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

Phase 2TerminatedNCT00263874

Pfizer324 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

324

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

UK-500,001DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (28)

Pfizer Investigational Site

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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