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Completed

NCT Number: NCT00246922

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

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.

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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–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nycomed Japan and Mitsubishi Tanabe Pharma Corporation

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Roflumilast

Drug

Primary outcomes

  1. 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

  1. Efficacy.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Tanabe Pharma Corporation

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Nov 1, 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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