Metformin IN Asthma for Overweight and Obese Individuals (MINA)

Phase 2

Recruiting

• Conditions: Asthma; Overweight and Obesity; Asthma Chronic
• Interventions: Drug: Metformin hydrochloride extended-release tablets; Drug: Visually identical placebo Metformin hydrochloride extended-release tablets

• Registration Number: NCT06273072
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-22
• Study Start: 2024-12-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-09-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin hydrochloride extended-release tablets	Metformin hydrochloride extended-release tablets	Metformin hydrochloride extended-release tablets 2000 mg once daily
Visually identical placebo tablets	Visually identical placebo Metformin hydrochloride extended-release tablets	Placebo tablet once daily

Primary Outcome Measures

Name	Time	Method
Adherence to study drug	Baseline to week 24	Adherence will be measured by pill count
Number of completed telemedicine visits	Baseline to week 24	Number of participants completing at least 3 out of the 4 monitoring telemedicine visits
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 Outcome Measures

Name	Time	Method
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
Change in Asthma exacerbations rate	Baseline to week 24	Change in (annualized) asthma exacerbations rate at week 24
Fractional exhaled nitric oxide (FeNO)	Baseline to week 24	Difference in FeNO between baseline and 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
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

Trial Locations

Locations (2)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States