Study identifier:D5896C00021
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A 12-week, randomised, double blind, active-controlled, multi-centre, phase IIIB study comparing the efficacy and safety of SYMBICORT® pMDI 160/4.5 mg x 2 actuations twice daily versus budesonide HFA pMDI 160 mg x 2 actuations twice daily, in adult/adolescent (> 12 yrs) Hispanic subjects with asthma
asthma
Phase 3
No
Budesonide/formoterol (SYMBICORT) pMDI, Budesonide HFA pMDI
All
558
Interventional
12 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.
Location
Location
Aguas Buenas, Puerto Rico
Location
Anaheim, CA, United States
Location
Boerne, TX, United States
Location
Caquas, Puerto Rico
Location
Chicago, IL, United States
Location
Chula Vista, CA, United States
Location
Cidra, Puerto Rico
Location
El Paso, TX, United States
Arms | Assigned Interventions |
---|---|
Active Comparator: Symbicort SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily | Drug: Budesonide/formoterol (SYMBICORT) pMDI SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily |
Active Comparator: Budesonide budesonide HFA pMDI 160 μg x 2 actuations twice daily | Drug: Budesonide HFA pMDI Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily |
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