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

AstraZeneca150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Bronchial Asthma

Interventions

RoflumilastDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 71 Years

Medical Language ↔ Plain English

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

Locations (1)

Nycomed Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, Japan

Outcomes

Primary Outcomes

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 Outcomes

Efficacy.

Data from ClinicalTrials.gov

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