Clinical Trials, Vermont Lung Center, Larner College of Medicine, UVM

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

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.

Asthma

STATUS: Active - Recruiting

Effect of BMI on Allergic Airway Disease (EBAD)

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 and above, Asthmatics and non-asthmatics enrolled in the bariatric surgery program

What: 9 Visits.

Compensation: up to $1000

STATUS: Active - Recruiting

The Gut Microbiome in Obese Non-Allergic Asthma (MONA)

This study will compare how diet and bacteria in the gut affects lung function.

Primary Investigator: Brittany Duchene, MD, Anne Dixon, MD

Coordinator: Olivia Johnson

Who: Ages 18 and older, Asthmatics and Non-Asthmatics, BMI > 30

What: 2 visits between 1-2.5 hours.

Compensation: Up to $100.00

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 Investigator: 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

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

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

Beta-Blocker Use in Patients with Chronic Obstructive Pulmonary Disease (COPD) and Acute

Myocardial Infarction (an Ancillary Study to Beta-Blockers for the Prevention of Acute Exacerbations
of COPD)

The purpose of this observational study is to examine the relationship between beta-blocker
drug use and heart and lung health outcomes after a recent heart attack in patients with
COPD.

Primary Investigator: David Kaminsky, MD

Coordinator: Erika Gonyaw

Who: Ages 35 and older who are admitted to the hospital for an Acute Myocardial Infarction,

undergo a cardiac catheterization and have COPD.

What: One in-person visit while hospitalized and two follow-up phone calls three and six
months after hospital discharge.

Compensation: $25.00 for visit one and $25.00 for each of the two phone calls

Cystic Fibrosis

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.

STATUS: ACTIVE - ENROLLING

A Phase 1b Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety of CB-280 inPatients with Cystic Fibrosis (CX-280-202)

This research study is to learn more about the safety of a drug called CF-280 in people with

Cystic Fibrosis. CB-280 is an investigational drug that is taken by mouth that blocks an enzyme
called arginase, which is thought to play an important role in promoting lung function
infection in CF.

Primary Investigator: Charlotte Teneback, MD

Coordinator: Julie Sweet

Who: 18 years and older, confirmed diagnosis of Cystic Fibrosis, FEV1 40-90%, at least one
positive culture of P. aeruginosa in the last two years.

What: 6 study visits over 56 days. Four of the visits take approximately 3-7 hours and two of
the visits will take about 15 hours.

Compensation: up to $1320.00 for completion of the 6 study visits.

STATUS: Active - Recruiting

Prospective study of peripherally inserted venous catheters in CF patients (PICC CF)

A multi-center study to see whether we can identify important factors which can lead to
complications such as catheter related factors, patient factors and catheter management
factors.

Primary Investigator: Thomas Lahiri, MD

Coordinator: Julie Sweet

Who: Ages 6 and older, undergoing IV antibiotics for a CF pulmonary exacerbation via a PICC
line.

What: Questionnaires at the time of PICC placement, 2 blood draws via the PICC line,
questionnaires every 2-3 days while PICC line is in place.

Compensation: $30 at enrollment and $30 after removal of PICC line

STATUS: Active - Recruiting

A master protocol to test the impact of discontinuing chronic therapies in people with cystic fibrosis
on highly effective CFTR modulator therapy (SIMPLIFY)

The study is being done to test whether or not it is safe to stop taking inhaled hypertonic
saline or Pulmozyme in those people that are also taking Trikafta.

Primary Investigator: Thomas Lahiri, MD

Coordinator: Julie Sweet

Who: Ages 12 and older with Cystic Fibrosis

What: 4 study visits and questionnaires every month for 6 months

Compensation: $90.00 for screening visit, $60.00 for visits 1-3, $15 for a phone call, up to
$132.00 for completion of questionnaires. Up to $30.00 for completion of post study
questionnaires.

STATUS: Active - Recruiting

A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function
in Infants and Young Children (BEGIN)

There are two parts of the study. Part A is to collect health information on infants and young
children before starting treatment with CFTR modulator therapies. Part B is to collect health
information about growth and symptoms related to CF from infants and young children after
starting treatment with a CFTR modulator therapy.

Primary Investigator: Jillian Sullivan, MD

Coordinator: Julie Sweet

Who: Infants to age 5 years, diagnosed with cystic fibrosis, with two well-characterized
mutations in the CFTR gene

What: Part A: 6 visits during routine clinical care appointments over 36 months. Part B: 6 visits
during routine clinical care appointments over 24 months.

Compensation: Between $435.00 and $465.00.

Interstitial Lung Disease

STATUS: Active - Recruiting

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.

STATUS:

(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

Pulmonary Hypertension:

STATUS: Active - Recruiting

A Study Evaluating the Efficacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH
Patients (Advance Outcomes)

This study is to learn more about the study drug Ralinepag in the treatment of Pulmonary
Arterial Hypertension.

Primary Investigator: Jessica Badlam, MD

Coordinator: Kevin Hodgdon

Who: Age 18 and older with Pulmonary Arterial Hypertension

What: Screening visit, Titration period 16 weeks one visit every 4 weeks, optimal dosing
period every 12 weeks.

Compensation: $75.00 for each study visit.

Healthy Individuals:

STATUS: Active - Recruiting

Reactive Oxygen Species ROS I.E. (ROSIE)

This study is to investigate how altered cellular pathways in obesity leads to severe COVID-19.

Primary Investigator: Anne Dixon, MD

Coordinator: Erika Gonyaw

Who: Ages 18 and older, no history of chronic lung disease or allergic rhinitis, BMI 18.5-24.9
and >30

What: 1-3 study visits lasting between 15-60 minutes

Compensation: $50.00 per visit.

Post- COVID Illness:

STATUS: Active - Recruiting

Longitudinal Assessment of Lung Function in COVID-19 Patients

This is a comprehensive study of lung function after having COVID-19 to better understand
how COVID-19 affects the lungs in the long term and provide health care providers guidance
on how to monitor breathing in patients who have recovered from COVID-19

Primary Investigator: David Kaminsky, MD

Coordinator: Olivia Johnson

Who: Ages 18 and over, history of COVID-19 illness

What: 3 study visits over 12 months

Compensation: $95.00 per study visit