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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:
ClinicalTrials.gov Identifier:
NCT00242294
First Posted: October 20, 2005
Last Update Posted: October 26, 2016
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.
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
AstraZeneca
  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
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 AstraZeneca:

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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00242294


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00242294     History of Changes
Other Study ID Numbers: APTA-2217-06
First Submitted: October 19, 2005
First Posted: October 20, 2005
Last Update Posted: October 26, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
COPD
Phosphodiesterase 4 inhibitor
Roflumilast

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