Effect of Roflumilast on Exacerbation Rate in Patients with Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

Study identifier:BY217/M2-112

ClinicalTrials.gov identifier:NCT00430729

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Effect of roflumilast on exacerbation rate in patients with chronic obstructive pulmonary disease. A 52 weeks double blind study with 500mcg roflumilast once daily versus placebo. Ratio-Study.

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

No

Study drug

Roflumilast

Sex

All

Actual Enrollment

1100

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Jan 2003
Primary Completion Date: -
Study Completion Date: -

Study design

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

Verification:

Verified 01 Sept 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria