Metformin Treatment for Children With Obesity-associated Asthma (MOACT)
30 de mayo de 2026 actualizado por: Prof Ibrahim Janahi
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:
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
182
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ibrahim Janahi, MD, FCCP, FRCPCH
- Número de teléfono: 00974 40032201
- Correo electrónico: ijanahi@sidra.org
Copia de seguridad de contactos de estudio
- Nombre: Ibrahim Janahi
Ubicaciones de estudio
-
-
Qa
-
Doha, Qa, Katar, 26999
- Sidra Medicine
-
Contacto:
- Ibrahim Janahi
-
Contacto:
- Ibrahim Janahi, MD, FCCP, FRCPCH
- Número de teléfono: 40037684
- Correo electrónico: IJanahi@sidra.org
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Metformin arm
Metformin tablets (Metformin XR, extended release 500 mg, oral tablet, active ingredient: metformin hydrochloride)
|
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. |
|
Comparador de placebos: Placebo arm
Placebo tablets of similar appearance, size, and color as that of metformin
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention
Periodo de tiempo: 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. |
26 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
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.
|
26 weeks
|
|
Assessing the impact of intervention treatment on corticosteroid use after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
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.
|
26 weeks
|
|
Assessing the impact of intervention treatment on forced expiratory volume in 1 second (FEV1) after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
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.
|
26 weeks
|
|
Assessing the impact of intervention treatment on forced vital capacity (FVC) after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
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.
|
26 weeks
|
|
Assessing the impact of intervention treatment on Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
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.
|
26 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessing the impact of intervention treatment on body mass index (BMI, kg/m²) measure after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
Change in body mass index (BMI) after 26 weeks of intervention, assessed as weight in kilograms divided by height in meters squared (kg/m²); lower BMI values or improvement toward age-appropriate BMI ranges indicate better weight management outcomes.
|
26 weeks
|
|
Assessing the impact of intervention treatment on peripheral blood eosinophil count after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
Peripheral blood eosinophil count after 26 weeks of intervention, assessed as the absolute eosinophil count in peripheral blood (cells/µL).
Lower eosinophil counts may indicate reduced type 2 inflammation and improved asthma control following the intervention.
|
26 weeks
|
|
Assessing the impact of intervention treatment on fasting plasma glucose after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
Fasting plasma glucose after 26 weeks of intervention, assessed by measuring fasting blood glucose concentration in plasma (mmol/L); lower values within the normal reference range indicate improved glycemic control and metabolic status.
|
26 weeks
|
|
Assessing the impact of intervention treatment on fasting insulin levels after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
Fasting insulin levels after 26 weeks of intervention, assessed by measuring fasting serum insulin concentration (pmol/L); lower fasting insulin levels within the normal reference range indicate improved insulin sensitivity and metabolic control.
|
26 weeks
|
|
Assessing the impact of intervention treatment on plasma cytokine levels after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
Changes in the levels of plasma cytokines including IL-22, IFN-γ, TNF-α, IL-2, IL-4, IL-5, IL-10, IL-13, IL-17A, IL-33, and leptin will be measured (pg/mL) after 26 weeks of intervention to evaluate the effect of the treatment on systemic inflammatory responses.
|
26 weeks
|
|
Assessing the impact of intervention treatment on plasma metabolomic and lipidomic profiles after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
Plasma metabolomic and lipidomic profiles will be measured as relative concentrations of metabolites and lipids (normalized intensity units) after 26 weeks of intervention to assess changes associated with the treatment.
|
26 weeks
|
|
Assessing the impact of intervention treatment on blood transcriptomic profile after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
Blood transcriptomic profile will be measured as normalized fold-change values in gene expression after 26 weeks of intervention to assess transcriptomic changes associated with the treatment.
|
26 weeks
|
|
Assessing the impact of intervention treatment on gut and salivary microbiome profile after 26 weeks of intervention
Periodo de tiempo: 26 weeks
|
Gut and salivary microbiome profiles will be measured as the relative abundance (%) and diversity indices of microbial taxa at the phylum, genus, and species levels after 26 weeks of intervention.
|
26 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ibrahim Janahi, MD, FCCP, FRCPCH, Chief Medical Officer
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de agosto de 2027
Finalización del estudio (Estimado)
1 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
12 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
30 de mayo de 2026
Publicado por primera vez (Actual)
3 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- SDR100071
- ARG01-0430-230037 (Otro número de subvención/financiamiento: Qatar Research Development and Innovation (QRDI))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .