Asthma, Asthma Chronic, Overweight and Obesity
Conditions
Brief summary
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
Detailed description
This is a randomized, placebo-controlled, parallel-arm pilot clinical trial. Adult participants who are overweight or obese and have not well-controlled asthma despite use of an inhaled corticosteroid will be randomized to metformin, an FDA-approved medication for the treatment of type 2 diabetes mellitus, or to placebo, to be taken daily for a total duration of six months. Recruitment will occur at two sites in the United States. Randomized participants will have regular telemedicine visits to assess side effects and adherence. Additionally, participants will have a measurement of asthma outcomes at randomization and at 3 and 6 months after randomization. The purpose of this study is to determine feasibility to inform a future multi-center clinical trial of metformin in this population.
Interventions
titrated to 2000 mg once daily
DRUGVisually identical placebo Metformin hydrochloride extended-release tablets
placebo
Sponsors
Baylor College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Temple University
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Physician-diagnosed asthma on maintenance therapy * Not well-controlled asthma (ACT score \<20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months) * Overweight or obesity: Body mass index ≥25kg/m2 * Adult: Age ≥18
Exclusion criteria
* Currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding * Major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months * Other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis * Active smoking or former smoker with ≥20 pack-year smoking history * Chronic kidney disease: estimated glomerular filtration rate ≤60 mL/min/1.73 m2 * Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man * Liver disease: elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x the upper limit of normal or prior diagnosis of liver disease * Anemia: hemoglobin \< 13 g/dl in males and hemoglobin \< 11 g/dl in females * Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss * Diabetes (Hemoglobin A1C ≥ 6.5% or taking metformin or other medications used to treat diabetes) * Participation in any other clinical trial (observational studies are permitted)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of completed telemedicine visits | Baseline to week 24 | Number of participants completing at least 3 out of the 4 monitoring telemedicine visits |
| Adherence to study drug | Baseline to week 24 | Adherence will be measured by pill count |
| Retention rate | Baseline to week 24 | Investigators will collect data on the number of subjects screened, randomized, and complete the final in-person visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fractional exhaled nitric oxide (FeNO) | Baseline to week 24 | Difference in FeNO between baseline and week 24 |
| Asthma control as assessed by the Asthma Control Test (ACT) score | Baseline to week 24 | Difference in Asthma Control Test (ACT) score at week 24; range is from 5-25 with higher being better asthma control |
| Airways hyperresponsiveness | Baseline to week 24 | Difference in cumulative dose of mannitol required to precipitate a significant decrement in FEV1 between baseline at week 24 |
| Change in Asthma exacerbations rate | Baseline to week 24 | Change in (annualized) asthma exacerbations rate at week 24 |
| Pre-bronchodilator lung function | Baseline to week 24 | Difference in volume of air exhaled in the first second during spirometry (FEV1) at week 24 |
Countries
United States
Contacts
Primary ContactRachelle Koehl, M.S.
Backup ContactMeredith C McCormack, M.D., M.H.S.
Outcome results
None listed