A Phase 2 Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics

This study has been completed.

First Received: September 6, 2005 Last Updated: October 30, 2006 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150397

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Tofimilast	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Tofimilast

U.S. FDA Resources

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, disease control and quality of life compared to placebo

Estimated Enrollment:	112
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150397

Show 22 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	A2641021
Study First Received:	September 6, 2005
Last Updated:	October 30, 2006
ClinicalTrials.gov Identifier:	NCT00150397 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on August 30, 2009