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Completed

NCT Number: NCT00242307

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

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.

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Key information

Conditions

Bronchial Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nycomed Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roflumilast

Drug

Primary outcomes

  1. change in lung function parameters.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Tanabe Pharma Corporation

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Oct 20, 2005
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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