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

November 5, 2012 updated by: Pfizer

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults Diagnosed With Chronic Obstructive Pulmonary Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1425BEA
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1425DQU
        • Pfizer Investigational Site
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, C1904AGP
        • Pfizer Investigational Site
      • Vicente Lopez, Buenos Aires, Argentina, 1602
        • Pfizer Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Pfizer Investigational Site
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80060-900
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brazil, 90035-002
        • Pfizer Investigational Site
  • Chile
      • Santiago, Chile
        • Pfizer Investigational Site
      • ValparaÃ-so, Chile
        • Pfizer Investigational Site
    • Santiago
      • Providencia, Santiago, Chile
        • Pfizer Investigational Site
      • Recoleta, Santiago, Chile
        • Pfizer Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
  • Mexico
    • D.f.
      • México, D.f., Mexico, 14080
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Pfizer Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pfizer Investigational Site
    • California
      • Riverside, California, United States, 92506
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Pfizer Investigational Site
      • Clearwater, Florida, United States, 33765
        • Pfizer Investigational Site
    • Georgia
      • Riverdale, Georgia, United States, 30296
        • Pfizer Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • Pfizer Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52240
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Pfizer Investigational Site
    • Minnesota
      • Edina, Minnesota, United States, 55438
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55407
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, United States, 14215-1199
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45241
        • Pfizer Investigational Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Pfizer Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Pfizer Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Pfizer Investigational Site
      • Spartanburg, South Carolina, United States, 29307
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
    • Washington
      • Bellingham, Washington, United States, 98226
        • Pfizer Investigational Site
      • Renton, Washington, United States, 98055
        • Pfizer Investigational Site
      • Tukwila, Washington, United States, 98188
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in FEV1 compared to placebo

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2641022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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