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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00430729
First received: February 1, 2007
Last updated: May 4, 2012
Last verified: February 2007
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
COPD
Drug: Roflumilast
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Takeda:

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

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

Estimated Enrollment: 1100
Study Start Date: January 2003
Estimated Study Completion Date: October 2004
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Takeda
Investigators
Principal Investigator: Peter MA Calverley, Prof. University Hospital Aintree, UK-Liverpool L97AL
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00430729     History of Changes
Other Study ID Numbers: BY217/M2-112
Study First Received: February 1, 2007
Last Updated: May 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Takeda:
Roflumilast

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

ClinicalTrials.gov processed this record on July 31, 2014