NCT06429475 Anti-Inflammatory Reliever South Africa
| NCT ID | NCT06429475 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of KwaZulu |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,038 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,038 participants in total. It began in 2024-06-06 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Limakatso Lebina, PhD
STUDY DIRECTOR
Africa Health Research Institute
Frequently Asked Questions
Who can join the NCT06429475 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06429475 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,038 participants.
Is NCT06429475 currently recruiting?
Yes, NCT06429475 is actively recruiting participants. Contact the research team at masekelar@ukzn.ac.za for enrollment information.
Where is the NCT06429475 trial being conducted?
This trial is being conducted at Mtubatuba, South Africa, Mtubatuba, South Africa.
Who is sponsoring the NCT06429475 clinical trial?
NCT06429475 is sponsored by University of KwaZulu. The principal investigator is Limakatso Lebina, PhD at Africa Health Research Institute. The trial plans to enroll 1,038 participants.
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