Metformin for Asthma

Recruiting at 1 trial location

Overseen By Meredith C McCormack, M.D., M.H.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: GLP-1, Metformin

Disqualifiers: Pregnancy, Cardiovascular disease, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether metformin, a common diabetes medication, can improve asthma control in overweight or obese individuals. Participants will receive either metformin or a placebo (a sugar pill with no active ingredients) to determine if metformin affects asthma symptom management. The trial seeks adults with poorly controlled asthma despite using inhalers. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain diabetes medications or GLP-1 medications for weight loss.

Is there any evidence suggesting that metformin is likely to be safe for humans?

Research has shown that metformin is usually safe for use. Studies have found that metformin may reduce asthma attacks in individuals with both asthma and diabetes. Some research also suggests that metformin can help those with asthma and metabolic syndrome (a group of conditions like high blood pressure and high blood sugar) breathe better and improve their quality of life.

While these findings are encouraging, it is important to note that the FDA has already approved metformin for treating diabetes, indicating its safety is well understood. However, its use specifically for asthma remains under investigation. Researchers are still studying any possible side effects or risks associated with asthma treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Metformin is unique for asthma treatment because, unlike traditional options like inhaled corticosteroids and bronchodilators that primarily target airway inflammation and muscle relaxation, metformin is an oral medication that may reduce inflammation at a systemic level. Researchers are excited about its potential to modify the underlying metabolic processes that contribute to asthma symptoms. By leveraging metformin's mechanism of improving insulin sensitivity and reducing inflammation, this treatment could offer a novel approach to managing asthma, particularly for patients with concurrent metabolic conditions.

What evidence suggests that metformin might be an effective treatment for asthma?

Research has shown that metformin, a drug often used for diabetes, might help people with asthma. Some studies suggest it can reduce airway swelling and ease breathing. Evidence also indicates that metformin could lower the number of severe asthma attacks and emergency room visits, although results remain inconclusive. Metformin may help by reducing airway sensitivity to allergens or irritants. Overall, early findings are promising, but more research is needed to confirm its effectiveness for asthma. Participants in this trial will receive either metformin hydrochloride extended-release tablets or visually identical placebo tablets to further investigate its potential benefits for asthma. ^{2 3 6 7 8}

Who Is on the Research Team?

Tianshi D Wu, M.D., M.H.S.

Principal Investigator

Baylor College of Medicine

Meredith C McCormack, M.D., M.H.S.

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

The MINA trial is for adults over 18 who are overweight or obese (BMI ≥25kg/m2) with asthma that isn't well-controlled despite using maintenance inhalers. Participants must have had either an ACT score below 20 or an asthma exacerbation requiring steroids in the past year.

Inclusion Criteria

I have asthma and am on regular treatment for it.

My BMI is 25 or higher, indicating I am overweight or obese.

My asthma is not well-controlled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either metformin or placebo daily for six months

24 weeks

4 telemedicine visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Metformin

Trial Overview This study tests if metformin, a medication commonly used for diabetes, can help control asthma symptoms in overweight and obese individuals. It's a randomized trial where participants will receive either metformin or a placebo without knowing which one they're taking.

How Is the Trial Designed?

Group I: Metformin hydrochloride extended-release tablets Active Control 1 Intervention

Metformin hydrochloride extended-release tablets 2000 mg once daily

Group II: Visually identical placebo tablets Placebo Group 1 Intervention

Placebo tablet once daily

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Temple University

Collaborator

Trials

321

Recruited

89,100+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

New leukotriene modulators, such as montelukast, zafirlukast, and zileuton, have been developed to improve asthma control by reducing symptoms and the need for rescue medications.

These medications are effective for patients with mild intermittent to moderate persistent asthma, as they help improve pulmonary function and overall management of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive asthma management: guidelines for clinicians. Kemp, JP.[2019]

Methotrexate has been evaluated in 13 studies for treating difficult-to-treat asthma, showing a mean reduction of 35% in the corticosteroid dose needed for symptom control.

While there are potential adverse effects, methotrexate may be a beneficial treatment option for certain patients with severe asthma when monitored closely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Methotrexate may be a useful corticosteroid reducing treatment of severe asthma]. Knarborg, M., Hilberg, O., Dahl, R.[2017]

The review discusses the efficacy and safety of FDA-approved biological agents for treating severe persistent asthma in patients who do not respond well to standard management strategies.

It also highlights upcoming biological agents that are expected to receive FDA approval, indicating ongoing advancements in asthma treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunomodulators and Biologics: Beyond Stepped-Care Therapy. Desai, M., Oppenheimer, J., Lang, DM.[2020]

In a study analyzing prescribing patterns from the National Health Insurance Research Database, oral beta-2 agonists were the most commonly prescribed medication for both pediatric patients with asthma (52.6-77.6%) and those without asthma (62.8-84.8%).

Combination therapies, such as oral beta-2 agonists with xanthines or corticosteroids, were frequently used in both groups, indicating that treatment approaches for respiratory issues may not significantly differ between asthmatic and non-asthmatic children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribing patterns of anti-asthma drugs in pediatric patients. Sun, HL., Lue, KH., Kao, YH.[2008]

In a review of 66 trials with 20,966 participants, combining salmeterol with inhaled corticosteroids significantly reduced the risk of severe asthma-related exacerbations compared to inhaled corticosteroids alone.

The combination treatment did not show a significant difference in the rates of asthma-related hospitalizations, intubations, or deaths, suggesting it is safe in terms of these serious outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis: effects of adding salmeterol to inhaled corticosteroids on serious asthma-related events. Bateman, E., Nelson, H., Bousquet, J., et al.[2022]

A comprehensive analysis of 372,345 spontaneous reports from 2011 to 2017 identified 385 different safety signals related to asthma medications in children, with a notable focus on psychiatric events, highlighting the importance of monitoring these drugs in the pediatric population.

The study uncovered new safety signals, such as herpes viral infections linked to omalizumab and hypertrichosis associated with budesonide, emphasizing that age stratification is crucial for detecting unique risks in children that may not be evident in the broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. Baan, EJ., de Smet, VA., Hoeve, CE., et al.[2021]

In a study of six steroid-dependent asthmatic children aged 7 to 13, methotrexate therapy improved clinical symptoms and allowed for a reduction in prednisone dosage, with three patients completely stopping prednisone.

However, while methotrexate showed potential as an alternative treatment, adverse effects like leukopenia and herpes zoster were observed, and symptoms worsened upon stopping methotrexate, indicating the need for careful monitoring and further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Methotrexate for steroid-dependent asthmatic children and adolescents]. Zella, MJ., Pastorino, AC., Jacob, CM., et al.[2020]

In a survey of 1,351 asthma patients aged 18-50, nearly 59% reported adverse events (AEs) related to their asthma therapy, with tiredness and palpitations being the most common symptoms.

Patients with poor asthma control and those who perceive their asthma as a handicap were significantly more likely to report multiple AEs, suggesting that better education and management of asthma could improve treatment acceptability and reduce reported side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported adverse events under asthma therapy: a community pharmacy-based survey. Laforest, L., Van Ganse, E., Devouassoux, G., et al.[2015]

Asthma prevalence in children has dramatically increased by 160% since 1980, affecting nearly 5 million children in the U.S., highlighting the urgent need for effective management strategies.

The National Asthma Education and Prevention Program recommends a comprehensive, stepwise approach to asthma management, emphasizing regular monitoring, control of triggers, and the use of inhaled corticosteroids as the most effective long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of asthma in children. Kemp, JP., Kemp, JA.[2007]

The 2007 NAEPP guidelines emphasize a stepwise approach to asthma management, focusing on achieving current control to reduce future risks, which represents a significant shift in asthma treatment strategy.

Despite the FDA's concerns about the safety of asthma medications and the recommendation to step down therapy after achieving control, there is a lack of randomized controlled trials to support this practice, leaving current guidelines with limited evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on asthma step-therapy. Dinakar, C.[2016]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40787554/

a double-blind, randomized, placebo-controlled clinical trial Although the metformin group demonstrated a trend toward a reduction in severe asthma attacks, ED visits, or hospitalization rates, the effects ...

2. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/08000/metformin_effects_on_respiratory_and_metabolic.29.aspx

Metformin effects on respiratory and metabolic outcomes in... Metformin has been suggested as a potential treatment for MetS, which could decrease airway reactivity and lead to improved asthma control and reduced emergency ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11460891/

Association of metformin use with asthma development and ... Research has suggested that metformin, a commonly used medication for diabetes management, may also have beneficial effects in enhancing asthma outcomes.

4. researchgate.net researchgate.net/publication/394376876_Metformin_effects_on_respiratory_and_metabolic_outcomes_in_asthma_and_metabolic_syndrome_a_double-blind_randomized_placebo-controlled_clinical_trial

Metformin effects on respiratory and metabolic outcomes in ... Metformin has been suggested as a potential treatment for MetS, which could decrease airway reactivity and lead to improved asthma control and ...

5. pharmacist.com pharmacist.com/Blogs/CEO-Blog/recent-study-links-diabetes-medication-to-reduced-asthma-attacks

Recent study links diabetes medication to reduced asthma ... Previous findings suggest metformin may reduce airway inflammation and hyperresponsiveness, potentially influencing asthma outcomes. However, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12333733/

Metformin effects on respiratory and metabolic outcomes in ... Our findings demonstrate that metformin administration in patients with concurrent asthma and MetS could lead to substantial enhancements in ACT score, FEV1, ...

7. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-021-01658-3

Metformin use and respiratory outcomes in asthma-COPD ... Metformin use was associated with fewer respiratory exacerbations and improved quality of life among individuals with ACO but not COPD alone.

8. thecardiologyadvisor.com thecardiologyadvisor.com/news/metformin-use-tied-to-lower-rate-of-asthma-attacks/

Metformin Use Tied to Lower Rate of Asthma Attacks Metformin is associated with a lower rate of asthma attacks among people with diabetes, according to a study published online Nov. 18 in JAMA Internal Medicine.