Effect of roflumilast on lung function in chronic obstructive pulmonary disease (COPD) patients treated with salmeterol: The EOS Study (BY217/M2-127) - EOS

Study identifier:BY217/M2-127

ClinicalTrials.gov identifier:NCT00313209

EudraCT identifier:2005-005080-28

CTIS identifier:N/A

Study Complete

Official Title

Effect of roflumilast in COPD patients treated with salmeterol. A 24-week, double-blind study with 500 μg roflumilast once daily versus placebo. The EOS Study

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 3

Healthy volunteers

No

Study drug

Roflumilast, Placebo

Sex

All

Actual Enrollment

933

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Apr 2006
Primary Completion Date: 01 Jul 2007
Study Completion Date: 01 Feb 2008

Study design

Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria