Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

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: NCT00242294
Recruitment Status : Completed
First Posted : October 20, 2005
Last Update Posted : October 26, 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 chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily. The study duration consists of a baseline period (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
Chronic Obstructive Pulmonary Disease (COPD) Drug: Roflumilast Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Confirmatory Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease (A Placebo-controlled Double-blind Comparative Study)
Study Start Date : November 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Roflumilast
U.S. FDA Resources

Primary Outcome Measures :
  1. change in lung function parameters (post-bronchodilator).

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Main inclusion criteria:

  • Patients with chronic obstructive pulmonary disease
  • Current smoker or ex-smoker
  • 30 to 80% of predicted FEV1 after inhalation of short acting beta stimulant

Main exclusion criteria:

  • Patients with poorly controlled COPD
  • Patients who need for long-term oxygen therapy
  • Patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myoma, which are considered to affect the 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): NCT00242294

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

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00242294     History of Changes
Other Study ID Numbers: APTA-2217-06
First Posted: October 20, 2005    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
Phosphodiesterase 4 inhibitor

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases