Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease - TREAT

Study identifier:RO-2455-405-RD

ClinicalTrials.gov identifier:NCT01473758

EudraCT identifier:2011-002905-31

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

Effect of Roflumilast 500 μg Tablets Once Daily at Acute COPD Exacerbations Treated with Standard Therapy of Oral Steroids and Antibiotics. A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial

Medical condition

Chronic Obstructive Pulmonary Disease with (Acute) Exacerbation

Phase

Phase 2

Healthy volunteers

No

Study drug

Roflumilast, Placebo

Sex

All

Actual Enrollment

81

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Feb 2012
Primary Completion Date: 01 Mar 2014
Study Completion Date: 01 Mar 2014

Study design

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

Verification:

Verified 01 Dec 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria