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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
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2028

Study information

Verified date May 2024
Source Johns Hopkins University
Contact Rachelle Koehl, M.S.
Phone 410-955-1530
Email rkoehl1@jhmi.edu
Is FDA regulated No
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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