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COMPLETED
NCT00242307
PHASE2/PHASE3

Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

Official title: A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)

Key Details

Gender

All

Age Range

20 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2004-05-01

Completion Date

2007-06-01

Last Updated

2026-06-10

Healthy Volunteers

Not specified

Interventions

DRUG

Roflumilast

Locations (1)

Nycomed Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, Japan