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

This study has been completed.

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00219622

Purpose

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	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: tofimilast	Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tofimilast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in FEV1 compared to placebo

Secondary Outcome Measures:

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

Estimated Enrollment:	300
Study Start Date:	May 2004

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219622

Show 41 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A2641022
Study First Received:	September 11, 2005
Last Updated:	October 30, 2006
ClinicalTrials.gov Identifier:	NCT00219622
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009