Metformin Treatment for Children With Obesity-associated Asthma (NCT07622290) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Metformin Treatment for Children With Obesity-associated Asthma
Qatar182 participantsStarted 2026-06
Plain-language summary
The goal of this clinical trial is to learn if metformin can improve asthma control in overweight and obese children with mild, moderate, or severe asthma. It will also evaluate the safety and metabolic effects of metformin in this population. The main questions the study aims to answer are:
1\) Does metformin improve asthma control, as measured by the Asthma Control Test (ACT) score? 2) Does metformin improve lung function, reduce asthma exacerbations, and improve metabolic and inflammatory markers in overweight/obese children with asthma? Researchers will compare metformin with a placebo (a look-alike substance that contains no active drug) to see if metformin improves asthma outcomes in overweight/obese children with asthma. Participants will take either metformin or a placebo in addition to their standard asthma treatment during the study period. They will attend scheduled clinic visits for asthma assessments, lung function testing, and safety monitoring. Blood, stool, and saliva samples, along with clinical information, will be collected from participants to assess asthma control, and markers related to metabolism and inflammation. Participants will also complete asthma control questionnaires and report medication use and asthma symptoms throughout the study period.
Who can participate
Age range
10 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant who are capable of giving assent and parentral consent
* Male/Female participant aged between10-17 years old,
* overweight/obese children (Overweight and obesity are defined as BMI equal and above the 85th percentile, and BMI above the 95th percentile for age and sex, respectively).
* Diagnosed with mild persistent, moderate persistent /severe asthma based on GINA guidelines within the 6 months prior to the recruitment date and having ACT score \< 20, residing in Qatar
* Partcipants on standard asthma therapy for at least the last 6 months prior to the recruitment
* Participant who are currently not taking part in any other interventional study
Exclusion Criteria:
* Non-asthma chronic lung disease
* Broncho-pulmonary dysplasia
* Inflammatory bowel disease
* Syndromic disorders (e.g. Down's syndrome, Turner's syndrome)
* Inborn errors of metabolism
* Symptomatic or previously symptomatic congenital heart disease
* Craniofacial abnormalities
* Primary thoracic cage abnormalities
* Neuromuscular disorders
* Swallowing disorders
* Secondary endocrinopathies causing obesity
* Renal complications
* Ongoing treatment for cancer
* Taking metformin or GLP1 medication less than 3 months of the recruitment date
* Children diagnosed with type-1 diabetes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing metformin — a diabetes medication — in children with obesity-related asthma, so could you explain why metformin might help with asthma control specifically, and whether there's enough early-phase evidence to feel confident about trying it in my child?
2The trial hasn't started recruiting yet, so realistically how long might it be before my child could actually enroll, and should we be pursuing other treatment options in the meantime rather than waiting?
3The main thing this study is measuring is the Asthma Control Test score after 26 weeks — can you help me understand what a meaningful improvement in that score would actually look like for my child's day-to-day life, like fewer flare-ups or less need for rescue inhalers?
4Since this is a Phase 3 trial, what do we already know about metformin's safety in children, and are there side effects specific to kids with asthma or obesity that I should be aware of before considering this?
5Are there standard asthma treatments or weight management programs already available that might improve my child's asthma control without joining a trial, and how would you compare those options to what this study is offering?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention