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

This study has been completed.
Mitsubishi Tanabe Pharma Corporation
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ClinicalTrials.gov Identifier:
First received: October 19, 2005
Last updated: May 4, 2012
Last verified: December 2008
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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
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 Patients With Chronic Obstructive Pulmonary Disease (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 (post-bronchodilator).

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

Estimated Enrollment: 570
Study Start Date: November 2004
Study Completion Date: March 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00242294

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

Responsible Party: Nycomed GmbH, Nycomed
ClinicalTrials.gov Identifier: NCT00242294     History of Changes
Other Study ID Numbers: APTA-2217-06 
Study First Received: October 19, 2005
Last Updated: May 4, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Takeda:
Phosphodiesterase 4 inhibitor

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

ClinicalTrials.gov processed this record on May 26, 2016