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

July 20, 2007 updated by: Pfizer

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).

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.

Study Overview

Status

Terminated

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention / Treatment

Drug: UK-500,001

Study Type

Interventional

Enrollment

324

Phase

Phase 2

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

Argentina
- - Buenos Aires, Argentina, 1426
    - Pfizer Investigational Site
  - Buenos Aires, Argentina, C1425DQU
    - Pfizer Investigational Site
- Buenos Aires
  - La Plata, Buenos Aires, Argentina, C1904AGP
    - Pfizer Investigational Site
  - Vicente Lopez, Buenos Aires, Argentina, 1602
    - Pfizer Investigational Site
- Santa FÃ©
  - Rosario, Santa FÃ©, Argentina, 2000
    - Pfizer Investigational Site
Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Pfizer Investigational Site
- Victoria
  - Clayton, Victoria, Australia, 3168a
    - Pfizer Investigational Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Pfizer Investigational Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T1Y 6J4
    - Pfizer Investigational Site
  - Red Deer, Alberta, Canada, T4N 6V7
    - Pfizer Investigational Site
- Ontario
  - Hamilton, Ontario, Canada, L8N 3Z5
    - Pfizer Investigational Site
  - Kingston, Ontario, Canada, K7L 2V7
    - Pfizer Investigational Site
Chile
- - ValparaÃ-so, Chile, 2381594
    - Pfizer Investigational Site
- RM
  - Santiago, RM, Chile, 7500691
    - Pfizer Investigational Site
- Santiago
  - Providencia, Santiago, Chile, 7500691
    - Pfizer Investigational Site
Croatia
- - Zagreb, Croatia, 10000
    - Pfizer Investigational Site
Czech Republic
- - 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
Hungary
- - Debrecen, Hungary, 4004
    - Pfizer Investigational Site
  - Torokbalint, Hungary, 2045
    - Pfizer Investigational Site
  - Veszprem, Hungary, 8200
    - Pfizer Investigational Site
Singapore
- - Singapore, Singapore, 529889
    - Pfizer Investigational Site
  - Singapore, Singapore, 308433
    - Pfizer Investigational Site
Spain
- - Madrid, Spain, 28007
    - Pfizer Investigational Site
  - Madrid, Spain, 28046
    - Pfizer Investigational Site
United Kingdom
- - Manchester, United Kingdom, M23 9LT
    - 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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

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
Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo

Secondary Outcome Measures

Outcome Measure
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo

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.

General Publications

Vestbo J, Tan L, Atkinson G, Ward J; UK-500,001 Global Study Team. A controlled trial of 6-weeks' treatment with a novel inhaled phosphodiesterase type-4 inhibitor in COPD. Eur Respir J. 2009 May;33(5):1039-44. doi: 10.1183/09031936.00068908. Epub 2009 Feb 12.

Helpful Links

To obtain contact information for a study center near you, click here.

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

November 1, 2005

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

December 8, 2005

First Posted (Estimate)

December 9, 2005

Study Record Updates

Last Update Posted (Estimate)

July 23, 2007

Last Update Submitted That Met QC Criteria

July 20, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A5641009

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.