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OpenTrials
Completed

NCT Number: NCT00242294

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nycomed Japan and Mitsubishi Tanabe Oharma Corporation

Osaka, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roflumilast

Drug

Primary outcomes

  1. change in lung function parameters (post-bronchodilator).

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Tanabe Pharma Corporation

Registry information

Official study title

A Confirmatory Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease (A Placebo-controlled Double-blind Comparative Study)

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Oct 20, 2005
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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