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

AstraZeneca

Status and phase

Completed

Phase 3

Phase 2

Conditions

Bronchial Asthma

Treatments

Drug: Roflumilast

Study type

Interventional

Funder types

Industry

Identifiers

NCT00242307

APTA-2217-05

Details and patient eligibility

About

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.

Enrollment

450 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion criteria:

Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)
No change in asthma treatment during the last 4 weeks prior to the registration
Non-smokers or ex-smokers for 12 months or more
%FEV1 ranging between 60 and 80%

Main exclusion criteria:

Patients with poorly controlled asthma
Inhalation therapy exceeding low dose during 4 weeks prior to the registration
Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation