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

AstraZeneca

Status and phase

Completed

Phase 3

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Roflumilast

Study type

Interventional

Funder types

Industry

Identifiers

NCT00242294

APTA-2217-06

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 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.

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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