Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of UK-500,001 Dry Powder For Inhalation (DPI) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
| Verified date | July 2007 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease.
| Status | Terminated |
| Enrollment | 324 |
| Est. completion date | September 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition) - Smoking history of at least 10 pack-years Exclusion Criteria: - Any significant co-morbid disease - Use of any maintenance therapy except short acting bronchodilators |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | La Plata | Buenos Aires |
| Argentina | Pfizer Investigational Site | Rosario | Santa Fé |
| Argentina | Pfizer Investigational Site | Vicente Lopez | Buenos Aires |
| Australia | Pfizer Investigational Site | Camperdown | New South Wales |
| Australia | Pfizer Investigational Site | Clayton | Victoria |
| Australia | Pfizer Investigational Site | Nedlands | Western Australia |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Hamilton | Ontario |
| Canada | Pfizer Investigational Site | Kingston | Ontario |
| Canada | Pfizer Investigational Site | Red Deer | Alberta |
| Chile | Pfizer Investigational Site | Providencia | Santiago |
| Chile | Pfizer Investigational Site | Santiago | RM |
| Chile | Pfizer Investigational Site | ValparaÃso | |
| Croatia | Pfizer Investigational Site | Zagreb | |
| Czech Republic | Pfizer Investigational Site | Olomouc | |
| Czech Republic | Pfizer Investigational Site | Ostrava-Poruba | |
| Czech Republic | Pfizer Investigational Site | Praha 5 | |
| Czech Republic | Pfizer Investigational Site | Tabor | |
| Hungary | Pfizer Investigational Site | Debrecen | |
| Hungary | Pfizer Investigational Site | Torokbalint | |
| Hungary | Pfizer Investigational Site | Veszprem | |
| Singapore | Pfizer Investigational Site | Singapore | |
| Singapore | Pfizer Investigational Site | Singapore | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| United Kingdom | Pfizer Investigational Site | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Argentina, Australia, Canada, Chile, Croatia, Czech Republic, Hungary, Singapore, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo | |||
| Secondary | Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo |
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