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Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD

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
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
Information provided by:

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)
Estimated 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
Estimated Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo

Secondary Outcome Measures :
  1. 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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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
Pfizer Investigational Site
Santiago, RM, Chile, 7500691
Pfizer Investigational Site
Providencia, Santiago, Chile, 7500691
Pfizer Investigational Site
Valparaíso, Chile, 2381594
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
Pfizer Investigational Site
Debrecen, Hungary, 4004
Pfizer Investigational Site
Torokbalint, Hungary, 2045
Pfizer Investigational Site
Veszprem, Hungary, 8200
Pfizer Investigational Site
Singapore, Singapore, 308433
Pfizer Investigational Site
Singapore, Singapore, 529889
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
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:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes