg in children with allergic rhinitis. 2002- Principal Investigator of a phase I, an open-label, screening protocol to determine the metabolic phenotype of atopic pediatric subjects and pediatric subjects with chronic idiopathic urticaria (ages ≥ 2 to < 12 years) 2002- Principal Investigator of a phase I, a stratified, randomized, double-blind, parallelgroup, 12-week trial evaluating the safety and efficacy of the inhaled steroid combination product 100/50mcg BID versus an inhaled steroid 100mcg BID in symptomatic pediatric subjects (4-11 years) with asthma. 2002- Principal Investigator of a phase I, a 12-week, randomized double-blind, placebocontrolled, 3-way crossover study in adult subjects with asthma aged 18-55 years to examine the pharmacodynamics and pharmacokinetics of an inhaled steroid administered twice daily via the DISKUS and the inhaled steroid combination product (100mcg/ 50mcg) administered twice daily via the DISKUS. 2002- Principal Investigator of a phase I, an open-label, single-dose, randomized, fiveway cross-over study of a long acting beta agonist and racemic fumarate in mild to moderate asthmatics. 2003- Principal Investigator of a phase I, distribution of the clearance and terminalphase half-life of an antihistamine 30 mg (Population Pharmacokinetic Screen) 2003- Principal Investigator of a phase I 16-week, randomized, double-blind, doubledummy, placebo-controlled, 4-way crossover study in adult subjects with asthma aged 18-55 years to examine the pharmacodynamics and pharmacokinetics of an inhaled steroid and a long acting beta agonist administered via an inhaled steroid and long acting beta agonist combination product, an inhaled steroid/long acting beta agonist combination metered dose inhaler (MDI) (110mcg/21 mcg) containing the hydrofluoroalkane (HFA) propellant containing HFA propellant. 2003- Principal Investigator of a phase I study of an open-label, three-way, crossover pharmacokinetic study of a long acting beta agoinst and a long acting beta agonist Dry Powder Inhaler in Healthy Pediatric Subjects Ages 5 to 12 years. 2003- Principal Investigator of a phase I, a randomized, open-label, 2-way crossover, repeat-dose study in pediatric subjects with asthma, age 4-11 years of age, to compare systemic exposure of an inhaled steroid 2x44 mcg following Version 08/22/2005 32 administration by metered-dose inhalers containing hydrofluoroalkane or Chlorofluorocarbon propellants. 2004- Principal Investigator of a Phase I, Open-Label, Pharmacokinetic Study Measuring Plasma Exposure of a 20 mg Single Dose Administration of lipid inhibitor to Healthy Asian Subjects Living in the United States Related to Historical Pharmacokinetic Data Obtained from Caucasians 2004 Sub-Investigator of a phase I Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Multiple Doses of a proton pump inhibitor in a Pediatric Population of 1 to 11 Year-Olds with Gastroesophageal Reflux Disease (GERD) or Symptoms of GERD. 2004- Principal Investigator of a phase I 2-week, randomized, double-blind, parallelgroup study in pediatric subjects with asthma aged 4 to 11 years to examine the pharmacokinetics of an inhaled steroid combination product administered twice daily via the Diskus and the FP Diskus (FP 100mcg) 2004 Principal Investigator of a phase I randomized, open-label, 3-period crossover, drug interaction study between a cholesterol lowering drug (40mg) and (4mg) in healthy subjects. 2004 Principal Investigator of a phase I open-label, four-way, crossover pharmacokinetic study of inhaled steroid and a dry powder inhaler in patients with chronic obstructive pulmonary disease. 2004 Sub Investigator of a Phase I A Double-Masked, Multiple-Dose, Five-Arm, Parallel-Design Safety and Pharmacokinetic Study of antihistamine following Administration of Nasal Spray in Pediatric Patients 6 To 11 Years of Age. 2005 Sub-Investigator of a phase I Randomized, Double-blinded, Single-dose, Twotreatment, Two-sequence Crossover Study of in vivo Pharmacodynamic Effects of the Generic Version of an anticoagulant Injection vs. another anticoagulant for Determination of Pharmaceutical Equivalence 2005 Sub-Investigator of a Phase I Multicenter Study to Assess the Safety and Pharmacokinetics of Open-Label 30 mg Single Dose of an H1 receptor antagonist Oral Suspension (6 mg/ml) in Pediatric Subjects 2 to 5 Years of Age 2005 Principal Investigator of a phase I Open Label, Randomized, Multiple Dose, 3Way Crossover Study of adrenergic beta receptor agonist Inhalation Solution and Racemic Formoterol in Subjects with Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) Version 08/22/2005 33 2005 Principal Investigator of phase I Single oral dose study to evaluate tolerability, safety and phamacokinetics of RO0272441, a dual α4 / β1 and α4 / β7 integrin antagonist in adolescent, asthmatic patients 2005 Sub-Investigator of A Phase I Randomized, Double-blinded, Single-dose, Twotreatment, Two-sequence Crossover, Relative Bioavailability Study Comparing an intraveous anesthetic (1% Propofol Injectable Emulsion) to the another intravenous anesthetic. 2005 Sub-Investigator of a Tolerability and Safety of a selective serotonin reuptake inhibitor in Combination with an alpha 1 antagonist 2005 Sub-Investigator of a phase I, double-blind, placebo-controlled, safety, pharmacokinetic and pharmacodynamic study of XXXX administered as single escalating inhaled doses to sequential groups of healthy adult male subjects. 2005 Sub-Investigator of a phase I Study Influence of Race/Ethnic Origin on the Pharmacokinetics and Pharmacodynamics of SCH XXXXX. Version 08/22/2005 34
