Asthma Clinical Trials

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: Maya Horton  Maya.Horton@uvmhealth.org  802-847-9803

Who:

  • Asthmatics and Healthy subjects
  • Ages 18-75 years
  • Diagnosed with asthma in childhood (under 18 yrs old)
  • BMI 18.5- 24.9 OR BMI >30kg
  • Chronic Nasal symptoms (ex. Runny nose, facial pain/pressure, nasal blockage)
  • Prescribed ICS, or Rescue inhaler+singulair, no use of nasal steroids, systemic steroids, or biologics in the last 4 weeks
  • Less than 20 pack year smoking history, no smoking in last 6 months
  • Allergy to dust mites, IgE 100 or higher (both determined at screening visit)
  • Physiological Evidence of Asthma (PC20 to methacholine < 16mg/ml or BD response

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: Cory Raymond  Cory.Raymond@uvmhealth.org  802-847-8839

Who:

  • Age 18 - 65 years
  • BMI > 30
  • Diagnosed with asthma
  • Non-smoker or smokes less than 20 packs/year
  • IgE less than 100

What: 3-4 visits

Compensation: Up to $300

 

STATUS: Active - Recruiting

AstraZeneca RCT for triple therapy MDI (ICS/LAMA/LABA – budesonide, glycopyronium, formoterol fumarate) for poorly controlled asthmatics. (KALOS)

Primary Investigator: Anne Dixon, MA, BM, BCh
Coordinator: Olivia Johnson  Olivia.Johnson@uvmhealth.org  802-847-2160

Who:

  • Age 18-20
  • Diagnosed w/ asthma at least 1 year prior, without other chronic lung disease
  • Poorly controlled asthma
  • Documented Reversibility greater than 12% and 200ml
  • Prescribed ICS/LABA
  • Not taking LAMA, biologics, or chronic corticosteroids
  • Not currently smoking, or less than 10 pack year history
  • BMI of 40+ kg/m2

 

STATUS: Active - Recruiting

Virtual interventional study aiming to determine whether a participating in a telehealth program will increase medication adherence. (MATCH)
Primary Investigator: Anne Dixon, MA, BM, BCh
Coordinator: Maya Horton  Maya.Horton@uvmhealth.org  802-847-9803

Who:

  • Age 12 through 35 years
  • Physician diagnosed asthma (without any other co-morbid pulmonary disease)
  • Prescribed ICS for at least 3 months prior to screening
  • Current use of albuterol metered dose inhaler (MDI) for rescue
  • Uncontrolled/Symptomatic asthma in the past 4 weeks (ex. daytime symptoms of asthma more than twice per week, any night awakening due to asthma, rescue inhaler use more than twice per week, any activity limitation due to asthma)
  • Has Smartphone and access to reliable WiFi service
  • Not currently enrolled in any other interventional research studies

 

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: Olivia Johnson  Olivia.Johnson@uvmhealth.org  802-847-2160

Who:

  • Age 18+
  • BMI of 30+ kg/m2
  • Diagnosed with asthma without any other chronic lung disease
  • Poorly controlled asthma including rescue inhaler 2+ times per week, nocturnal asthma awakenings 1+ times per week, or prednisone or ED/hospital admission for asthma in last 6 months.
  • Not currently smoking or less than 20 pack/year history
  • Prescribed ICS

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: Maya Horton  Maya.Horton@uvmhealth.org  802-847-9803

Who:

  • Ages > 40 years
  • Current or past smoker of at least 10 pack per year
  • Diagnosis of COPD and Chronic Bronchitis
  • Hospitalized with COPD Exacerbation in past year, or respiratory complications associated with COVID
  • Current meds include LAMA, LABA/LAMA, or ICS/LABA
  • Not currently prescribed chronic Zithromax or Daliresp (chronic = 30+ days)
  • No contraindication for Daliresp or Roflumilast
  • No moderate to severe liver impairment

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

 

 

Cystic Fibrosis Clinical Trials

 

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.

 

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 - Recruiting

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  Julie.Sweet@uvmhealth.org  802-847-7958

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  Julie.Sweet@uvmhealth.org  802-847-7958

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  Julie.Sweet@uvmhealth.org  802-847-7958

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  Julie.Sweet@uvmhealth.org  802-847-7958

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

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 - Recruiting

(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 

Phase 3 superiority randomized trial of Macitenan 75mg vs 10mg. (UNISUS)


Primary Investigator: Jessica Badlam, MD
Coordinator: Caitlin McCaffrey  Caitlin.McCaffrey@uvmhealth.org  802-847-2193

Eligibility Criteria:

• Age 18+
• Symptomatic PAH
• If on PAH therapies, must be stable for prior 3 mos
• Not at high risk for heart failure
• No moderate or severe obstructive/restrictive lung disease
• Not currently prescribed chronic Zithromax or Daliresp (chronic = 30+ days)
• Cannot have participated in cardiopulmonary rehab in prior 3 mos

 

STATUS: Active - Recruiting

Phase 3 randomized trial of ralinepag 50mcg vs placebo when added to PAH standard of care or PAH specific oral therapy in patients w/ diagnosis of WHO Group 1 PAH. (301/303)

Primary Investigator: Jessica Badlam, MD
Coordinator: Caitlin McCaffrey  Caitlin.McCaffrey@uvmhealth.org  802-847-2193
Eligibility Criteria:

• Age 18+
• Symptomic PAH
• If on oral PAH therapies, must be stable dose
• FEV1 and TLC >60% Predicted
• No history of thromboembolic disease (determined by V/Q lung scan)
• No ongoing/clinically significant diagnosis of sleep apnea
• No active HBV or HCV infection
• No chronic renal insufficiency or dialysis
• Cannot have participated in cardiopulmonary rehab in prior 3 mos

 

OTHER STUDIES

STATUS: Active - Recruiting

Lung Health Cohort: 5-year observational cohort study, recruiting participants at peak lung health and studying what factors lead to changes in lung health over time.
Coordinator: Cory Raymond  Cory.Raymond@uvmhealth.org  802-847-8839
Eligibility Criteria:

• 25-35 Years Old
• No pulmonary or cardiovascular disease (mild asthma is ok)

 

 

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.