Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

AstraZeneca150 enrolled

Overview

The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is an extension of the 24-week study APTA-2217-06 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Roflumilast

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Main inclusion criteria: * Patients with chronic obstructive pulmonary disease (COPD) * Written informed consent * Patients who completed the 24-week evaluation of study APTA-2217-06 Main exclusion criteria: * If patients required hospitalization or received emergency care for COPD exacerbation by the investigator (or sub-investigator) between the informed consent day and the starting day * Patients with long-term oxygen therapy * Serious diseases

Locations (1)

Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, Japan

Outcomes

Primary Outcomes

Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) .

Secondary Outcomes

Efficacy.

Data from ClinicalTrials.gov

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