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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UK-500,001
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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

Full Information

First Posted
December 8, 2005
Last Updated
July 20, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00263874
Brief Title
Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD
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).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Terminated
Why Stopped
The decision to terminate was completely related to efficacy and there were no safety concerns.
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
324 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
UK-500,001
Primary Outcome Measure Information:
Title
Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
Secondary Outcome Measure Information:
Title
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
C1904AGP
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Vicente Lopez
State/Province
Buenos Aires
ZIP/Postal Code
1602
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Rosario
State/Province
Santa Fé
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1425DQU
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Pfizer Investigational Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168a
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
ZIP/Postal Code
7500691
Country
Chile
Facility Name
Pfizer Investigational Site
City
Providencia
State/Province
Santiago
ZIP/Postal Code
7500691
Country
Chile
Facility Name
Pfizer Investigational Site
City
ValparaÃ-so
ZIP/Postal Code
2381594
Country
Chile
Facility Name
Pfizer Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Tabor
ZIP/Postal Code
390 03
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19213793
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5641009&StudyName=Phase+2+Study+of+the+Safety+and+Efficacy+of+UK%2D500%2C001+in+Adult+Patients+with+COPD
Description
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Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD

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