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

  Show 28 Study Locations
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 17, 2014