Effect of roflumilast in chronic obstructive pulmonary disease (COPD) patients treated with tiotropium: The HELIOS Study (BY217/M2-128) - HELIOS

Study identifier:BY217/M2-128

ClinicalTrials.gov identifier:NCT00424268

EudraCT identifier:2006-004508-37

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

No

Study drug

Roflumilast, Placebo

Sex

All

Actual Enrollment

743

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Jan 2007
Primary Completion Date: 01 Jan 2008
Study Completion Date: 01 Jul 2008

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