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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchial Asthma

Keywords

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Asthma Roflumilast phosphodiesterase 4 inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Roflumilast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with asthma disease
* Written informed consent
* Patients who completed the 24-week evaluation of study APTA-2217-05

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Nycomed Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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APTA-2217-07

Identifier Type: -

Identifier Source: org_study_id