Anti-inflammatory reliever therapy for asthma using inhaled budesonide/formoterol as-needed with or without maintenance in South African children (AIR-SA 001): a description of a randomised clinical trial protocol
This study has been registered and approved by the South African Health Regulatory Authority 20231016, on 14 December 2023, KwaZulu Natal Health Research Committee KZ_202304_008 on 11 January 2024, University of KwaZulu Natal Biomedical Research Ethics Committee BREC/0000/5663/2023 on 6 February 2024, South African Clinical Trials Register DOH-27-032024-4778 on 14 March 2024, ClinicalTrial.gov NCT06429475 on 20 May 2024 and Pan African Clinical Trial Registry on 27 February 2025; the unique identification number for the registry is PACTR202502547023775.
Authors
- Josue Mbonigaba (ORCID: https://orcid.org/0000-0002-6014-233X)
- Edwin Mkwanazi (ORCID: https://orcid.org/0000-0002-7260-5629)
- Limakatso Lebina (ORCID: https://orcid.org/0000-0001-6825-0573)
- Kelli Bird (ORCID: https://orcid.org/0000-0002-3349-5770)
- Kennedy Otwombe (ORCID: https://orcid.org/0000-0002-7433-4383)
- Refiloe Masekela (ORCID: https://orcid.org/0000-0001-9665-2035)
- Kevin Mortimer
- Sbekezelo Hlophe (ORCID: https://orcid.org/0000-0001-8183-7977)
- N Ngobese
- NN Ndimande
Institutions
- University of Liverpool (GB)
- University of the Witwatersrand (ZA)
- Aintree University Hospitals NHS Foundation Trust (GB)
- Africa Health Research Institute (ZA)
- University of KwaZulu-Natal (ZA)
Publication Details
- Journal
- BMJ Open Respiratory Research
- Published
- 2025-11-01
- DOI
- https://doi.org/10.1136/bmjresp-2025-003378
- Primary Topic
- Asthma and respiratory diseases
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Government of the United Kingdom
- National Institute for Health and Care Research