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

Phase 2 Terminated 324 enrolled Pfizer

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2005-11
Primary completion: —
Completion: 2006-09

Outcome

Missed primary endpoint

Stopped: “The decision to terminate was completely related to efficacy and there were no safety concerns.”

paper No effect on the primary efficacy parameter, other measures of lung function or symptom scores PMID 19213793 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	UK-500,001	Small molecule	0.1 mg	Inhaled
Subject	UK-500,001	Small molecule	0.4 mg	Inhaled
Subject	UK-500,001	Small molecule	1 mg	Inhaled