Clinical trial NCT00219622: A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Moderate-severe COPD (GOLD 2003 definition)
* Smoking history of at least 10 pack-years

Exclusion Criteria:

* Any significant co-morbid disease, particularly cardiovascular
* Use of any maintenance therapy except short acting bronchodilators

Primary outcomes:
measure: Change from baseline in FEV1 compared to placebo
Secondary outcomes:
measure: Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Riverside
country: United States
facility: Pfizer Investigational Site
state: California
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Riverdale
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Stockbridge
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Normal
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lake Oswego
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bellingham
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tukwila
country: United States
facility: Pfizer Investigational Site
state: Washington
city: La Plata
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Vicente Lopez
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: Recoleta
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: ValparaÃ-so
country: Chile
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: MÃ©xico
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo LeÃ³n
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: