Obesity-associated AsthmaPhase 3MOACTNCT07622290
Metformin Treatment for Children With Obesity-associated Asthma
A Phase 3 study testing Metfomin in people with Obesity-associated Asthma, run by Prof Ibrahim Janahi at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Obesity-associated Asthma
- What is being tested?
- Metfomin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteQatar
- Study dates
- Jun 2026to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ibrahim Janahi contact
Qatar1 site
Sidra Medicine
Doha, Qa, 26999
Ibrahim Janahi, MD, FCCP, FRCPCH, 40037684, IJanahi@sidra.org
Ibrahim Janahi
About this study
Official title: The Role of Metformin in Asthma Control in Obese/Overweight Children, a Randomized Placebo Controlled Clinical Trial
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:
- 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.
Read the detailed description
The study is a randomized, double-blinded, placebo-controlled, parallel- group intervention trial aimed to recruit 182 overweight/obese children aged 10-17 years with mild, moderate, or severe persistent asthma from the outpatient Pediatric Pulmonology Department at Sidra Medicine, Qatar. Participants will be randomly assigned in a 1:1 ratio to receive either metformin or placebo for the intervention period of 26 weeks. The primary outcome is defined as an increase in the Asthma Control Test (ACT) score at the end of the treatment compared with baseline. Secondary outcomes include a decrease in annual rate of asthma exacerbations and corticosteroid use, as well as change in lung function, and pediatric asthma quality of life questionnaire (PAQLQ) score from baseline. Exploratory outcomes include changes in the body mass index, clinical parameters, plasma cytokine profile, plasma metabolomic and lipidomic profile, blood transcriptomic profile, and microbiome of gut and saliva after metformin/placebo intervention. Statistical analyses of all primary and secondary end points will be performed using intention-to-treat (ITT) principle and per protocol (PP) approaches.
- Conditions
- Obesity-associated Asthma
- Being tested
- Metfomin, Placebo
- Keywords
- obesity-associated asthma, pediatric asthma, metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetfominDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Metformin arm | Active comparator | Metformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride) Receives: Drug: Metfomin |
| Placebo arm | Placebo comparator | Placebo tablets of similar appearance, size, and color as that of metformin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (5)
Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention
Changes in the annualized asthma exacerbation rate during the intervention period, assessed by the total number of asthma exacerbations experienced per participant per year; lower exacerbation rates indicate better asthma control and improved clinical outcomes.
Measured: 26 weeks
Assessing the impact of intervention treatment on corticosteroid use after 26 weeks of intervention
Change in corticosteroid use during the intervention period, assessed by the frequency and/or dose of corticosteroid medication required by participants; reduced corticosteroid use indicates improved asthma control and better clinical outcomes.
Measured: 26 weeks
Assessing the impact of intervention treatment on forced expiratory volume in 1 second (FEV1) after 26 weeks of intervention
Forced expiratory volume in 1 second (FEV1) after 26 weeks of intervention, assessed as percent predicted FEV1 measured by spirometry; higher percent predicted FEV1 values indicate better pulmonary function and improved asthma control.
Measured: 26 weeks
Assessing the impact of intervention treatment on forced vital capacity (FVC) after 26 weeks of intervention
Forced vital capacity (FVC) after 26 weeks of intervention, assessed as percent predicted FVC measured by spirometry; higher percent predicted FVC values indicate better lung function and improved respiratory capacity.
Measured: 26 weeks
Assessing the impact of intervention treatment on Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores after 26 weeks of intervention
Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores after 26 weeks of intervention, assessed using the validated PAQLQ instrument; which measures both physical and emotional impact of asthma. The questionnaire has three domains including asthma symptoms (6 items), emotional function (4 items) and activity limitation (3 items), scale ranging from 1 to 7, where higher scores indicate better quality of life and improved symptom control.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity-associated AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Ibrahim Janahi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Ibrahim Janahi, Sidra Medicine
- Investigators
- Ibrahim Janahi, MD, FCCP, FRCPCH, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622290
- Sponsor's protocol ID
- SDR100071
- Other IDs
- ARG01-0430-230037
- Acronym
- MOACT
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Metformin in Asthma Control in Obese/Overweight Children, a Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07622290
- Acronym / sponsor ID
- MOACT / SDR100071
- Conditions
- Obesity-associated Asthma
- Keywords
- obesity-associated asthma, pediatric asthma, metformin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Prof Ibrahim JanahiUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
The study is a randomized, double-blinded, placebo-controlled, parallel- group intervention trial aimed to recruit 182 overweight/obese children aged 10-17 years with mild, moderate, or severe persistent asthma from the outpatient Pediatric Pulmonology Department at Sidra Medicine, Qatar. Participants will be randomly assigned in a 1:1 ratio to receive either metformin or placebo for the intervention period of 26 weeks. The primary outcome is defined as an increase in the Asthma Control Test (ACT) score at the end of the treatment compared with baseline. Secondary outcomes include a decrease in annual rate of asthma exacerbations and corticosteroid use, as well as change in lung function, and pediatric asthma quality of life questionnaire (PAQLQ) score from baseline. Exploratory outcomes include changes in the body mass index, clinical parameters, plasma cytokine profile, plasma metabolomic and lipidomic profile, blood transcriptomic profile, and microbiome of gut and saliva after metformin/placebo intervention. Statistical analyses of all primary and secondary end points will be performed using intention-to-treat (ITT) principle and per protocol (PP) approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin arm | Active comparator | Drug: MetfominMetformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride) |
| Placebo arm | Placebo comparator | Drug: PlaceboPlacebo tablets of similar appearance, size, and color as that of metformin |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetfominMetformin 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. | Drug | Metformin arm |
| PlaceboPlacebo 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. | Drug | Placebo arm |
Primary outcome
Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention
Time frame: 26 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.
5 secondary outcomes
Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention
Time frame: 26 weeks
Assessing the impact of intervention treatment on corticosteroid use after 26 weeks of intervention
Time frame: 26 weeks
Assessing the impact of intervention treatment on forced expiratory volume in 1 second (FEV1) after 26 weeks of intervention
Time frame: 26 weeks
Assessing the impact of intervention treatment on forced vital capacity (FVC) after 26 weeks of intervention
Time frame: 26 weeks
Assessing the impact of intervention treatment on Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores after 26 weeks of intervention
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ibrahim Janahi contact
Ibrahim Janahi, MD, FCCP, FRCPCH principal investigator
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metfomin in people with Obesity-associated Asthma, run by Prof Ibrahim Janahi at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Janahi, MD, FCCP, FRCPCH (00974 40032201, ijanahi@sidra.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.