PF-04191834 Single Dose Bronchodilatory Study In Asthma.
- Registration Number
- NCT00723021
- Lead Sponsor
- Pfizer
- Brief Summary
Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Persistent mild/moderate asthma for at least 6 months.
- Reduced lung function
- Reversible airway obstruction
Exclusion Criteria
- Pregnant/nursing females.
- Liver function tests greater than upper limit of normal (ULN)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PF-04191834 2000mg PF-04191834 - zileuton zileuton - placebo Placebo - PF-04191834 30mg PF-04191834 - PF-04191834 100mg PF-04191834 -
- Primary Outcome Measures
Name Time Method Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Baseline, 24 hours (hrs) post-dose The FEV1 is the maximal volume of air that can be forcefully exhaled in one second
- Secondary Outcome Measures
Name Time Method Change From Baseline in Forced Vital Capacity (FVC) Baseline,24 hours (hrs) post-dose The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible
Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) Baseline, 24 hours (hrs) post-dose The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Omaha, Nebraska, United States