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

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ClinicalTrials.gov Identifier: NCT00150397
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : June 8, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Tofimilast Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : March 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
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, disease control and quality of life compared to placebo


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00150397


  Show 22 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00150397     History of Changes
Other Study ID Numbers: A2641021
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases