Metformin IN Asthma for Overweight and Obese Individuals (MINA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin hydrochloride extended-release tablets
Drugtitrated to 2000 mg once daily
Visually identical placebo Metformin hydrochloride extended-release tablets
Drugplacebo
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Metformin hydrochloride extended-release tabletsActive comparator 1 intervention
Group B: Visually identical placebo tabletsPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of completed telemedicine visits
Number of participants completing at least 3 out of the 4 monitoring telemedicine visits
Time frame
Baseline to week 242
Adherence to study drug
Adherence will be measured by pill count
Time frame
Baseline to week 243
Retention rate
Investigators will collect data on the number of subjects screened, randomized, and complete the final in-person visit
Time frame
Baseline to week 24Secondary outcomes
1
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
Time frame
Baseline to week 242
Change in Asthma exacerbations rate
Change in (annualized) asthma exacerbations rate at week 24
Time frame
Baseline to week 243
Pre-bronchodilator lung function
Difference in volume of air exhaled in the first second during spirometry (FEV1) at week 24
Time frame
Baseline to week 244
Fractional exhaled nitric oxide (FeNO)
Difference in FeNO between baseline and week 24
Time frame
Baseline to week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Baylor College of Medicine
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Temple University
Collaborator
Source ClinicalTrials.gov