AsthmaPhase 2NCT06273072
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
A Phase 2 study testing Metformin hydrochloride extended-release tablets in people with Asthma and Asthma Chronic, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Asthma Chronic, Overweight and Obesity
- What is being tested?
- Metformin hydrochloride extended-release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Dec 2024to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21224
Rachelle Koehl, 410-955-1530, rkoehl1@jhmi.edu
Meredith C McCormack, M.D., M.H.S.
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Tianshi D Wu, M.D., M.H.S.
About this study
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
Read the 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.
- Conditions
- Asthma, Asthma Chronic, Overweight and Obesity
- Being tested
- Metformin hydrochloride extended-release tablets, Visually identical placebo Metformin hydrochloride extended-release tablets
- Medical subject headings
- Asthma, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin hydrochloride extended-release tabletsDrug
titrated to 2000 mg once daily
Visually identical placebo Metformin hydrochloride extended-release tabletsDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Metformin hydrochloride extended-release tablets | Active comparator | Metformin hydrochloride extended-release tablets 2000 mg once daily Receives: Drug: Metformin hydrochloride extended-release tablets |
| Visually identical placebo tablets | Placebo comparator | Placebo tablet once daily Receives: Drug: Visually identical placebo Metformin hydrochloride extended-release tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed telemedicine visits
Number of participants completing at least 3 out of the 4 monitoring telemedicine visits
Measured: Baseline to week 24
Adherence to study drug
Adherence will be measured by pill count
Measured: Baseline to week 24
Retention rate
Investigators will collect data on the number of subjects screened, randomized, and complete the final in-person visit
Measured: Baseline to week 24
Secondary outcomes (5)
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
Measured: Baseline to week 24
Change in Asthma exacerbations rate
Change in (annualized) asthma exacerbations rate at week 24
Measured: Baseline to week 24
Pre-bronchodilator lung function
Difference in volume of air exhaled in the first second during spirometry (FEV1) at week 24
Measured: Baseline to week 24
Fractional exhaled nitric oxide (FeNO)
Difference in FeNO between baseline and week 24
Measured: 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
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start9 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Temple University
- Responsible party
- Sponsor
- Investigators
- Meredith C McCormack, M.D., M.H.S., Principal investigator, Johns Hopkins UniversityTianshi D Wu, M.D., M.H.S., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273072
- Sponsor's protocol ID
- IRB00409080
- Other IDs
- R34HL166438-01A1
- Status last verified
- Oct 2026
- First submitted
- 15 Feb 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No