Actively Recruiting
Anti-Inflammatory Reliever South Africa
Led by University of KwaZulu · Updated on 2026-01-15
1038
Participants Needed
2
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 3 single-centre open label randomised controlled trial with two equal sized groups to assess the efficacy of budesonide/formoterol 80/4.5 (6-11 years) and 160/4.5 (12-18 years) compared to the standard of care in reducing asthma exacerbations over 52 weeks. Children and adolescents with a diagnosis of asthma or newly diagnosed with asthma will be screened for eligibility for enrolment. Those who had an asthma exacerbation in the previous year will be randomised 1:1, to either receive budesonide/formoterol inhaler for both symptom relief and for chronic anti- inflammatory maintenance therapy or the standard of care which is separate inhalers for symptom relief (short acting bronchodilator salbutamol) and chronic maintenance therapy with inhaled corticosteroids (beclomethasone or budesonide) and/or long-acting beta agonists or montelukast as determined by treating physicians. All asthma exacerbations and clinic/hospital admissions will be recorded for the duration of the 52-week follow-up. Participants will be followed up at 13, 26, 39 and 52 weeks. The 13- and 39-week visit will be telephonic visits to capture the primary end-point i.e. asthma exacerbations. Adverse events and medication changes data will also be collected. An independent Data and Safety Monitoring Board (DSMB) will be convened for this study with expertise in asthma and asthma clinical trials. The purpose of the DSMB will be to monitor the study for safety and operational futility with pre-defined stopping criteria. In addition, a Trial Steering Committee (TSC) will also provide overall supervision of the trial and ensure the trial is delivered in accordance with ICH-GCP. The TSC has been established with an independent Chair and include additional independent members including an observer early career researcher. Representatives of the Trial Funder (NIHR) and Sponsor (AHRI) will be invited to all TSC meetings.
CONDITIONS
Official Title
Anti-Inflammatory Reliever South Africa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 6 to 18 years at the time of consent
- Known asthma diagnosis on treatment or newly diagnosed asthma confirmed by investigator
- Asthma diagnosis confirmed by spirometry with reversibility or peak expiratory flow rate variability over 2 weeks
- Ability to perform peak expiratory flow rate and/or bronchodilator reversibility testing
- Mild or moderate asthma based on medical history
- At least one asthma exacerbation in the past year requiring systemic corticosteroids for 3 or more days and/or hospitalization or emergency visit
- Written consent from participant or parent/guardian and assent from participants when applicable
- Agreement to comply with study procedures and be available for scheduled visits and telephonic follow-ups
You will not qualify if you...
- Active tuberculosis disease or contact with people with active tuberculosis in the last 6 months
- Chronic sputum production, chest pain, shortness of breath, dizziness, or light-headedness in the last 2 months
- Cardiac arrhythmia
- Chronic conditions including thyrotoxicosis, pheochromocytoma, cardiovascular disease, or severe hypertension
- Uncontrolled diabetes mellitus
- Peak expiratory flow rate less than 50% of predicted (severe asthma)
- History of life-threatening asthma episodes requiring intubation or associated with severe complications
- Use of biological or immunomodulatory therapies or regular oral prednisolone for asthma management
- Any medical or surgical condition affecting drug metabolism that may affect safety
- Any physical, mental, social condition or lab abnormality that may interfere with safety or study adherence
- Inability to attend follow-up visits or leaving the study area within 12 months of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Africa Research Health Institute Clinical Trial Unit
Mtubatuba, KwaZulu-Natal, South Africa, 3935
Actively Recruiting
2
Africa Research Health Institute Clinical Trial Unit
Mtubatuba, KwaZulu-Natal, South Africa, 3965
Actively Recruiting
Research Team
R
Refiloe Masekela, PhD
CONTACT
N
Nompumelelo Ngobese
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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