Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Confirmatory Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease (A Placebo-controlled Double-blind Comparative Study)
Verified date | September 2016 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 570 |
Est. completion date | March 2007 |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Nycomed Japan and Mitsubishi Tanabe Oharma Corporation | Osaka |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Mitsubishi Tanabe Pharma Corporation |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in lung function parameters (post-bronchodilator). | |||
Secondary | pulmonary function test, COPD symptoms, rescue medication, evaluation of QOL, COPD exacerbation, adverse events, pharmacokinetics. |
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