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

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ClinicalTrials.gov Identifier: NCT00219622
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: tofimilast Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources




Primary Outcome Measures :
  1. Change from baseline in FEV1 compared to placebo

Secondary Outcome Measures :
  1. Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219622


  Show 40 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00219622     History of Changes
Other Study ID Numbers: A2641022
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes