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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00263874
Recruitment Status : Terminated (The decision to terminate was completely related to efficacy and there were no safety concerns.)
First Posted : December 9, 2005
Last Update Posted : July 23, 2007
Information provided by:

December 8, 2005
December 9, 2005
July 23, 2007
November 2005
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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 Archive Site
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
Same as current
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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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Drug: UK-500,001
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2006
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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
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   Chile,   Croatia,   Czech Republic,   Hungary,   Singapore,   Spain,   United Kingdom
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Study Director: Pfizer Call Center Pfizer
July 2007

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