Asthma Clinical Trial
Official title:
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2028 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Baylor College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Temple University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of completed telemedicine visits | Number of participants completing at least 3 out of the 4 monitoring telemedicine visits | Baseline to week 24 | |
Primary | Adherence to study drug | Adherence will be measured by pill count | Baseline to week 24 | |
Primary | Retention rate | Investigators will collect data on the number of subjects screened, randomized, and complete the final in-person visit | Baseline to week 24 | |
Secondary | 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 | |
Secondary | Change in Asthma exacerbations rate | Change in (annualized) asthma exacerbations rate at week 24 | Baseline to week 24 | |
Secondary | Pre-bronchodilator lung function | Difference in volume of air exhaled in the first second during spirometry (FEV1) at week 24 | Baseline to week 24 | |
Secondary | Fractional exhaled nitric oxide (FeNO) | Difference in FeNO between baseline and week 24 | Baseline to week 24 | |
Secondary | 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 |
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