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.
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00242294
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 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)
  Eligibility

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

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
  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: NCT00242294

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

No publications provided

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:
COPD
Phosphodiesterase 4 inhibitor
Roflumilast

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Phosphodiesterase 4 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014