University of Vermont

College of Medicine

Vermont Lung Center

Clinical Trials

 

Every medicine you take was at one time considered an investigational drug. Dozens, sometimes hundreds, of volunteers test the safety and efficacy of new medicines before the drug comes on the market. As a research volunteer, you become an important part of a process that may help people improve their medical condition. The Vermont Lung Center is involved in several studies at all times. At the Vermont Lung Center, we are running several studies in Asthma, Chronic Obstructive Pulmonary Disease (COPD), Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, and studies conducted in the Intensive Care Unit, of The University of Vermont Medical Center. Some may involve investigational drugs, others may be looking at the physiology of a certain condition. Before any clinical study gets underway, it must first be approved by the Institutional Review Board at the University of Vermont. The IRB is a multi-disciplinary group of professionals who review study protocols and any materials that will be used to recruit subjects.

Please find our current studies listed below. If you would like more information about clinical trials or participation in a clinical trial at the VLC, please call the Clinical Trials Office at (802) 847-2193. Vermont Lung Center Clinical Offices are located at 792 College Parkway, Medical Office Building, Suite 305, Colchester, VT  05446

 

Asthma Clinical Studies

Idiopathic Pulmonary Fibrosis Studies

Chronic Obstructive Pulmonary Disease Studies

Cystic Fibrosis Studies

Studies Conducted in the Intensive Care Unit

Cancer Survivor Studies

Pulmonary Hypertension Studies

Asthma

 

Status: Active - Recruiting
Asthma Patient Registry (APR)
Primary Invesitgator: Charles Irvin, Ph.D., Director, Vermont Lung Center
Coordinator: Kathleen Dwinell
Who: Anyone with a physician diagnosis of asthma
What: 1 visit lasting approximately 30 minutes
Compensation: None
Status: Active - Recruiting
SAPS (Smoking Asthmatics Cohort Study)
Primary Invesitgator: Charles Irvin, Ph.D., Director, Vermont Lung Center
Coordinator: Stephanie Burns
Who: Asthmatics ages 18-50 who smoke
What: 2 visits
Compensation: up to $175
Status: Active - Recruiting
Study of Changes in Allergic Inflammation and Airway Remodeling During Bariatric Surgery
Primary Investigator: Anne Dixon, M.D.
Coordinator: Stephanie Burns
Who: Asthmatics ages 18 and older having bariatric surgery 
What: 2 visits
Compensation: $25 per visit
Status: Active - Recruiting
Epithelial Duox1, IL-33, and Allergic Inflammation
Primary Invesitgator: Anne Dixon, M.D.
Coordinator: Meena Subramanian
Who: Healthy Volunteers ages 18-65
What: 1 visit
Compensation: $50
Status: Active - Recruiting
PFIZER - Biomarkers In Uncontrolled Asthma
Primary Invesitgator: Anne Dixon, M.D.
Coordinator: Meena Subramanian
Who: Asthmatics using Advair or Symbicort ages 15-70
What: 2 visit
Compensation: $250

 

   
Status: Active - Recruiting
Endotyping Asthma Phenotypes
Primary Invesitgator: Anne Dixon, M.D.
Coordinator: Meena Subramanian
Who: Asthmatics ages 18-65 with BMI greater than 30
What: 1 visit
Compensation: up to $200

 

 

Status: Active - Recruiting
Soluble Interleukin - 6 Receptor Production in Asthma
Primary Invesitgator: Mercedes Rincon Ph.D.
Coordinator: Meena Subramanian
Who: Asthmatics ages 18-65
What: 2 visits
Compensation: up to $200

 

Idiopathic Pulmonary Fibrosis (IPF)

Status: Active - Recruiting
RIFF: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients with Idiopathic Pulmonary  Fibrosis
Primary Invesitgator: Yolanda Mageto, M.D., MPH
Coordinator: Stephanie Burns
Who: People age 40 and over, with IPF
What: Up to 34 visits over a 2 year period
Compensation: Reimbursement for travel over 100 miles

 

Status: Active - Recruiting
Fibrogen - 067: A Phase 2, Randomized, Double-Blind, placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis
Primary Invesitgator: Yolanda Mageto, M.D., MPH
Coordinator: Stephanie Burns
Who: People age 40-80 inclusive with IPF
What: Up to 38 visits over a 2 year period
Compensation: up to $3,800

 

Status: Active - Recruiting
BMS: Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis.  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Efficacy of BMS-986020 in subjects with Idiopathic Pulmonary Fibrosis
Primary Invesitgator: Yolanda Mageto, M.D., MPH
Coordinator: Stephanie Burns
Who: People age 40 and over, with IPF
What: Up 14 visits for a total of 30 weeks
Compensation: up to $1,025 - $1,275

 

Status: Active - Recruiting
PIPF-031: A Treatment Protocol To Allow Patients in The U.S. with Idiopathic Pulmonary Fibrosis Access to Pirfenidone
Primary Invesitgator: Yolanda Mageto, M.D., MPH
Coordinator: Stephanie Burns
Who: People with IPF
What: 18 - 24 months of Treatment or until Pirfenidone becomes commercially available in the U.S.

