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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014