Study identifier:D2340C00011
ClinicalTrials.gov identifier:NCT01555099
EudraCT identifier:2011-005389-39
CTIS identifier:N/A
A phase-II, double-blind, placebo-controlled, randomised, parallel-group,multi-centre study to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.
Chronic obstructive pulmonary disease (COPD)
Phase 2
No
AZD5423, Budesonide, Placebo
All
482
Interventional
40 Years - 150 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2015 by AstraZeneca
AstraZeneca
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The purpose of the study is to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.
A phase-II, double-blind, placebo-controlled, randomised, parallel-group,multi-centre study to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.
Location
Location
Sofia, Bulgaria
Location
Doganovo, Bulgaria
Location
Plovdiv, Bulgaria
Location
Varna, Bulgaria
Location
Montpellier, France
Location
Marseille Cedex 20, France
Location
Pessac, France
Location
Brest Cedex 2, France
Arms | Assigned Interventions |
---|---|
Experimental: AZD5423 New study drug | Drug: AZD5423 oral inhaled Other Name: AZD5423 |
Active Comparator: Budesonide Comparator to which the new study drug will be compared | Drug: Budesonide oral inhaled Other Name: Budesonide |
Placebo Comparator: Placebo No drug to which both other arms will be compared | Drug: Placebo oral inhaled Other Name: Placebo |
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