Phase 3 Trial of BudesonideFormoterol Inhaler Versus Standard Asthma Care in South African Children and Adolescents Aged 6 to 18 Years

What this Trial Is About

This research aims to evaluate the effectiveness of budesonideformoterol inhalers compared to the standard asthma treatments in reducing asthma flare-ups over one year in children and adolescents aged 6 to 18 years with mild to moderate asthma. The study focuses on participants who have had at least one asthma exacerbation in the past year and is conducted as a Phase 3 randomized controlled trial at a single center. The trial addresses the high burden of asthma in South African children and adolescents and seeks to provide evidence for improved, affordable treatment approaches in low- and middle-income countries. Participants are randomly assigned to one of two groups one group receives budesonideformoterol inhalers at doses adjusted by age and symptom severity, used both for symptom relief and maintenance the other group continues with the standard care involving separate inhalers for relief and maintenance, prescribed by their doctors. The budesonideformoterol is delivered via inhalers with doses of 804.5 for children aged 6-11 and 1604.5 for those 12-18 years, taken as needed or twice daily depending on control. The study lasts 52 weeks, with visits at 13, 26, 39, and 52 weeks, including telephone follow-ups to monitor asthma attacks and medication changes. Throughout the study, participants undergo lung function tests, including peak flow measurements and bronchodilator reversibility testing, to confirm asthma diagnosis and monitor control. Researchers collect data on asthma exacerbations, hospital or clinic admissions, adverse events, and medication adjustments. Safety and trial conduct are overseen by independent expert committees. The main outcome is the number of asthma exacerbations over 52 weeks, with cost-effectiveness also evaluated. Participants and their families are supported and followed for the full year duration of the trial.

Anti-Inflammatory Reliever South Africa