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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00430300 |
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive |
Drug: UK-432,097 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group Study To Evaluate the Efficacy And Safety of UK-432,097 Dry Powder For Inhalation In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease. |
Enrollment: | 71 |
Study Start Date: | January 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
150mcg, 450mcg or 1350mcg: Experimental
Active treatment given BID via a double pin monodose capsule inhaler device
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Drug: UK-432,097
Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.
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Placebo: Placebo Comparator
Placebo treatment given BID via a single pin monodose inhaler device
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Drug: Placebo
Capsules containing 100% lactose administered BID using an atomizer device
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Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
Pfizer Investigational Site | |
Camperdown, New South Wales, Australia, 2050 | |
Pfizer Investigational Site | |
Glebe, New South Wales, Australia, 2037 | |
Australia, South Australia | |
Pfizer Investigational Site | |
Daw Park, South Australia, Australia, 5041 | |
Australia, Western Australia | |
Pfizer Investigational Site | |
Nedlands, Western Australia, Australia, 6009 | |
Canada, Alberta | |
Pfizer Investigational Site | |
Calgary, Alberta, Canada, T1Y 6J4 | |
Pfizer Investigational Site | |
Red Deer, Alberta, Canada, T4N 6V7 | |
Canada, Ontario | |
Pfizer Investigational Site | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Canada, Quebec | |
Pfizer Investigational Site | |
Québec, Quebec, Canada, G1V 4G5 | |
Pfizer Investigational Site | |
Trois-Rivières, Quebec, Canada, G8T 7A1 | |
Netherlands | |
Pfizer Investigational Site | |
Eindhoven, Netherlands, 5623 EJ | |
Pfizer Investigational Site | |
Zuthpen, Netherlands, 7207 BA | |
Pfizer Investigational Site | |
Almelo, Netherlands, 7609 PP | |
Poland | |
Pfizer Investigational Site | |
Gdansk, Poland, 80-952 | |
Pfizer Investigational Site | |
Warszawa, Poland, 01-138 | |
Pfizer Investigational Site | |
Bydgoszcz, Poland, 85-326 | |
Pfizer Investigational Site | |
Lodz, Poland, 90-153 | |
United Kingdom | |
Pfizer Investigational Site | |
Newcastle upon Tyne, United Kingdom, NE7 7DN | |
Pfizer Investigational Site | |
Manchester, United Kingdom, M23 QZ | |
Pfizer Investigational Site | |
Leicester, United Kingdom, LE3 9QP | |
Pfizer Investigational Site | |
London, United Kingdom, E2 9ZY | |
Pfizer Investigational Site | |
Southampton, United Kingdom, SO16 6YD | |
United Kingdom, Surrey | |
Pfizer Investigational Site | |
Chertsey, Surrey, United Kingdom, KT16 0PZ |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3971013 |
Study First Received: | January 30, 2007 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00430300 |
Health Authority: | United States: Food and Drug Administration |
Dry Powder for Inhalation, Chronic Obstructive Pulmonary Disease, Lung Function testing |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Chronic Disease Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes |