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

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Roflumilast

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma

Outcomes

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

Full Information

First Posted
February 1, 2007
Last Updated
November 29, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00430729
Brief Title
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD
Keywords
Roflumilast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Roflumilast
Primary Outcome Measure Information:
Title
The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.
Title
Change in FEV1 from baseline during the treatment period.
Secondary Outcome Measure Information:
Title
Pulmonary function variables; quality of life variables;patient diary variables;safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
ALTANA Pharma
City
Cities in Australia
Country
Australia
Facility Name
ALTANA Pharma
City
Cities in Austria
Country
Austria
Facility Name
ALTANA Pharma
City
Cities in Canada
Country
Canada
Facility Name
ALTANA Pharma
City
Cities in France
Country
France
Facility Name
ALTANA Pharma
City
Cities in Hungary
Country
Hungary
Facility Name
ALTANA Pharma
City
Cities in Italy
Country
Italy
Facility Name
ALTANA Pharma
City
Cities in the Netherlands
Country
Netherlands
Facility Name
ALTANA Pharma
City
Cities in Poland
Country
Poland
Facility Name
ALTANA Pharma
City
Cities in Portugal
Country
Portugal
Facility Name
ALTANA Pharma
City
Cities in the Russian Federation
Country
Russian Federation
Facility Name
ALTANA Pharma
City
Cities in South Africa
Country
South Africa
Facility Name
ALTANA Pharma
City
Cities in Spain
Country
Spain
Facility Name
ALTANA Pharma
City
Cities in Switzerland
Country
Switzerland
Facility Name
ALTANA Pharma
City
Cities in the United Kingdom
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28419462
Citation
Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
Results Reference
derived
PubMed Identifier
21272339
Citation
Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4478&filename=BY217-M2-112-RDS-2005-05-11.pdf
Description
BY217-M2-112-RDS-2005-05-11.pdf

Learn more about this trial

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

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