Anti-inflammatory reliever therapy for children and teens with asthma in South Africa

Anti-Inflammatory Reliever Therapy for Asthma Using Inhaled Budesonide/Formoterol As-needed With or Without Maintenance in South African Children: A Pragmatic Open Label Phase 3 Randomised Controlled Trial

This test will see if a single budesonide/formoterol inhaler used for both symptom relief and daily control reduces asthma attacks over one year in children and teens aged 6–18 compared with standard separate inhalers.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1038 (estimated)
• Ages: 6 Years to 18 Years
• Sex: All
• Sponsor: University of KwaZulu (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 2 sites (Mtubatuba, KwaZulu-Natal and 1 other locations)
• Trial ID: NCT06429475 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, single-center, open-label randomized trial that will assign children and adolescents 1:1 to either budesonide/formoterol as a single inhaler for both reliever and maintenance use or to standard care with separate reliever and maintenance inhalers. Eligible participants are aged 6–18 with mild or moderate asthma and at least one exacerbation in the prior year, with diagnosis confirmed by spirometry or peak flow variability. The primary outcome is the rate of asthma exacerbations and related clinic/hospital admissions recorded over 52 weeks. Treatment choices in the standard-care arm (inhaled corticosteroid ± long-acting bronchodilator or montelukast) are determined by the treating physician.

Who should consider this trial

Good fit: Children and adolescents aged 6–18 with confirmed mild or moderate asthma who have had at least one exacerbation in the past year and can perform spirometry or peak flow testing are ideal candidates.

Not a fit: Patients with severe asthma, without a recent exacerbation, under age 6 or unable to perform required lung function testing, or with contraindications to the study drugs are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could reduce exacerbations and hospital visits while simplifying treatment to a single inhaler for children and adolescents.

How similar studies have performed: Previous trials of single-inhaler budesonide/formoterol as both reliever and maintenance have reduced exacerbations in older children and adults, though pediatric and low-resource setting data remain more limited.

Eligibility criteria

Inclusion Criteria:

* Age for inclusion children and adolescents 6-18 years at the time of consent
* Known asthmatic on treatment.
* Newly diagnosed asthma based on investigator review and/or medical report.
* All patients will have their asthma diagnosis confirmed (both new or known asthmatic patients) by either spirometry with reversibility or excessive diurnal variability by PEFR twice daily over 2 weeks.
* Ability to perform Peak Expiratory Flow rate and/or bronchodilator reversibility testing.
* Only participants with mild, or moderate asthma , based on medical history
* At least one exacerbation of asthma in the past year as defined by an event requiring treatment with systemic corticosteroids for ≥3 days and/or a hospitalisation/emergency room visit for asthma requiring treatment with systemic corticosteroids.
* Written consent from the participant or parent/guardian and assent from study participants where applicable.
* Participant and/or parent/guardian agrees to comply with the study procedures, including the completion of the visits and be available for contact for telephonically for the non-contact visits

Exclusion Criteria:

* Tuberculosis (TB): active TB disease and contact with people with active TB disease in the last 6 months.
* Chronic sputum expectoration, chest pain, shortness of breath, dizziness, or light-headedness in the last 2 months.
* Cardiac arrythmia.
* Chronic conditions: thyrotoxicosis, phaeochromocytoma, cardiovascular disease, severe hypertension.
* Uncontrolled diabetes mellitus
* Patients with Peak Expiratory Flow Rate \< 50% of predicted , as these would be classified as severe asthmatics.
* Patients with any history of life-threatening asthma, defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).
* Any use of biological therapy or immunomodulatory therapy such as methotrexate or regular oral prednisolone for the asthma management (STEP 5 GINA therapy).
* Any surgical or medical condition that would significantly alter the absorption, distribution, metabolism or excretion of the IMP which may jeopardise the safety of the participants. The investigator should make this determination in consideration of the volunteer's medical history.
* Any physical, mental or social condition, laboratory abnormality of history of illness that in the investigator's judgement might jeopardise the safety of the participant in the context of the study or might interfere with study procedures or the ability of the participant to adhere to and complete the study. The investigator should make this determination consideration of the volunteer's medical history.
* Inability to present for follow-up or leaving the study area within 12 months of enrolment.

Where this trial is running

Mtubatuba, KwaZulu-Natal and 1 other locations

• Africa Research Health Institute Clinical Trial Unit — Mtubatuba, KwaZulu-Natal, South Africa (Recruiting)
• Africa Research Health Institute Clinical Trial Unit — Mtubatuba, KwaZulu-Natal, South Africa (Recruiting)

Study contacts

• Study coordinator: Refiloe Masekela, PhD

Conditions Asthma; asthma; budesonide/formoterol; beclomethasone; budesonide; children; adolescents