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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin IN Asthma for Overweight and Obese Individuals (MINA)
- ClinicalTrials.gov ID
- NCT06273072
- Acronym / sponsor ID
- IRB00409080
- Conditions
- Asthma, Asthma Chronic, Overweight and Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Temple University
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin hydrochloride extended-release tablets | Active comparator | Drug: Metformin hydrochloride extended-release tabletsMetformin hydrochloride extended-release tablets 2000 mg once daily |
| Visually identical placebo tablets | Placebo comparator | Drug: Visually identical placebo Metformin hydrochloride extended-release tabletsPlacebo tablet once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin hydrochloride extended-release tabletstitrated to 2000 mg once daily | Drug | Metformin hydrochloride extended-release tablets |
| Visually identical placebo Metformin hydrochloride extended-release tabletsplacebo | Drug | Visually identical placebo tablets |
Primary outcome
Number of completed telemedicine visits
Time frame: Baseline to week 24
Number of participants completing at least 3 out of the 4 monitoring telemedicine visits
Adherence to study drug
Time frame: Baseline to week 24
Adherence will be measured by pill count
Retention rate
Time frame: Baseline to week 24
Investigators will collect data on the number of subjects screened, randomized, and complete the final in-person visit
5 secondary outcomes
Asthma control as assessed by the Asthma Control Test (ACT) score
Time frame: Baseline to week 24
Change in Asthma exacerbations rate
Time frame: Baseline to week 24
Pre-bronchodilator lung function
Time frame: Baseline to week 24
Fractional exhaled nitric oxide (FeNO)
Time frame: Baseline to week 24
Airways hyperresponsiveness
Time frame: Baseline to week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meredith C McCormack, M.D., M.H.S. principal investigator
Johns Hopkins University
Tianshi D Wu, M.D., M.H.S. principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachelle Koehl, M.S. (410-955-1530, rkoehl1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of completed telemedicine visits (time frame: Baseline to week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.