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WINTER 2014
T h e Spirog ram
What is going on with E-Cigarettes?
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CONTRIBUTORS
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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
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STEPHANIE BURNS
JOAN LIPPMANN
PATTI LUTTON
MEENA SUBRAMANIAN
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INSIDE THIS
ISSUE:
E-Cigarettes
1
New Faculty Interview
2
Ongoing Studies
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COPD
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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.
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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.
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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.
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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.
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WINTER 2014
Interview with New Faculty Member
C. Matthew Kinsey, MD MPH
Where did you grow up?
teachers.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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.
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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
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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
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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
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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
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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
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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
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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.
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supported in part by:
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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.
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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.
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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.
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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.
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