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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL166438-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Temple University | OTHER |
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This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin hydrochloride extended-release tablets | Active Comparator | Metformin hydrochloride extended-release tablets 2000 mg once daily |
|
| Visually identical placebo tablets | Placebo Comparator | Placebo tablet once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin hydrochloride extended-release tablets | Drug | titrated to 2000 mg once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of completed telemedicine visits | Number of participants completing at least 3 out of the 4 monitoring telemedicine visits | Baseline to week 24 |
| Adherence to study drug | Adherence will be measured by pill count | Baseline to week 24 |
| Retention rate | Investigators will collect data on the number of subjects screened, randomized, and complete the final in-person visit | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control as assessed by the Asthma Control Test (ACT) score | Difference in Asthma Control Test (ACT) score at week 24; range is from 5-25 with higher being better asthma control | Baseline to week 24 |
| Change in Asthma exacerbations rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachelle Koehl, M.S. | Contact | 410-955-1530 | rkoehl1@jhmi.edu | |
| Meredith C McCormack, M.D., M.H.S. | Contact | 410-550-6205 | mmccor16@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Meredith C McCormack, M.D., M.H.S. | Johns Hopkins University | Principal Investigator |
| Tianshi D Wu, M.D., M.H.S. | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Visually identical placebo Metformin hydrochloride extended-release tablets | Drug | placebo |
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Change in (annualized) asthma exacerbations rate at week 24
| Baseline to week 24 |
| Pre-bronchodilator lung function | Difference in volume of air exhaled in the first second during spirometry (FEV1) at week 24 | Baseline to week 24 |
| Fractional exhaled nitric oxide (FeNO) | Difference in FeNO between baseline and week 24 | Baseline to week 24 |
| Airways hyperresponsiveness | Difference in cumulative dose of mannitol required to precipitate a significant decrement in FEV1 between baseline at week 24 | Baseline to week 24 |
| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |