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CompletedNCT00150397Updated Jun 8, 2012

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

A Phase 2 interventional study of Tofimilast in Asthma, sponsored by Pfizer. Completed at 22 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-08.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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

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Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 112 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any significant co-morbid disease, particularly cardiovascular
  • Use of any maintenance therapy except short acting bronchodilators
  • Smoking history > or = 10 years
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
112 participants

Interventions

  • DrugTofimilast
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What researchers measure

Primary outcomes

  1. Change from baseline in FEV1 compared to placebo

Secondary outcomes

  1. Change from baseline in other lung function parameters, disease control and quality of life compared to placebo

07

Study locations

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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00150397
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 8, 2005
Start date
Mar 2005
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Jun 8, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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