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

AstraZeneca450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

450

Conditions

Bronchial Asthma

Interventions

RoflumilastDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Nycomed Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, Japan

Outcomes

Primary Outcomes

change in lung function parameters.

Secondary Outcomes

pulmonary function test (spirometry), asthma symptoms, rescue medication, evaluation of QOL, asthma exacerbation, adverse events, pharmacokinetics.

Data from ClinicalTrials.gov

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