NCT00150397

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2 asthma

Geographic Reach
3 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

8 months

First QC Date

September 6, 2005

Last Update Submit

June 7, 2012

Conditions

Asthma

Outcome Measures

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

Interventions

TofimilastDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pfizer Investigational Site

Encinitas, California, 92024, United States

Location

Pfizer Investigational Site

Riverside, California, 92506, United States

Location

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30281, United States

Location

Pfizer Investigational Site

Normal, Illinois, 61761, United States

Location

Pfizer Investigational Site

Madisonville, Kentucky, 42431, United States

Location

Pfizer Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01107, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55402, United States

Location

Pfizer Investigational Site

Skillman, New Jersey, 08558, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45241, United States

Location

Pfizer Investigational Site

Lincoln, Rhode Island, 02865, United States

Location

Pfizer Investigational Site

Kingsport, Tennessee, 37660, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Pfizer Investigational Site

Barrio Aranjuez, Provincia de San José, Costa Rica

Location

Pfizer Investigational Site

San José, Provincia de San José, Costa Rica

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400 014, India

Location

Pfizer Investigational Site

Chennai, Tamil Nadu, 600 034, India

Location

Pfizer Investigational Site

Vellore, Tamil Nadu, 632002, India

Location

Pfizer Investigational Site

Noida, Uttar Pradesh, 201301, India

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

tofimilast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

March 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

IN(4)CO(2)US(16)