Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)

Bronchial Asthma Clinical Trial

Official title:

A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242307
• Other study ID #: APTA-2217-05
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 19, 2005
• Last updated: October 31, 2016
• Start date: May 2004
• Est. completion date: June 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 asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 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: 450
• Est. completion date: June 2007
• Est. primary completion date: September 2006
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Main inclusion criteria:

• Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)

• No change in asthma treatment during the last 4 weeks prior to the registration

• Non-smokers or ex-smokers for 12 months or more

• %FEV1 ranging between 60 and 80%

Main exclusion criteria:

• Patients with poorly controlled asthma

• Inhalation therapy exceeding low dose during 4 weeks prior to the registration

• Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation

Study Design

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Roflumilast

Locations

Country	Name	City	State
Japan	Nycomed 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	change in lung function parameters.
Secondary	pulmonary function test (spirometry), asthma symptoms, rescue medication, evaluation of QOL, asthma exacerbation, adverse events, pharmacokinetics.

External Links

•   APTA-2217-05-RDS-2008-12-17.pdf