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NCT00246922 Clinical Trial

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)

Bronchial Asthma Clinical Trial

Official title:
A Long-term Study of APTA-2217 in Adult Patients With Bronchial Asthma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00246922
Other study ID # APTA-2217-07
Secondary ID
Status Completed
Phase Phase 3
First received October 31, 2005
Last updated December 1, 2016
Start date December 2004
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 asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (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 20 Years to 71 Years
Eligibility Main inclusion criteria:

- Patients with asthma disease

- Written informed consent

- Patients who completed the 24-week evaluation of study APTA-2217-05

Main exclusion criteria:

- % FEV1.0 < 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05

- Patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, PEF value worsened for 2 or more consecutive days

- Serious diseases

Study Design

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

Related Conditions & MeSH terms

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 Long-term safety after 28 weeks treatment of Roflumilast at (total 52 weeks, 24 weeks of study APTA-2217-05 followed by 28 weeks) .
Secondary Efficacy.
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