Набор скоро начнётся NCT07622290

Metformin Treatment for Children With Obesity-associated Asthma

Фаза III С лечением Obesity-associated Asthma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Metfomin, Placebo.
Кому может быть актуально: Состояния в реестре: Obesity-associated Asthma. Базовые параметры: 10 лет — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Катар
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Role of Metformin in Asthma Control in Obese/Overweight Children, a Randomized Placebo Controlled Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

Препарат Metfomin
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.
Препарат Placebo
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.

Первичные конечные точки

Assessing the impact of intervention treatment on change in asthma control test questionnaire (ACT) score after 26 weeks of intervention [Срок оценки: 26 weeks]

Вторичные конечные точки (5)

Assessing the impact of intervention treatment on the annualized asthma exacerbation rate after 26 weeks of intervention [Срок оценки: 26 weeks]
Assessing the impact of intervention treatment on corticosteroid use after 26 weeks of intervention [Срок оценки: 26 weeks]
Assessing the impact of intervention treatment on forced expiratory volume in 1 second (FEV1) after 26 weeks of intervention [Срок оценки: 26 weeks]
Assessing the impact of intervention treatment on forced vital capacity (FVC) after 26 weeks of intervention [Срок оценки: 26 weeks]
Assessing the impact of intervention treatment on Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores after 26 weeks of intervention [Срок оценки: 26 weeks]

Критерии участия

Критерии включения

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