Back to resultsEfficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Phosphodiesterase 4 inhibitor, Roflumilast
Eligibility Criteria
Main inclusion criteria: Patients with chronic obstructive pulmonary disease Current smoker or ex-smoker 30 to 80% of predicted FEV1 after inhalation of short acting beta stimulant Main exclusion criteria: Patients with poorly controlled COPD Patients who need for long-term oxygen therapy Patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myoma, which are considered to affect the evaluation
Sites / Locations
- Nycomed Japan and Mitsubishi Tanabe Oharma Corporation
Outcomes
Primary Outcome Measures
change in lung function parameters (post-bronchodilator).
Secondary Outcome Measures
pulmonary function test, COPD symptoms, rescue medication, evaluation of QOL, COPD exacerbation, adverse events, pharmacokinetics.
Full Information
NCT ID
NCT00242294
First Posted
October 19, 2005
Last Updated
October 24, 2016
Sponsor
AstraZeneca
Collaborators
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00242294
Brief Title
Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)
Official Title
A Confirmatory Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease (A Placebo-controlled Double-blind Comparative Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
Brief Summary
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily. The study duration consists of a baseline period (4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
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
COPD, Phosphodiesterase 4 inhibitor, Roflumilast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
570 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Primary Outcome Measure Information:
Title
change in lung function parameters (post-bronchodilator).
Secondary Outcome Measure Information:
Title
pulmonary function test, COPD symptoms, rescue medication, evaluation of QOL, COPD exacerbation, adverse events, pharmacokinetics.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Eligibility Criteria
Main inclusion criteria:
Patients with chronic obstructive pulmonary disease
Current smoker or ex-smoker
30 to 80% of predicted FEV1 after inhalation of short acting beta stimulant
Main exclusion criteria:
Patients with poorly controlled COPD
Patients who need for long-term oxygen therapy
Patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myoma, which are considered to affect the evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Nycomed Japan and Mitsubishi Tanabe Oharma Corporation
City
Osaka
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4466&filename=APTA-2217-06-RDS-2008-12-05.pdf
Description
APTA-2217-06-RDS-2008-12-05.pdf
Learn more about this trial
Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)
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