Effect of roflumilast on exacerbation rate in patients with Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)
Study identifier:BY217/M2-125
ClinicalTrials.gov identifier:NCT00297115
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Effect of roflumilast on exacerbation rate in patients with COPD. The HERMES Study
Medical condition
Chronic obstructive pulmonary disease (COPD)
Phase
Phase 3
Healthy volunteers
No
Study drug
Roflumilast, Placebo
Sex
All
Actual Enrollment
1568
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Mar 2006
Primary Completion Date: 01 Apr 2008
Study Completion Date: 01 Aug 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
Location
Altana Pharma/Nycomed Investigational Site
Truro, NS, Canada, B2N 1L2
Location
Altana Pharma/Nycomed Investigational Site
Sainte-Foy, Quebec, Canada, G1V4G5
Location
Altana Pharma/Nycomed Investigational Site
Ste-Foy, QC, Canada, G1W 4R4
Location
Altana Pharma/Nycomed Investigational Site
St. Romuald, QC, Canada, G6W 5M6
Location
Altana Pharma/Nycomed Investigational Site
Montreal, Quebec, Canada, H1V 1X5
Location
Altana Pharma/Nycomed Investigational Site
Montreal, QC, Canada, H3S 2W1
Location
Altana Pharma/Nycomed Investigational Site
Sherbrooke, QC, Canada, J1H 4J6
Location
Altana Pharma/Nycomed Investigational Site
Ottawa, Ontario, Canada, K1Y 4E9
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Roflumilast 500 mcg, once daily, oral administration in the morning | Drug: Roflumilast 500 mcg, once daily, oral administration in the morning |
| Placebo Comparator: Placebo once daily | Drug: Placebo once daily |
Contacts
Contact
AstraZeneca Clinical Study Information Center
Investigators
Principal Investigator
AstraZeneca AstraZeneca
AstraZeneca
