Conditions: Asthma
Keywords: Budesonide/Formoterol SPIROMAX® SYMBICORT® TURBOHALER® Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 605
Healthy volunteers: no

Brief summary:
The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.

Detailed description:

Arms:
arm 1: 2 inhalations of BF Spiromax at a dosage of 160/4.5 mcg and 2 inhalations of SYMBICORT placebo administered twice daily (AM and PM) during the 12-week treatment period. arm 2: 2 inhalations of SYMBICORT TURBOHALER at a dosage of 200/6 mcg and 2 inhalations of placebo SPIROMAX administered twice daily (AM and PM) during the 12-week treatment period.

Interventions: intervention 1: Budesonide/Formoterol SPIROMAX® intervention 2: SYMBICORT® TURBOHALER® intervention 3: SYMBICORT placebo intervention 4: SPIROMAX Placebo
Intervention descriptions: intervention 1: BF Spiromax will be administered per dose and schedule specified in the arm. intervention 2: Symbicort Turbohaler will be administered per dose and schedule specified in the arm. intervention 3: SYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm. intervention 4: SPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm.

Protocol document: