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

December 8, 2005
July 20, 2007
November 2005
Not Provided
Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
Change from baseline in FEV1 compared to placebo
Complete list of historical versions of study NCT00263874 on ClinicalTrials.gov Archive Site
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
Same as current
Not Provided
Not Provided
 
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).

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Drug: UK-500,001
Not Provided
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. Epub 2009 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
324
September 2006
Not Provided

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   Chile,   Croatia,   Czech Republic,   Hungary,   Singapore,   Spain,   United Kingdom
 
NCT00263874
A5641009
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP