Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
Verified date | October 2018 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.
Status | Completed |
Enrollment | 230 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Male or female subjects between, and including, the ages of 40 and 80 years. - Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease, subjects must have had stable disease for at least 1 month prior to screening. - Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up > 6 months ago. Exclusion Criteria: - More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year. - History or presence of significant cardiovascular disease. - ECG abnormalities. - Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study. - Evidence of organ or blood disorders. |
Country | Name | City | State |
---|---|---|---|
Argentina | Pfizer Investigational Site | Buenos Aires | Capital Federal |
Argentina | Pfizer Investigational Site | Buenos Aires | Capital Federal |
Argentina | Pfizer Investigational Site | Ciudad Autonoma de Buenos Aires (CABA) | Capital Federal |
Argentina | Pfizer Investigational Site | La Plata | Buenos Aires |
Argentina | Pfizer Investigational Site | Rosario | Santa Fe |
Australia | Pfizer Investigational Site | Camperdown | New South Wales |
Australia | Pfizer Investigational Site | Daw Park | South Australia |
Australia | Pfizer Investigational Site | Nedlands | Western Australia |
Canada | Pfizer Investigational Site | Hamilton | Ontario |
Canada | Pfizer Investigational Site | Kingston | Ontario |
Canada | Pfizer Investigational Site | Sainte-Foy | Quebec |
Canada | Pfizer Investigational Site | Vancouver | British Columbia |
Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
Chile | Pfizer Investigational Site | Providencia | Santiago, RM |
Chile | Pfizer Investigational Site | Talca | |
Chile | Pfizer Investigational Site | Valparaiso | V Región |
Czechia | Pfizer Investigational Site | Cvikov | |
Czechia | Pfizer Investigational Site | Kutna Hora | |
Czechia | Pfizer Investigational Site | Liberec | |
Czechia | Pfizer Investigational Site | Praha 5 | |
Czechia | Pfizer Investigational Site | Strakonice | |
Czechia | Pfizer Investigational Site | Tabor | |
France | Pfizer Investigational Site | Lille | |
France | Pfizer Investigational Site | Marseille | |
France | Pfizer Investigational Site | Montpellier | |
France | Pfizer Investigational Site | Perpignan | |
Greece | Pfizer Investigational Site | Athens | |
Greece | Pfizer Investigational Site | Heraklion | |
Greece | Pfizer Investigational Site | Larissa | |
Hungary | Pfizer Investigational Site | Budapest | |
Hungary | Pfizer Investigational Site | Budapest | |
Hungary | Pfizer Investigational Site | Deszk | |
Hungary | Pfizer Investigational Site | Pecs | |
Hungary | Pfizer Investigational Site | Szombathely | |
Korea, Republic of | Pfizer Investigational Site | Anyang | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Netherlands | Pfizer Investigational Site | Almere | |
Netherlands | Pfizer Investigational Site | Zutphen | |
Russian Federation | Pfizer Investigational Site | Yaroslavl | |
Russian Federation | Pfizer Investigational Site | Yaroslavl | |
South Africa | Pfizer Investigational Site | Bloemfontein | |
South Africa | Pfizer Investigational Site | Durban | |
South Africa | Pfizer Investigational Site | Durban | Kwa-Zulu Natal |
United Kingdom | Pfizer Investigational Site | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Argentina, Australia, Canada, Chile, Czechia, France, Greece, Hungary, Korea, Republic of, Netherlands, Russian Federation, South Africa, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment. | 6 weeks | ||
Primary | Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment. | 6 weeks | ||
Secondary | Peak expiratory flow rate. | 6 weeks | ||
Secondary | Blood sample for pharmacogenomics | 6 weeks | ||
Secondary | Blood sample for pharmacokinetics | 6 weeks | ||
Secondary | Rescue bronchodilator usage. | 6 weeks | ||
Secondary | Dyspnea index scores. | 6 weeks | ||
Secondary | Global impression of change (patient and clinician). | 6 weeks | ||
Secondary | Symptom scores. | 6 weeks | ||
Secondary | Blood sample for biomarkers | 6 weeks |
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