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New treatment option for Asthma
Official title Anti-Inflammatory Reliever South Africa
ClinicalTrials.gov ID: NCT06429475
What this study is testing
What is Budesonide/formoterol?
Budesonide/formoterol is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for asthma.
Also referred to as No other intervention names.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- 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...
- Ability to perform Peak Expiratory Flow rate and/or bronchodilator reversibility testing.
You likely can't join if
- 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.
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- Inability to present for follow-up or leaving the study area within 12 months of enrolment.
The study team makes the final eligibility decision.
Where it's taking place
- Mtubatuba, KwaZulu-Natal, South Africa
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mtubatuba, KwaZulu-Natal, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.