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Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

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ClinicalTrials.gov Identifier: NCT00430729
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease COPD Drug: Roflumilast Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.
Study Start Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Roflumilast
U.S. FDA Resources




Primary Outcome Measures :
  1. The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.
  2. Change in FEV1 from baseline during the treatment period.

Secondary Outcome Measures :
  1. Pulmonary function variables; quality of life variables;patient diary variables;safety


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • FEV1/FVC ratio (post-bronchodilator) ≤70%
  • FEV1 (post-bronchodilator) ≤50% of predicted
  • Current smoker or ex-smoker
  • Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
  • Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before baseline

Main Exclusion Criteria:

  • COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
  • Lower respiratory tract infection not resolved 4 weeks prior to baseline
  • Diagnosis of asthma and/or other relevant lung disease
  • Known alpha-1-antitrypsin deficiency
  • Need for long-term oxygen therapy defined as ≥16 hours/day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430729


Locations
Australia
ALTANA Pharma
Cities in Australia, Australia
Austria
ALTANA Pharma
Cities in Austria, Austria
Canada
ALTANA Pharma
Cities in Canada, Canada
France
ALTANA Pharma
Cities in France, France
Hungary
ALTANA Pharma
Cities in Hungary, Hungary
Italy
ALTANA Pharma
Cities in Italy, Italy
Netherlands
ALTANA Pharma
Cities in the Netherlands, Netherlands
Poland
ALTANA Pharma
Cities in Poland, Poland
Portugal
ALTANA Pharma
Cities in Portugal, Portugal
Russian Federation
ALTANA Pharma
Cities in the Russian Federation, Russian Federation
South Africa
ALTANA Pharma
Cities in South Africa, South Africa
Spain
ALTANA Pharma
Cities in Spain, Spain
Switzerland
ALTANA Pharma
Cities in Switzerland, Switzerland
United Kingdom
ALTANA Pharma
Cities in the United Kingdom, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00430729     History of Changes
Other Study ID Numbers: BY217/M2-112
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
Roflumilast

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases