Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125) - Full Text View

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00297115

Purpose

The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Roflumilast	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Roflumilast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

exacerbation rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
FEV1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

other spirometry parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
COPD symptoms [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
safety and tolerability of roflumilast [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1500
Study Start Date:	February 2006
Study Completion Date:	August 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Roflumilast 500 mcg	Drug: Roflumilast Effect of Roflumilast on exacerbation rate in patients with COPD
2: Placebo Comparator Placebo	Drug: Roflumilast Effect of Roflumilast on exacerbation rate in patients with COPD

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

COPD patients having at least one exacerbation within last year
FEV1/FVC ratio (post-bronchodilator) ≤ 70%
FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

COPD exacerbation not resolved at first baseline visit
Diagnosis of asthma and/or other relevant lung disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297115

Show 288 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Fernando J. Martinez, MD, MS

University of Michigan Health System, 3916 Taubman Center, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-0360, USA

More Information

Responsible Party:	Nycomed ( Nycomed )
Study ID Numbers:	BY217/M2-125
Study First Received:	February 27, 2006
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00297115
Health Authority:	United States: Food and Drug Administration

Keywords provided by ALTANA Pharma:

Roflumilast
COPD
Chronic obstructive pulmonary disease

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 15, 2009