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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246935
• Other study ID #: APTA-2217-08
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2005
• Last updated: October 24, 2016
• Start date: May 2005
• Est. completion date: October 2007

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Roflumilast

Locations

Country	Name	City	State
Japan	Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) .
Secondary	Efficacy.

External Links

•   APTA-2217-08-RDS-2009-01-16.pdf