Anti-Inflammatory Reliever South Africa

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

1,038

Participants

Timeline

Start Date

June 6, 2024

Primary Completion Date

May 28, 2025

Study Completion Date

May 28, 2026

Conditions
Asthma
Interventions
DRUG

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."

DRUG

standard of care

Any therapy that is prescribed as per asthma guidelines i.e. beclomethasone, budesonide and salbutamol, montelukast etc

Trial Locations (2)

3935

Africa Research Health Institute Clinical Trial Unit, Mtubatuba

3965

Africa Research Health Institute Clinical Trial Unit, Mtubatuba

All Listed Sponsors
lead

University of KwaZulu

OTHER