Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

Sponsor
AstraZeneca
Study ID
NCT00242294
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 30, 2004
Status verified
Sep 2016
Primary completion
Sep 30, 2006
Completion
Mar 31, 2007

Study Design

Enrollment
570 participants
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

change in lung function parameters (post-bronchodilator).

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