Metformin IN Asthma for Overweight and Obese Individuals (MINA)

Johns Hopkins University

Status and phase: Enrolling; Phase 2

Conditions: Asthma; Overweight and Obesity; Asthma Chronic

Treatments: Drug: Metformin hydrochloride extended-release tablets; Drug: Visually identical placebo Metformin hydrochloride extended-release tablets

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06273072

IRB00409080

R34HL166438-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Metformin hydrochloride extended-release tablets

Active Comparator group

Description:

Metformin hydrochloride extended-release tablets 2000 mg once daily

Treatment:

Drug: Metformin hydrochloride extended-release tablets

Visually identical placebo tablets

Placebo Comparator group

Description:

Placebo tablet once daily

Treatment:

Drug: Visually identical placebo Metformin hydrochloride extended-release tablets