Study Stopped
The decision to terminate was completely related to efficacy and there were no safety concerns.
Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD
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).
1 other identifier
interventional
324
10 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2005
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 8, 2005
CompletedFirst Posted
Study publicly available on registry
December 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJuly 23, 2007
July 1, 2007
December 8, 2005
July 20, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
Secondary Outcomes (1)
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
Interventions
Eligibility Criteria
You may qualify if:
- Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition)
- Smoking history of at least 10 pack-years
You may not qualify if:
- Any significant co-morbid disease
- Use of any maintenance therapy except short acting bronchodilators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (28)
Pfizer Investigational Site
La Plata, Buenos Aires, C1904AGP, Argentina
Pfizer Investigational Site
Vicente López, Buenos Aires, 1602, Argentina
Pfizer Investigational Site
Rosario, Santa Fé, 2000, Argentina
Pfizer Investigational Site
Buenos Aires, 1426, Argentina
Pfizer Investigational Site
Buenos Aires, C1425DQU, Argentina
Pfizer Investigational Site
Camperdown, New South Wales, 2050, Australia
Pfizer Investigational Site
Clayton, Victoria, 3168a, Australia
Pfizer Investigational Site
Nedlands, Western Australia, 6009, Australia
Pfizer Investigational Site
Calgary, Alberta, T1Y 6J4, Canada
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7, Canada
Pfizer Investigational Site
Hamilton, Ontario, L8N 3Z5, Canada
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7, Canada
Pfizer Investigational Site
Santiago, RM, 7500691, Chile
Pfizer Investigational Site
Providencia, Santiago Metropolitan, 7500691, Chile
Pfizer Investigational Site
ValparaÃ-so, ValparaÃ-so, 2381594, Chile
Pfizer Investigational Site
Zagreb, 10000, Croatia
Pfizer Investigational Site
Olomouc, 775 20, Czechia
Pfizer Investigational Site
Ostrava-Poruba, 708 52, Czechia
Pfizer Investigational Site
Prague, 150 06, Czechia
Pfizer Investigational Site
Tábor, 390 03, Czechia
Pfizer Investigational Site
Debrecen, 4004, Hungary
Pfizer Investigational Site
Törökbálint, 2045, Hungary
Pfizer Investigational Site
Veszprém, 8200, Hungary
Pfizer Investigational Site
Singapore, 308433, Singapore
Pfizer Investigational Site
Singapore, 529889, Singapore
Pfizer Investigational Site
Madrid, Madrid, 28007, Spain
Pfizer Investigational Site
Madrid, Madrid, 28046, Spain
Pfizer Investigational Site
Manchester, M23 9LT, United Kingdom
Related Publications (1)
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.
PMID: 19213793DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 8, 2005
First Posted
December 9, 2005
Study Start
November 1, 2005
Study Completion
September 1, 2006
Last Updated
July 23, 2007
Record last verified: 2007-07