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

STATUS: Active - Recruiting
Effect of BMI on Allergic Airway Disease (EBAD)
Primary Invesitgator: Anne Dixon, MA, BM, BCh
Coordinator: Olivia Johnson
Who: Ages 18 and above, Asthmatics and non-asthmatics enrolled in the bariatric surgery program
What: 9 visits
Compensation: up to $1000



STATUS: Active - Recruiting

Pilot of Lifestyle and Asthma Intervention (PLAN)

This research is a pilot study to investigate an internet-based weight loss program as a way to help people with asthma lose weight.

Primary Investigator: Anne Dixon, MA, BM, BCh
Coordinator: Olivia Johnson
Who: Ages > 18 years of age; BMI > 30kg
What: 6 visits,  with one phone call visit
Compensation: Participants will be provided with a laptop to keep at end of study; mileage reimbursement based on the standard UVM mileage rate.



STATUS: Active - Recruiting
S-glutathionylation Chemistry, Metabolism and Allergic Asthma (GLUT)
The purpose of this study is to identify chemical and metabolic pathways in nasal cells that are abnormal in people with asthma compared to non-asthmatics, and if they are altered in people of different weights; as these pathways might be targets for treating with new medications.
Primary Invesitgator: Anne Dixon, MA, BM, BCh
Coordinator: Erika Gonyaw
Who: Asthmatics and Healthy subjects, Ages 18-75 years, BMI >30kg
What:4 - 5 Visits
Compensation: up to $525

STATUS: Active - Recruiting

Asthma BMI Baseline Study (ABBS)
The purpose of this research study is to identify individuals with a BMI of >30 kg and poorly controlled asthma to determine if a population exists in which to run future investigational studies.   
Primary Investigator: Anne Dixon, MA, BM, BCh
Coordinator: Erika Gonyaw
Who: Ages 18 and above; BMI > 30kg
What: 2 visits, over a four week period
Compensation: up to $100

 

Increased Lung Volume as Controller Therapy for Asthma (Controller)

Primary Investigator: Anne Dixon, MA, BM, BCh
Coordinator: Kevin Hodgdon
Who: Asthmatics and non-asthmatics Ages 18 – 65
What: 3-4 visits
Compensation: Up to $300

 

Trial of Roflumilast in Asthma Management (TRIM)
Primary Investigator: Anne Dixon, MA, BM, BCh
Coordinator: Kevin Hodgdon
Who: Ages 18 and above whose asthma is not well controlled and a body mass index (BMI) is greater than 30kg/m2
What: 7 visits
Compensation: up to $350


STATUS: Active - Recruiting

(MIMDA) MitoQ for the treatment of Metabolic Dysfunction in Asthma

A 12-week, randomized, placebo-controlled, double-masked clinical trial in patients with a BMI > 30kg/m2 and poorly controlled asthma.  The intervention drug that is over the counter, is Mitoquinol (MitoQ), anti-oxidant oral supplement.  The primary aim of this pilot study is to determine if (MitoQ) improves airway reactivity in overweight patients with asthma.
Primary Investigator: Anne Dixon, MA, BM, BCh
Coordinator: Erika Gonyaw
Who: Ages > 18 years
What: 5-6 visits

Compensation: up to $550

COPD - Chronic Obstructive Pulmonary Disease

STATUS: Active - Recruiting
(RELIANCE) RofLumilast or Azithromycin to prevent Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Patients recently hospitalized within the past year for a COPD exacerbation, will be treated with a long-term azithromycin or roflumilast. This study will help us determine which medication has better effects and which one is better tolerated in people with COPD.
Primary Investigator: Anne Dixon, MA, BM, BCh
Coordinator: Erika Gonyaw
Who: Ages > 40 years, current or past smoker of at least 10 pack years
What:1 in person visit, 3 month follow up phone call or inter-active web site visits, from 6 months to one year, depending on when you are enrolled in the study.  With decision to opt out of the study at any time.
Compensation: $15 gift card immediately when you enroll in the study and a $10 gift card for answering questions about your health online or in a telephone interview every 3 months

STATUS: Active - Recruiting

Losartan Effects on Emphysema Progression (LEEP)
This research is conducted to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema – a disease of the lungs.
Primary Investigator: David Kaminsky, M.D.
Coordinator: Erika Gonyaw
Who: Ages 40 years and over; Current or former smoker with > 10 pack-year history
What: 7 visits
Compensation: up to $425

- Control Subjects

STATUS: Active - Recruiting
Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects (RESMON)
The purpose of this study is to determine what normal values are while measuring lung function on a new device, and how stable the measurements are over short periods of time.
Primary Investigator: David Kaminsky, M.D.
Coordinator: Chloe Housenger
Who: Healthy volunteers, with no allergies, and never have smoked.  Ages: 41 years and above; BMI < 30kg.
What: 1 two hour visit
Compensation: $25

