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

Phase 2

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00263874
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-08
• Study First Submitted QC: 2005-12-08
• Study First Posted: 2005-12-09
• Study Completion: 2006-09
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-20
• Last Update Posted: 2007-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo

Secondary Outcome Measures

Name	Time	Method
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Manchester, United Kingdom