One inhaler to rule them all? new asthma study for kids
NCT ID NCT06429475
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using one inhaler (budesonide/formoterol) for both quick relief and daily control can reduce asthma attacks in children ages 6-18 in South Africa. About 1,038 kids with asthma will be split into two groups: one gets the single inhaler, the other gets separate inhalers for relief and control. The study lasts 52 weeks and tracks how many asthma attacks each group has.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,038 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Africa Research Health Institute Clinical Trial Unit
RECRUITINGMtubatuba, KwaZulu-Natal, 3935, South Africa
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Africa Research Health Institute Clinical Trial Unit
RECRUITINGMtubatuba, KwaZulu-Natal, 3965, South Africa
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