Metformin IN Asthma for Overweight and Obese Individuals (MINA)

Asthma Clinical Trial

Official title:

Metformin IN Asthma for Overweight and Obese Individuals (MINA)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06273072
• Other study ID #: IRB00409080
• Secondary ID: R34HL166438-01A1
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Rachelle Koehl, M.S.
• Phone: 410-955-1530
• Email: rkoehl1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2028
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Asthma Chronic
• Overweight
• Overweight and Obesity

Intervention

Drug:
• Metformin hydrochloride extended-release tablets
titrated to 2000 mg once daily
• Visually identical placebo Metformin hydrochloride extended-release tablets
placebo

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Baylor College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Temple University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of completed telemedicine visits	Number of participants completing at least 3 out of the 4 monitoring telemedicine visits	Baseline to week 24
Primary	Adherence to study drug	Adherence will be measured by pill count	Baseline to week 24
Primary	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	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
Secondary	Change in Asthma exacerbations rate	Change in (annualized) asthma exacerbations rate at week 24	Baseline to week 24
Secondary	Pre-bronchodilator lung function	Difference in volume of air exhaled in the first second during spirometry (FEV1) at week 24	Baseline to week 24
Secondary	Fractional exhaled nitric oxide (FeNO)	Difference in FeNO between baseline and week 24	Baseline to week 24
Secondary	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