A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD

October 12, 2006 updated by: Pfizer

A Multi-Centre, Multinational, Randomized, Double-Blind, Placebo Controlled, Proof Of Concept Trial To Assess The Effects Of A Subject-Optimized Dose Of UK-369,003 On Exercise Capacity In Subjects With Chronic Obstructive Pulmonary Disease

A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

136

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Argentina
      • Buenos Aires, Argentina, 1427
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, 1272
        • Pfizer Investigational Site
      • Ciudad de Beurnos Aires, Argentina, C1425DQi
        • Pfizer Investigational Site
      • Ciudad de Buenos Aires, Argentina, C1115AAB
        • Pfizer Investigational Site
      • Ciudad de Buenos Aires, Argentina, C1416DRV
        • Pfizer Investigational Site
      • Ciudad de Buenos Aires,, Argentina, (C1425DTG)
        • Pfizer Investigational Site
      • Provincia de Buenos Aires, Argentina, (1605)
        • Pfizer Investigational Site
    • Cordoba
      • Ciudad de Cordoba, Cordoba, Argentina, CP 5016
        • Pfizer Investigational Site
    • Pcia de Tucuman
      • San Miguel de Tucuman, Pcia de Tucuman, Argentina, 4000
        • Pfizer Investigational Site
      • San Miguel de Tucuman, Pcia de Tucuman, Argentina
        • Pfizer Investigational Site
    • Santa Fé
      • Rosario, Santa Fé, Argentina, 2000
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Pfizer Investigational Site
      • Darlinghurst, New South Wales, Australia, 2010
        • Pfizer Investigational Site
    • Queensland
      • Chermside,, Queensland, Australia, 4032
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Pfizer Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Pfizer Investigational Site
  • Germany
      • Giessen, Germany, 35392
        • Pfizer Investigational Site
      • Greifestein, Germany, 35753
        • Pfizer Investigational Site
  • India
    • Kerala
      • Cochin, Kerala, India, 682026
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400016
        • Pfizer Investigational Site
      • Pune, Maharashtra, India, 411 019
        • Pfizer Investigational Site
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600116
        • Pfizer Investigational Site
      • Vellore, Tamilnadu, India, 632002
        • Pfizer Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • Pfizer Investigational Site
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Pfizer Investigational Site
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, United Kingdom, CB3 8RE
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • GOLD criteria 2 to 4
  • 10 pack year history of smoking

Exclusion Criteria:

  • Women of child bearing potential

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effect on exercise tolerance

Secondary Outcome Measures

Outcome Measure
Effect on lung function and quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

October 13, 2006

Last Update Submitted That Met QC Criteria

October 12, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3711028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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