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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma; Overweight and Obesity; Asthma Chronic
• Intervention / Treatment: Drug: Metformin hydrochloride extended-release tablets; Drug: Visually identical placebo Metformin hydrochloride extended-release tablets

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rachelle Koehl, M.S.; Phone Number: 410-955-1530; Email: rkoehl1@jhmi.edu
• Study Contact Backup: Name: Meredith C McCormack, M.D., M.H.S.; Phone Number: 410-550-6205; Email: mmccor16@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin hydrochloride extended-release tablets; Metformin hydrochloride extended-release tablets 2000 mg once daily	Drug: Metformin hydrochloride extended-release tablets; titrated to 2000 mg once daily
Placebo Comparator: Visually identical placebo tablets; Placebo tablet once daily	Drug: Visually identical placebo Metformin hydrochloride extended-release tablets; placebo

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
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
Pre-bronchodilator lung function	Difference in volume of air exhaled in the first second during spirometry (FEV1) at week 24	Baseline to week 24
Fractional exhaled nitric oxide (FeNO)	Difference in FeNO between baseline and week 24	Baseline to week 24
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
Change in Asthma exacerbations rate	Change in (annualized) asthma exacerbations rate at week 24	Baseline to week 24

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Baylor College of Medicine; National Heart, Lung, and Blood Institute (NHLBI); Temple University
• Investigators: Principal Investigator: Meredith C McCormack, M.D., M.H.S., Johns Hopkins University; Principal Investigator: Tianshi D Wu, M.D., M.H.S., Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Overnutrition; Nutrition Disorders; Body Weight; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: IRB00409080; R34HL166438-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No