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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: masekelar@ukzn.ac.za
• Phone: 800-555-5555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.