Using metformin to improve asthma control in overweight and obese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, placebo-controlled pilot study investigating the effects of metformin on asthma control in overweight or obese adults who have poorly managed asthma despite using inhaled corticosteroids. Participants will be randomly assigned to receive either metformin or a placebo for six months, with regular telemedicine visits to monitor side effects and adherence. Asthma outcomes will be assessed at the start of the trial and again at three and six months to evaluate the feasibility of conducting a larger multi-center trial in the future.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Where it's running

• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Meredith C McCormack, M.D., M.H.S. — Johns Hopkins University
• Study coordinator: Rachelle Koehl, M.S.
• Email: rkoehl1@jhmi.edu
• Phone: 410-955-1530

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.