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

AstraZeneca1 个研究点分布在 1 个国家目标入组 570 人开始时间: 2004年11月1日最近更新: 2016年10月26日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: AstraZeneca
入组人数: 570
试验地点: 1
主要终点: change in lung function parameters (post-bronchodilator).

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

结局指标

主要结局

change in lung function parameters (post-bronchodilator).

次要结局

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

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

已完成

2 期

Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).Bronchial Asthma

NCT00242307AstraZeneca450

已完成

3 期

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07).Bronchial Asthma

NCT00246922AstraZeneca150

已完成

3 期

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)Chronic Obstructive Pulmonary Disease (COPD)

NCT00246935AstraZeneca150

已完成

3 期

The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)Chronic Obstructive Pulmonary Disease, COPD

NCT00108823AstraZeneca550

已完成

3 期

Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)Chronic Obstructive Pulmonary Disease (COPD)

NCT00313209AstraZeneca933