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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00242307
Recruitment Status : Completed
First Posted : October 20, 2005
Last Update Posted : November 2, 2016
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Bronchial Asthma Drug: Roflumilast Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)
Study Start Date : May 2004
Primary Completion Date : September 2006
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Roflumilast
U.S. FDA Resources

Primary Outcome Measures :
  1. change in lung function parameters.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242307

Nycomed Japan and Mitsubishi Tanabe Pharma Corporation
Osaka, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00242307     History of Changes
Other Study ID Numbers: APTA-2217-05
First Posted: October 20, 2005    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
phosphodiesterase 4 inhibitor

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases