A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00219622
• Lead Sponsor: Pfizer

Brief Summary

This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Moderate-severe COPD (GOLD 2003 definition)
• Smoking history of at least 10 pack-years

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Exclusion Criteria

• Any significant co-morbid disease, particularly cardiovascular
• Use of any maintenance therapy except short acting bronchodilators

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in 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; 🇲🇽 Monterrey, Nuevo León, Mexico