Metformin Treatment for Children With Obesity-associated Asthma

NCT07622290 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: SDR100071ARG01-0430-230037
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity-associated Asthma

Keywords

obesity-associated asthma; pediatric asthma; metformin

Outcome Measures

Primary Outcomes (1)

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

  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.

  26 weeks

Secondary Outcomes (5)

• Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention

  26 weeks

• Assessing the impact of intervention treatment on corticosteroid use after 26 weeks of intervention

  26 weeks

• Assessing the impact of intervention treatment on forced expiratory volume in 1 second (FEV1) after 26 weeks of intervention

  26 weeks

• Assessing the impact of intervention treatment on forced vital capacity (FVC) after 26 weeks of intervention

  26 weeks

• Assessing the impact of intervention treatment on Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores after 26 weeks of intervention

  26 weeks

Other Outcomes (8)

• Assessing the impact of intervention treatment on body mass index (BMI, kg/m²) measure after 26 weeks of intervention

  26 weeks

• Assessing the impact of intervention treatment on peripheral blood eosinophil count after 26 weeks of intervention

  26 weeks

• Assessing the impact of intervention treatment on fasting plasma glucose after 26 weeks of intervention

  26 weeks

Study Arms (2)

Metformin arm

ACTIVE COMPARATOR

Metformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride)

Drug: Metfomin

Placebo arm

PLACEBO COMPARATOR

Placebo tablets of similar appearance, size, and color as that of metformin

Drug: Placebo

Interventions

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.

Metformin arm

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.

Placebo arm

Eligibility Criteria

• Age: 10 Years - 17 Years
• Gender Eligibility Details: Male and Female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof Ibrahim Janahi: lead

Study Sites (1)

Sidra Medicine

Doha, Qa, 26999, Qatar

Location

Study Officials

• Ibrahim Janahi, MD, FCCP, FRCPCH

  Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrahim Janahi, MD, FCCP, FRCPCH

CONTACT

00974 40032201; ijanahi@sidra.org

Ibrahim Janahi

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Research co-ordinators, research nurses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)