Study identifier:D589SC00001
ClinicalTrials.gov identifier:NCT02149199
EudraCT identifier:2013-004474-96
CTIS identifier:N/A
A clinical study comparing Symbicort® ‘as needed’ with terbutaline ‘as needed’ and with Pulmicort® twice daily plus terbutaline ‘as needed’ in adult and adolescent patients with asthma.
asthma
Phase 3
No
budesonide/formoterol 'as needed' + budesonide placebo bid, terbutaline 'as needed' + placebo budesonide bid, budesonide bid + terbutaline 'as needed'
All
3850
Interventional
12 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2019 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Symbicort "as needed"+placebo Pulmicort bid Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid | Drug: budesonide/formoterol 'as needed' + budesonide placebo bid Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment |
Active Comparator: terbutaline "as needed"+placebo Pulmicort bid terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler bid | Drug: terbutaline 'as needed' + placebo budesonide bid Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment |
Active Comparator: Pulmicort bid + terbutaline "as needed" Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed' | Drug: budesonide bid + terbutaline 'as needed' Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment |