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 |