 

Chronic Obstructive Pulmonary Disease (COPD)

 

Status: Active - Recruiting
Forest: A 52-week, Double-Blind, Randomized, Placebo-Controlled, 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 Invesitgator: Anne Dixon, M.D.
Coordinator: Meena Subramanian
Who: People with COPD ages 40 and over
What: 8 visits over 1 year
Compensation: up to $2000, Advair250/50 or Symbicort 160/4.5 and Albuterol provided
Status: Active - Recruiting
Study of the Effects of Education on Patients with COPD
Primary Invesitgator: David Kaminsky, M.D.
Coordinator: Joan Lippmann
Who: People 40 years and older with COPD
What: 7 visits over 12 weeks
 
Status: Active - Recruiting
Voucher-based incentives to promote smoking abstinence among patients with chronic obstructive pulmonary disease
Primary Invesitgator: Stacey Sigmon, Ph.D.
Co-Investigators: Anne Dixon, M.D., Charlotte Teneback, M.D.
Coordinator: Mollie Patrick
Who: Smokers who are over age 35 and have a diagnosis of COPD
What: 2-week study with brief daily visits for monitoring smoking status
Compensation: Up to $587.50

 

Cystic Fibrosis

 

Status: Active - Recruiting
A Phase 2, Multicenter, Double­Blinded, Placebo­Controlled, 3-Part Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX­661 Monotherapy and VX­661/VX­770 Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Primary Invesitgators: Laurie Leclair, M.D./Thomas Lahiri, M.D.
Coordinator: Joan Lippmann
Who: People with Cystic Fibrosis
What: 9 visits over 2.5 month period including 28 days treatment
Compensation: up to $1150

 

Intensive Care Unit

 

Status: Active - Recruiting
Pharmaconutrients as Therapies for Critical Illness: Zinc in Severe Sepsis
The purpose of this study is to examine how patients with severe sepsis (sepsis with organ failure) metabolize zinc and whether providing zinc intravenously three times a day for one week provides any benefit.
Primary Invesitgator: Renee Stapleton, M.D., Ph.D.
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
Status: Active - Recruiting
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)
The purpose of the GRAIL study is to determine if giving an antiviral medication will inhibit reactivation of cytomegalovirus (CMV) and reduce lung inflammation.
Primary Invesitgator: Polly Parsons, M.D., with Renee Stapleton, M.D., Ph.D.
Coordinator: Sara Ardren
Who: Patients who are critically ill and have acute lung injury (ALI) or respiratory failure. ALI is a severe form of lung failure that is life-threatening and associated with high levels of inflammation.
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
Status: Active - Recruiting
Changing the Paradigm of In-Hospital CPR with Informed Assent: A Pilot Randomized Controlled Trial
The purpose of this study is to find a new way to inform patients with advanced chronic illness about CPR and discuss its use for them if their heart or lungs were to stop while they were I the hospital.
Primary Invesitgator: Renee Stapleton, M.D., Ph.D.
Coordinator: Sara Ardren
Who: Individuals with oxygen-dependent COPD or advanced malignancy who are felt to have a life expectancy of less than two years.
What: Patients with a chronic illness and up to two of their family members will receive information about CPR in one of two ways—either through a discussion with two doctors or through reading an information brochure created for this study.
Compensation: none

 

Satatus: Active - Recruiting
Telemedicine as a Tool for Family Conferences in Critically ill Patients with High Risk of Imminent Death-Part 2
Primary Invesitgator: Prema Menon, M.D.
Coordinator: Sara Ardren
Who: Patients who are critically ill, at increased risk of death and being considered for transfer to UVM Medical Center for further treatment.
What: Family members will participate in a conference with medical personnel from The University of Vermont Medical Center prior to the patient's transfer to evaluate the delivery of information via telemedicine (video conference).
Compensation: none

 

Cancer Survivor Studies

 

Status: Active - Recruiting
Predictors of Dyspnea/Fatigue Syndrome in Breast Cancer Survivors Before and After an Exercise Intervention
Study Description: The purpose of this study is to determine why fatigue and shortness of breath are such common side effects of cancer therapies and how fatigue and shortness of breath symptoms change after an exercise program.
Primary Invesitgators: Benjamin Suratt, MD; Kim Dittus, MD, PhD; Deboarah Rubin, MD; David Kaminsky, MD; Susan Lakoski, MD, MS
Coordinator: Karen Wilson, CCRP
Who: Adult breast cancer patients initiating chemotherapy for the first time
What: Enrolled participants will be randomized to engage in supervised exercise either during the time they are receiving chemotherapy or after they have completed chemotherapy.
Compensation: $0, pedometer

 

Pulmonary Arterial Hypertension

 

Status: Active - Recruiting
Changes in the Diffusion Capacity for Carbon Monoxide (DLCO) in Response to Vasodilator Therapy in Patients with Pulmonary Arterial Hypertension
Primary Invesitgator: Sanjiva Lutchmedial, M.D.
Coordinator: Stephanie Burns
Who: Patients with Pulmonary Arterial Hypertension
What: 3 visits
Compensation: none

Last modified November 21 2014 02:49 PM