Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

Study identifier:ROF-MD-07

ClinicalTrials.gov identifier:NCT01443845

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)

Medical condition

COPD

Phase

Phase 4

Healthy volunteers

No

Study drug

Roflumilast, Placebo

Sex

All

Actual Enrollment

2354

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 30 Sept 2011
Primary Completion Date: 30 Nov 2015
Study Completion Date: 31 Jan 2016

Study design

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

Verification:

Verified 01 Mar 2017 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria