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WINTER 2014 T h e Spirog ram What is going on with E-Cigarettes? ! ! ! ! ! ! CONTRIBUTORS ! !! !! E-cigarettes, or electronic cigarettes, are battery-powered devices that appear similar to cigarettes and deliver a vaporized solution of nicotine and propylene glycol. These devices come in a variety of appearances and flavorings, including tobacco, menthol, chocolate, fruit and coffee, with over 250 brands on the market. Prices range from $30-150 for the device and $10-20 for the cartridges, with one cartridge typically lasting as long as one pack of cigarettes. Approximately 21% of current smokers in the US have ever used an e-cigarette at least once. The manufacturers of e-cigarettes claim that they are safer than real cigarettes because they deliver only nicotine and not the hundreds of known other toxic chemicals found in tar and other components of cigarette smoke. However, these claims are not tested or supported by the Food and Drug Administration (FDA), although the FDA announced in 2011 that such regulations are planned. ANNE DIXON, MD DAVID KAMINSKY, MD RESEARCH COORDINATORS ! STEPHANIE BURNS JOAN LIPPMANN PATTI LUTTON MEENA SUBRAMANIAN ! ! ! INSIDE THIS ISSUE: E-Cigarettes 1 New Faculty Interview 2 Ongoing Studies 3 COPD 4 The FDA has a number of concerns about ecigarettes. One is that they may deliver small amounts of carcinogenic nitrosoamines, diethylene glycol or other toxic substances. Although these amounts appear to be low, they are higher than other forms of FDA-approved nicotine replacement therapy, such as chewing gum, lozenges and skin patches. In addition, no one knows what the long-term effects might be of exposure to these low-level toxins. Another concern is that there is wide variability in the amount of nicotine delivered per puff. Nicotine itself, which is highly addictive, can cause high blood pressure and heart rate, as well as nausea, sweating and diarrhea. Finally, many manufacturers make David Kaminsky MD unsubstantiated claims that e-cigarettes may help smoking cessation. ! Other public health concerns about ecigarettes are that current smokers may become addicted to them rather than quitting smoking, and they may appeal to nonsmokers or young adults who might otherwise not use nicotine products. In this latter regard, there is worry that teens who use e-cigarettes will be more likely to smoke cigarettes, just as has been observed in teens who use smokeless tobacco. Another important concern is that ecigarettes might be used in public places, thus undermining all the efforts that have been used to eliminate smoking and exposure to smoking byproducts in these places. ! A number of surveys of e-cigarette users have revealed that these devices may help smokers reduce or quit real cigarettes, although these surveys might be biased because they are typically filled out by people who are enthusiastic about e-cigarettes. Only limited information from research studies is available, but one study was able to show that over 6 months, regular cigarette smokers were able to reduce or quit smoking altogether. Commonly reported side effects of e-cigarettes include dry mouth, throat irritation, cough, headache and dizziness. ! Although potentially promising as a tool to aide in smoking cessation, at the present time there are too many concerns and uncertainties surrounding e-cigarettes to recommend their use. The FDA will be dealing with a number of issues, including assessing long-term benefits and toxicity through controlled clinical trials, and regulation of production, marketing and licensing. Until these issues are resolved, health care providers should continue to focus their efforts on reducing and eliminated use of tobacco products rather than promoting ecigarettes. WWW.VERMONTLUNG.ORG WINTER 2014 Interview with New Faculty Member C. Matthew Kinsey, MD MPH Where did you grow up? teachers. ! I was raised in rural Idaho. My parents worked as Where did you attend school? I studied chemistry and molecular biology at The University of Idaho and then attended medical school at the Albert Einstein College of Medicine. Following completion of medical school training, I moved to Boston to pursue Internal Medicine Residency training at Beth Israel Deaconess Medical Center and subsequently Pulmonary and Interventional Pulmonary Fellowship through Massachusetts General Hospital. I just completed an MPH at the Harvard School of Public Health, a degree focused on clinical and translational research. ! Why did you choose to live in Vermont? I wanted to work here for several reasons. I was very impressed with the care provided at Fletcher Allen, there were many interesting and innovative research programs, and most importantly I really liked the people I met when I visited. Vermont is also a beautiful place and we love spending time outside. ! What are your favorite things to do in your free time? I’m married and have two children, Katherine 2 years old, and Charlotte who is 6 months old. We like to take Katherine skiing, which involves half skiing and half hot dog eating. ! You are listed for “Interventional Pulmonology” – what exactly does that involve? Interventional Pulmonology (IP) is a branch of the specialty of Pulmonary Disease that involves performing a variety of procedures – “interventions” – that can correct problems in the airways, the lung tissue, or the space surrounding the lung (the pleural space). One example would be a situation where a lung cancer is blocking off a large airway, making it difficult for the patient to breathe. The “intervention” might involve removing cancer tissue from within the airway using a long tube (a bronchoscope), opening up the airway, and then placing a stent to keep the airway open. We also treat pleural effusions, and non-cancerous disease of the airway such as tracheobronchomalacia (abnormally weak cartilage in the airway). Were you trained specifically for Interventional Pulmonology? Yes, I undertook 2 years of clinical and research training in Interventional Pulmonary at Massachusetts General Hospital in Boston after I completed the 3-year fellowship in Pulmonary and Critical Care Medicine. ! Will you be bringing some new procedures to our medical center? Several of the procedures performed under Interventional Pulmonology are already active here, performed by other Pulmonary or Thoracic Surgery specialists. I perform additional techniques to diagnose pulmonary nodules and masses. I also use techniques such as laser, cryotherapy, and photodynamic therapy to treat early airway cancers or remove larger tumors from the airway. We have also been working to bring in new therapies for advanced COPD. ! What areas of research are you involved in? My research interests are focused in understanding how patients get lung cancer and on developing local therapies for the disease. In collaboration with other researchers here at the University of Vermont and Massachusetts General Hospital, we analyze CT scans and study the genetics of tumors to understand the relationship between diseases such as emphysema and lung cancer. INTERESTED IN VOLUNTEERING? Things to know.: 1) The Vermont Lung Center staff is responsible for making sure you know what is expected of you in regards to the study. ! 2) Once the study is explained to you, you will be asked to read and sign an“Informed Consent”. This form is designed to explain everything you need to know about the study. ! 3) Studies may be therapeutic (involving observation of lung function). However The Vermont Lung Center can make no claims that your involvement in a research study will improve your condition. ! 4) Compensation may or may not be provided to you for your involvement in a study. If compensation is provided, it is meant to cover your time and expenses incurred-it does not constitute employment. ! If you are interested in finding out more about volunteering for a research study, please call us at (802) 847-2193 WWW.VERMONTLUNG.ORG ONGOING STUDIES AT THE VERMONT LUNG CENTER ASTHMA Asthma Patient Registry (APR) Primary Investigator: Charles Irvin, Ph.D. Coordinator: Kathleen Dwinell Who: Anyone with a physician diagnosis of asthma What: 1 visit lasting approximately 30 minutes Compensation: none ! LASST (Long-acting Beta Agonist Step Down Study) Primary Investigator: Charles Irvin, Ph.D. Coordinator: Stephanie Burns Who: Asthmatics ages 12 and older What: 11 visits Compensation: $75 per visit ! SAPS (Smoking Asthmatics Cohort Study) Primary Investigator: Charles Irvin, Ph.D. Coordinator: Stephanie Burns Who: Asthmatics ages 18 to 50 who smoke What: 2 visits Compensation: up to $175 ! CPAP (Effect of Positive Airway Pressure on Airway Reactivity in Patients with Asthma) Primary Investigator: Charles Irvin, Ph.D. Coordinator: Stephanie Burns Who: Asthmatics ages 15-60 What: 6 visits Compensation: up to $600 ! Epithelial Duox1, IL-33, and Allergic Inflammation Primary Investigator: Anne Dixon, M.D. Coordinator: Meena Subramanian Who: Asthmatics and Non-Asthmatics ages 18 - 65 What: 1 visit Compensation: $25 ! Assessing the Effects of Lung Volume and Time on Airway Responsiveness in Asthmatic Subjects Primary Investigator: Jason Bates, Ph.D. Coordinator: Meena Subramanian Who: Asthmatics and Non-Asthmatics ages 18 - 65 What: 3 visits Compensation: $25 per visit ! Non-invasive Detention of Airway Injury Associated with Airway Closure in Asthmatic Subjects Primary Investigator: David Kaminsky, M.D. Coordinator: Meena Subramanian Who: Moderate to Severe Asthmatics ages 18 and older What: 5 visits Compensation: $25 per visit ! IDIOPATHIC PULMONARY FIBROSIS (IPF) A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients with Idiopathic Pulmonary Fibrosis Primary Investigator: Gerald Davis, M.D. Coordinator: Patricia Lutton Who: People age 40 and over with IPF What: Up to 34 visits over a 2 year period Compensation: Travel over 100+ miles ! A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis Primary Investigator: Yolanda Mageto, M.D. Coordinator: Patricia Lutton What: Up to 38 visits over a 2 year period Compensation: Up to $3800. ! Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis. A Multi-center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of the Safety and Efficacy of BMS-986020 in Subjects with IPF FibrosisPrimary Investigator: Yolanda Mageto, M.D. Coordinator: Patricia Lutton Who: People age 40 and older with IPF WINTER 2014 What 14 visits over a period of 30 weeks Compensation $1025-$1275 ! CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Forest: A 52-week, Double-Blind, Randomized, PlaceboControlled, Parallel-Group Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Treated with a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS) Primary Investigator: Anne Dixon, M.D. Coordinator: Meena Subramanian Who: People 40 years and older with COPD What: 8 visits over 1 year Compensation: Up to $2000. Advair 250/50 or Symbicort 160/4.5 and Albuterol provided. ! Study of the Effects of Education on Patients with COPD Primary Investigator: David Kaminsky, M.D. Coordinator: Joan Lippmann Who: People 40 years and older with COPD What: 7 visits over 12 weeks Compensation: 40 per visit ! PULMONARY ARTERIAL HYPERTENSION Changes in the Diffusion Capacity for Carbon Monoxide (DLCO) in Response to Vasodilator Therapy in Patients with Pulmonary Arterial Hypertension Primary Investigator: Sanjiva Lutchmedial, M.D. Coordinator: Stephanie Burns Who: Patients with Pulmonary Arterial Hypertension What: 2 visits Compensation: None ! CYSTIC FIBROSIS A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with CF Primary Investigator: Laurie Leclair, M.D., Thomas Lahiri, M.D. Coordinator: Joan Lippmann Who: People with Cystic Fibrosis What: 9 visits over 8 month period Compensation: Up to $675 ! INTENSIVE CARE UNIT Pharmaconutrients as Therapies for Critical Illness: Zinc in Severe Sepsis Primary Investigator: Renee Stapleton, M.D. PhD Coordinator: Sara Ardren Who: Critically ill patients with severe sepsis and requiring mechanical ventilation. What: One week of IV infusions of zinc or placebo three times a day. Compensation: None ! A Randomized Double-Blind Placebo-Controlled Trial of Ganciclovir/Valganciclovir for Prevention of Cytomegalovirus Reactivation in Acute Injury of the Lung and Respiratory Failure (GRAIL) Primary Investigator: Polly Parsons, M.D., Renee Stapleton, M.D., PhD Coordinator: Sara Ardren Who: Patients who are critically ill and have acute lung injury (ALI) or respiratory failure. What: Enrolled participants will receive an antiviral medication called ganciclovir or a placebo, either through an IV or orally for 14-28 days. Compensation: None ! Telemedicine as a Tool for Family Conferences in Critically ill Patients with High Risk of Imminent Death – Part 2 Primary Investigator: Prema Menon, M.D. Coordinator: Sara Ardren Who: Patients who are critically ill, at increased risk of death and being considered for transfer to FAHC for further treatment. What: Family members will participate in a conference with medical personnel from FAHC prior to the patient’s transfer to evaluate the delivery of information via telemedicine (video conference). Compensation: None WWW.VERMONTLUNG.ORG ! Non-‐Profit Org. INVESTOR NEWSLETTER ISSUE N°3 The Vermont Lung Center The University of Vermont Medical Of;ice Bldg., Suite 305 792 College Parkway Colchester VT 05446 U.S. Postage PAID Permit No. 143 Burlington, VT WINTER 2014 The Vermont Lung Center is affiliated with the following organizations: What is COPD? Anne Dixon, MD COPD stands for chronic obstructive pulmonary disease. It is a disease that makes it The Vermont Lung Center is hard to breathe, and can get worse over time. Over 20 million Americans are thought to suffer with COPD, and it is the third leading cause of death in the U.S. ! supported in part by: ! ! COPD is a progressive and often debilitating disease. Long term smoking –the most common cause of the disease- is responsible for 80-90% of cases. Other risk factors include genetic factors, second hand smoke, air pollution and exposure to occupational dusts and chemical. ! ! COPD causes narrowing of the bronchial tubes or airways that allow air to get into the lungs. This makes it harder for air to get in and out of the lungs. It also causes destruction of the air sacs at the end of the bronchial tubes. These air sacs normally allow oxygen to get into the blood, and carbon dioxide to get out of the blood. Destruction of these air sacs in COPD makes it more difficult for oxygen to get in and carbon dioxide to get out of the body. ! COPD symptoms include shortness of breath, chronic coughing, an increased effort to breathe and increased sputum production. These are everyday symptoms for people who suffer with COPD. From time to time people with COPD may experience sudden worsening of their symptoms, this is often caused by an infection and is called a “COPD exacerbation”. These COPD exacerbations can be quite severe and may need to be treated in hospital. ! The Vermont Lung Center currently is investigating a treatment to prevent COPD exacerbations, for people with COPD who have had two or more exacerbations in the past 12 months. This is an important study, as COPD exacerbations are a serious problem for people with this disease. If you would like to find out more about this study, please contact us. WWW.VERMONTLUNG.ORG