A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics

June 7, 2012 updated by: Pfizer

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six-Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults With Persistent Asthma

This is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

112

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

  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
    • San Jose
      • Barrio Aranjuez, San Jose, Costa Rica
        • Pfizer Investigational Site
  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 014
        • Pfizer Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 034
        • Pfizer Investigational Site
    • Tamilnadu
      • Vellore, Tamilnadu, India, 632002
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Noida, Uttar Pradesh, India, 201301
        • Pfizer Investigational Site
  • United States
    • California
      • Encinitas, California, United States, 92024
        • Pfizer Investigational Site
      • Riverside, California, United States, 92506
        • Pfizer Investigational Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30281
        • Pfizer Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Pfizer Investigational Site
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45241
        • Pfizer Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild to moderate persistent asthma (NAEPP/GINA Step 2-3)
  • Reversibility to albuterol at least 12% and 200 mL

Exclusion Criteria:

  • Any significant co-morbid disease, particularly cardiovascular
  • Use of any maintenance therapy except short acting bronchodilators
  • Smoking history > or = 10 years

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, disease control and 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

March 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

June 8, 2012

Last Update Submitted That Met QC Criteria

June 7, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2641021

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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