Clinical trial

Metformin Treatment for Children With Obesity-associated Asthma

Opening soon · Phase 3 · 1 countries · Registry ID NCT07622290

Opening soonPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity-associated Asthma

Full registry criteria

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

Treatments and study arms

Metfomin

Drug

Metformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride). The prolonged release metformin tablets 500 mg (Brand Name: GLUCOLIFE XR ® 500) will be provided by QLife Pharma manufacturer, Doha, Qatar. Metformin tablet description: White to off white, capsule shaped, biconvex, beveled edge tablet, with occasionally mottled appearance, debossed with "TL 001" on one side and plain on other side.

Placebo

Drug

Placebo description: 500 mg, white to off white capsule shaped biconvex, beveled edge tablet, with occasionally mottled appearance, debossed with "TL 001" on one side and plain on other side. Placebo will be provided by QLife Pharma manufacturer, Doha, Qatar.

Primary outcomes

Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention26 weeks

The primary outcome measure is the change in the Asthma Control Test (ACT) score after 26 weeks of intervention. The ACT is a validated questionnaire used to assess asthma control, including symptoms such as cough, wheezing, use of bronchodilators, nocturnal symptoms, shortness of breath, and limitations in daily activities. For participants aged 12-17 years, the ACT score ranges from 0 to 25, where higher scores indicate better asthma control. Scores of 21-25 represent well-controlled asthma, 16-20 indicate poorly controlled asthma, and 0-15 indicate very poorly controlled asthma. For participants aged 4-11 years, the Childhood Asthma Control Test (C-ACT) score ranges from 0 to 27, where higher scores also indicate better asthma control. Scores of 21-27 represent well-controlled asthma, 13-20 indicate poorly controlled asthma, and 0-12 indicate very poorly controlled asthma.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Sidra Medicine🌐 Doha, Qa, Qatar

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Ibrahim Janahi, MD, FCCP, FRCPCHContact

Email · Call 40037684

Ibrahim JanahiContact