Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00263874 |
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Recruitment Status :
Terminated
(The decision to terminate was completely related to efficacy and there were no safety concerns.)
First Posted : December 9, 2005
Last Update Posted : July 23, 2007
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Sponsor:
Pfizer
Information provided by:
Pfizer
- Study Details
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Disease, Chronic Obstructive | Drug: UK-500,001 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 324 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| 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). |
| Study Start Date : | November 2005 |
| Study Completion Date : | September 2006 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
Secondary Outcome Measures :
- Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263874
Hide Study Locations
Locations
| Argentina | |
| Pfizer Investigational Site | |
| La Plata, Buenos Aires, Argentina, C1904AGP | |
| Pfizer Investigational Site | |
| Vicente Lopez, Buenos Aires, Argentina, 1602 | |
| Pfizer Investigational Site | |
| Rosario, Santa Fé, Argentina, 2000 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1426 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, C1425DQU | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Camperdown, New South Wales, Australia, 2050 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Clayton, Victoria, Australia, 3168a | |
| 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 | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Chile | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile, 7500691 | |
| Pfizer Investigational Site | |
| Providencia, Santiago, Chile, 7500691 | |
| Pfizer Investigational Site | |
| ValparaÃso, Chile, 2381594 | |
| Croatia | |
| Pfizer Investigational Site | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Olomouc, Czech Republic, 775 20 | |
| Pfizer Investigational Site | |
| Ostrava-Poruba, Czech Republic, 708 52 | |
| Pfizer Investigational Site | |
| Praha 5, Czech Republic, 150 06 | |
| Pfizer Investigational Site | |
| Tabor, Czech Republic, 390 03 | |
| Hungary | |
| Pfizer Investigational Site | |
| Debrecen, Hungary, 4004 | |
| Pfizer Investigational Site | |
| Torokbalint, Hungary, 2045 | |
| Pfizer Investigational Site | |
| Veszprem, Hungary, 8200 | |
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 308433 | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 529889 | |
| Spain | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28007 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28046 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M23 9LT | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00263874 History of Changes |
| Other Study ID Numbers: |
A5641009 |
| First Posted: | December 9, 2005 Key Record Dates |
| Last Update Posted: | July 23, 2007 |
| Last Verified: | July 2007 |
Additional relevant MeSH terms:
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Lung Diseases Pulmonary Disease, Chronic Obstructive Chronic Disease Respiratory Tract Diseases |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes |