Conditions: Asthma
Keywords: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 485
Healthy volunteers: no

Brief summary:
This study is conducted to assess whether training participants on proper use of BF SPIROMAX and Symbicort TURBOHALER will improve their device-handling technique and potentially improve their treatment outcome, that is, better asthma control.

Detailed description:

Arms:
arm 1: Participants will be trained on the proper use of empty Spiromax followed by empty Turbohaler devices. arm 2: Participants will be trained on the proper use of empty Turbohaler followed by empty Spiromax devices. arm 3: Participants who have currently received 800 to 1000 micrograms (μg) beclomethasone-equivalent inhaled corticosteroid (ICS) per day will receive budesonide/formoterol twice daily using the BF Spiromax 160/4.5 device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 640 μg and 18 μg, respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 1280 μg and 36 μg, respectively. arm 4: Participants who have currently received 800 to 1000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 800 μg and 24 μg respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 1600 μg and 48 μg respectively.

Interventions: intervention 1: Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX intervention 2: SYMBICORT TURBOHALER budesonide and formoterol fumarate
Intervention descriptions: intervention 1: SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 μg) intervention 2: SYMBICORT® TURBOHALER® (200/6 and 400/12 μg)

Protocol document: