1,038
Participants
Start Date
June 6, 2024
Primary Completion Date
May 28, 2025
Study Completion Date
May 28, 2026
Budesonide/formoterol
"The Investigational Medicinal Product (IMP) consists of a combination of Budesonide (corticosteroid) and Formoterol Furamate (fast-acting β2 agonist) dihydrate. The IMP is currently available and registered in dry powder form turbuhaler (Symbicort) and a pressurised metered dose inhaler (Vannair).~The recommended doses are pMDI/DPI 80/4.5 1-2 puffs twice daily OR 1 puff as needed (a maximum daily dose of 8 puffs) for children 6-11 years of age and 160/4.5 1-2 inhalations twice daily or 1 puff as needed (a maximum daily dose of 12 puffs) for adolescents 12-18 years."
standard of care
Any therapy that is prescribed as per asthma guidelines i.e. beclomethasone, budesonide and salbutamol, montelukast etc
Africa Research Health Institute Clinical Trial Unit, Mtubatuba
Africa Research Health Institute Clinical Trial Unit, Mtubatuba
University of KwaZulu
OTHER