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

A Long-term Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00246935

Enrollment

150

Registered

2005-11-01

Start date

2005-05-31

Completion date

2007-10-31

Last updated

2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, Phosphodiesterase 4 inhibitor, Roflumilast

Brief summary

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.

Interventions

DRUGRoflumilast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Efficacy.	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026