Clinical trial NCT00150397: A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline in FEV1 compared to placebo
Secondary outcomes:
measure: Change from baseline in other lung function parameters, disease control and quality of life compared to placebo
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Pfizer Investigational Site
state: California
city: Riverside
country: United States
facility: Pfizer Investigational Site
state: California
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Normal
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Skillman
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Barrio Aranjuez
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Vellore
country: India
facility: Pfizer Investigational Site
state: Tamilnadu
city: Noida
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: