Metformin for Asthma

Recruiting in Palo Alto (17 mi)

+1 other location

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

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: GLP-1, Metformin

Disqualifiers: Pregnancy, Cardiovascular disease, Diabetes, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.

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 Metformin generally safe for humans?

Metformin is a medication commonly used to treat type 2 diabetes and has been widely studied for its safety in humans. It is generally considered safe, with common side effects including stomach upset and diarrhea, but it is important to discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

How does the drug Metformin differ from other asthma treatments?

Metformin is unique for asthma treatment because it is traditionally used to manage diabetes by improving insulin sensitivity, whereas most asthma treatments focus on reducing inflammation or relaxing airway muscles. This novel approach could offer a different mechanism of action compared to standard asthma medications like inhaled corticosteroids or beta-2 agonists. ^{6 7 8 9 10}

Research Team

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

Eligibility Criteria

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.

I am 18 years old or older.

Trial Timeline

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

Treatment Details

Interventions

• Metformin (Anti-diabetic agent)

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.

Participant Groups

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+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Paul Klotman

Baylor College of Medicine

Chief Executive Officer since 2010

MD, PhD

James Versalovic

Baylor College of Medicine

Chief Medical Officer since 2020

MD from Baylor College of Medicine

Temple University

Collaborator

Trials

321

Recruited

89,100+

Dr. Kumar Budur

Temple University

Chief Medical Officer

MD, MS

Dr. Jeffrey M. Dayno

Temple University

Chief Executive Officer

MD from Temple University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient-reported adverse events under asthma therapy: a community pharmacy-based survey. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis: effects of adding salmeterol to inhaled corticosteroids on serious asthma-related events. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Immunomodulators and Biologics: Beyond Stepped-Care Therapy. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Update on asthma step-therapy. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Management of asthma in children. [2007]

7. England pubmed.ncbi.nlm.nih.gov

Comprehensive asthma management: guidelines for clinicians. [2019]

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Prescribing patterns of anti-asthma drugs in pediatric patients. [2008]

9. Brazil pubmed.ncbi.nlm.nih.gov

[Methotrexate for steroid-dependent asthmatic children and adolescents]. [2020]

10. Denmark pubmed.ncbi.nlm.nih.gov

[Methotrexate may be a useful corticosteroid reducing treatment of severe asthma]. [2017]