NCT06273072

Metformin IN Asthma for Overweight and Obese Individuals (MINA)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• Asthma Chronic
• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	Metformin hydrochloride extended-release tablets	titrated to 2000 mg once daily
DRUG	Visually identical placebo Metformin hydrochloride extended-release tablets	placebo

Timeline

• Start date: 2024-12-09
• Primary completion: 2026-09-30
• Completion: 2028-12-31
• First posted: 2024-02-22
• Last updated: 2026-01-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study