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

This study has been terminated.
(The decision to terminate was completely related to efficacy and there were no safety concerns.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00263874
First received: December 8, 2005
Last updated: July 20, 2007
Last verified: July 2007
  Purpose

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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: UK-500,001
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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).

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 324
Study Start Date: November 2005
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Valparaíso, 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, 529889
Pfizer Investigational Site
Singapore, Singapore, 308433
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
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00263874     History of Changes
Other Study ID Numbers: A5641009
Study First Received: December 8, 2005
Last Updated: July 20, 2007
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014