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.)
Information provided by:
Pfizer Identifier:
First received: December 8, 2005
Last updated: July 20, 2007
Last verified: July 2007
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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00263874

  Show 28 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by Identifier (NCT Number): 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
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases processed this record on November 27, 2015