A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg - CHASE 3
Study identifier:D589GC00003
ClinicalTrials.gov identifier:NCT02091986
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Symbicort pMDI
Sex
All
Actual Enrollment
882
Study type
Interventional
Age
6 Years - 11 Years
Date
Study Start Date: 01 Apr 2014
Primary Completion Date: 01 Apr 2016
Study Completion Date: 01 Apr 2016
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Symbicort pMDI 80/2.25 µg Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily | Drug: Symbicort pMDI Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily |
| Active Comparator: Symbicort pMDI 80/4.5µg Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily | Drug: Symbicort pMDI Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily |
| Active Comparator: Budesonide pMDI Budesonide pMDI 80µg, 2 acuations twice daily | Other: Budesonide pMDI Budesonide pMDI 80µg, 2 acuations twice daily Other Name: Active comparator |
Contacts
Investigators
Principal Investigator
David S Pearlman
Colorado Allergy Asthma Centers, PC, US
