Using metformin to improve asthma control in overweight and obese adults

Metformin IN Asthma for Overweight and Obese Individuals (MINA)

This study is testing if the diabetes drug metformin can help overweight or obese adults with asthma feel better and manage their symptoms more effectively.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT06273072 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, placebo-controlled pilot study investigating the effects of metformin on asthma control in overweight or obese adults who have poorly managed asthma despite using inhaled corticosteroids. Participants will be randomly assigned to receive either metformin or a placebo for six months, with regular telemedicine visits to monitor side effects and adherence. Asthma outcomes will be assessed at the start of the trial and again at three and six months to evaluate the feasibility of conducting a larger multi-center trial in the future.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have physician-diagnosed asthma that is not well-controlled and have a body mass index of 25 kg/m² or higher.

Not a fit: Patients with major cardiovascular disease, other chronic lung diseases, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for overweight and obese individuals struggling to control their asthma.

How similar studies have performed: While the use of metformin for asthma is a novel approach, previous studies have explored its effects in other conditions, indicating potential for success.

Eligibility criteria

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)

Where this trial is running

Baltimore, Maryland and 1 other locations

• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• Baylor College of Medicine — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Meredith C McCormack, M.D., M.H.S. — Johns Hopkins University
• Study coordinator: Rachelle Koehl, M.S.

Conditions Asthma; Asthma Chronic; Overweight and Obesity