Multi-centre study to assess the efficacy and safety of AZD5423 in COPD patients on a background therapy of formoterol - -

Study identifier:D2340C00011

ClinicalTrials.gov identifier:NCT01555099

EudraCT identifier:2011-005389-39

CTIS identifier:N/A

Study Complete

Official Title

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.

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

No

Study drug

AZD5423, Budesonide, Placebo

Sex

All

Actual Enrollment

482

Study type

Interventional

Age

40 Years - 150 Years

Date

Study Start Date: 01 Apr 2012
Primary Completion Date: 01 Apr 2013
Study Completion Date: 01 Apr 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2015 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria