Anti-Inflammatory Reliever South Africa

Recruiting Phase 3 Interventional Study
Asthma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,038 (estimated)
Sponsor
University of KwaZulu · Other
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About This Trial
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 enrol…
Trial Locations
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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 pati…
Contacts

Refiloe Masekela, PhD

800-555-5555

masekelar@ukzn.ac.za

CONTACT

Nompumelelo Ngobese

800-555-5555

nompumelelo.ngobese@ahri.org

CONTACT