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

This study has been completed.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00242307
First received: October 19, 2005
Last updated: May 4, 2012
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Bronchial Asthma
Drug: Roflumilast
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • change in lung function parameters.

Secondary Outcome Measures:
  • pulmonary function test (spirometry), asthma symptoms, rescue medication, evaluation of QOL, asthma exacerbation, adverse events, pharmacokinetics.

Estimated Enrollment: 450
Study Start Date: May 2004
Study Completion Date: June 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242307

Locations
Japan
Nycomed Japan and Mitsubishi Tanabe Pharma Corporation
Osaka, Japan
Sponsors and Collaborators
Takeda
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Chair: Gerhard Cullmann Nycomed GmbH, 78467 Konstanz, Germany
  More Information

No publications provided

Responsible Party: Nycomed GmbH, Nycomed
ClinicalTrials.gov Identifier: NCT00242307     History of Changes
Other Study ID Numbers: APTA-2217-05
Study First Received: October 19, 2005
Last Updated: May 4, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Takeda:
Asthma
Roflumilast
phosphodiesterase 4 inhibitor

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014