Cystic Fibrosis

 

STATUS: Active - Recruiting

STOP2-IP-15 
A randomized, controlled, open-label study designed to evaluate the efficacy and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adult patients with CF.  The study will assess the non-inferiority of 10 days versus 14 days treatment duration among early robust responder (ERR) subjects and the superiority of 21 days versus 14 days treatment duration among the subjects who do not meet the definition of ERR (non-ERR; NERR).
Primary Investigator: Charlotte Teneback, MD
Coordinator: Julie Sweet

 

STATUS: Active - Recruiting

SAV005-04 

A Phase III, randomized, double-blind, placebo-controlled study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus lung infection in cystic fibrosis patients.  This study has two periods:
Period 1 will last up to 30 weeks (including Screening) and have 9 visits
Period 2 will last up to 24 weeks and will only have 4 visits.

Primary Investigator: Charlotte Teneback, MD
Coordinator: Julie Sweet

 

Interstitial Lung Disease

STATUS: Active - Recruiting
Celgene CC-90001-IPF-001:  
A Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, With a 28-Week Active Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with
Idiopathic Pulmonary Fibrosis.
This is a research study to see if an experimental drug, CC-90001 helps improve symptoms of Idiopulmonary Fibrosis (IPF). The study also looks at how well CC-90001 is tolerated in terms of side effects. After a screening period, participants will receive either CC-90001 200 mg, CC-90001 400 mg, or a placebo to be taken once daily by mouth for 24 weeks, followed by a 28-week extension phase. The study will include up to 18 visits over a period of 64 weeks.
Primary Investigator: Prema Menon, MD, Ph.D.
Coordinator: Anna Raymond
Who: Ages > 40 Years
What: 18 Visits over a period of 64 weeks
Compensation: up to $1800.00, as well as mileage and hotel for trips > 100 miles.

 

(Galapagos) GLPG1690-CL-304:
A Phase 3, randomized, double-blind, parallel-group, placebo-controlled multicenter study to evaluate the efficacy and
safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis.  
The study looks at whether GLPG1690 can safely inhibit increased autotaxin in the lungs and therefore affect the progression of Idiopathic Pulmonary Fibrosis . The main purpose of this study is to see how GLPG1690 works together with your current standard treatment on your IPF disease in general; and also see how well GLPG1690 is tolerated (for example if you get any side effects while on study drug).
Primary Investigator: Prema Menon, MD, Ph.D.
Coordinator: Anna Raymond
You might receive study drug for 52 weeks or much longer. You will remain in the study until the time all subjects in the study have been in the study for 52 weeks, sometime toward the end of 2021. In the first 52 weeks of study treatment period, you will need to come to the research site 10 times for a study visit. Thereafter, you will need to come to the research site every 12 weeks. Additional costs you may incur for your participation in this study (such as travel costs) will be reimbursed based upon your original receipts.

STATUS: Active - Recruiting

(IPF PRO Registry) Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO), and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype Prospective Outcomes (ILD-PRO) Registry
Primary Investigator: Prema Menon, MD, Ph.D.
Coordinator: Anna Raymond
This study is a registry, it is not a clinical trial. In a registry study we do not intervene in your medical care, but rather collect information about the medical care you receive. The purpose of this registry is to collect information about you from your medical records and from interviews and questionnaires. We will also collect biological samples that will support future research studies.

 

STATUS: Active - Recruiting

(SPRINT) 1199-0324:  Study of pulmonary rehabilitation in patients with Idiopathic Pulmonary Fibrosis (IPF)
This study is being done to see if pulmonary rehabilitation improves the physical activities and quality of life in subjects who have IPF and are taking Ofev®, and if any benefits from the pulmonary rehabilitation last after stopping the pulmonary rehabilitation in subjects with IPF who are taking Ofev®.
Primary Investigator: Prema Menon, MD, Ph.D.
Coordinator: Anna Raymond
 Who: Subjects ages > 40 Years
What: 26 weeks of 8 Visits
Compensation: $800

 

Important Information for Study Participants

The Vermont Lung Center staff is responsible for making sure you understand what is expected of you from the study.

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-who the Principal Investigator is, who the sponsor is, what is being researched, what your compensation is and what to do if you encounter a problem.

Studies may be therapeutic (involving investigational drugs or equipment) or non-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.

Compensation may or may not be provided to you for your involvement in a study. If compensation is provided, it is meant to cover time and expenses incurred while acting as a study subject-it does not constitute employment.