A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease
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
1 other identifier
interventional
300
6 countries
40
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2004
Shorter than P25 for phase_2
40 active sites
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
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 11, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedNovember 7, 2012
November 1, 2012
1.2 years
September 11, 2005
November 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in FEV1 compared to placebo
Secondary Outcomes (1)
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
Interventions
Eligibility Criteria
You may qualify if:
- Moderate-severe COPD (GOLD 2003 definition)
- Smoking history of at least 10 pack-years
You may not qualify if:
- Any significant co-morbid disease, particularly cardiovascular
- Use of any maintenance therapy except short acting bronchodilators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (40)
Pfizer Investigational Site
Phoenix, Arizona, 85006, United States
Pfizer Investigational Site
Riverside, California, 92506, United States
Pfizer Investigational Site
Clearwater, Florida, 33756, United States
Pfizer Investigational Site
Clearwater, Florida, 33765, United States
Pfizer Investigational Site
Riverdale, Georgia, 30296, United States
Pfizer Investigational Site
Stockbridge, Georgia, 30281, United States
Pfizer Investigational Site
Normal, Illinois, 61761, United States
Pfizer Investigational Site
Iowa City, Iowa, 52240, United States
Pfizer Investigational Site
Madisonville, Kentucky, 42431, United States
Pfizer Investigational Site
Wheaton, Maryland, 20902, United States
Pfizer Investigational Site
Edina, Minnesota, 55438, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55407, United States
Pfizer Investigational Site
Buffalo, New York, 14215-1199, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28207, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45241, United States
Pfizer Investigational Site
Lake Oswego, Oregon, 97035, United States
Pfizer Investigational Site
Lincoln, Rhode Island, 02865, United States
Pfizer Investigational Site
Spartanburg, South Carolina, 29303, United States
Pfizer Investigational Site
Spartanburg, South Carolina, 29307, United States
Pfizer Investigational Site
Dallas, Texas, 75231, United States
Pfizer Investigational Site
Bellingham, Washington, 98226, United States
Pfizer Investigational Site
Renton, Washington, 98055, United States
Pfizer Investigational Site
Tukwila, Washington, 98188, United States
Pfizer Investigational Site
La Plata, Buenos Aires, C1904AGP, Argentina
Pfizer Investigational Site
Vicente López, Buenos Aires, 1602, Argentina
Pfizer Investigational Site
Rosario, Santa Fe Province, 2000, Argentina
Pfizer Investigational Site
Buenos Aires, 1426, Argentina
Pfizer Investigational Site
Buenos Aires, C1425BEA, Argentina
Pfizer Investigational Site
Buenos Aires, C1425DQU, Argentina
Pfizer Investigational Site
Curitiba, Paraná, 80060-900, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-002, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Pfizer Investigational Site
Providencia, Santiago Metropolitan, Chile
Pfizer Investigational Site
Recoleta, Santiago Metropolitan, Chile
Pfizer Investigational Site
Santiago, Chile
Pfizer Investigational Site
ValparaÃ-so, Chile
Pfizer Investigational Site
San José, Provincia de San José, Costa Rica
Pfizer Investigational Site
México, D.f., 14080, Mexico
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
Pfizer Investigational Site
Monterrey, Nuevo León, 64460, Mexico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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 11, 2005
First Posted
September 22, 2005
Study Start
May 1, 2004
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
November 7, 2012
Record last verified: 2012-11