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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

A Confirmatory Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease (A Placebo-controlled Double-blind Comparative Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242294
• Other study ID #: APTA-2217-06
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 19, 2005
• Last updated: October 24, 2016
• Start date: November 2004
• Est. completion date: March 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: March 2007
• Est. primary completion date: September 2006
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

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 Japan and Mitsubishi Tanabe Oharma 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	change in lung function parameters (post-bronchodilator).
Secondary	pulmonary function test, COPD symptoms, rescue medication, evaluation of QOL, COPD exacerbation, adverse events, pharmacokinetics.

External Links

•   APTA-2217-06-RDS-2008-12-05.pdf