PF-04191834 Single Dose Bronchodilatory Study In Asthma.

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: PF-04191834; Drug: zileuton; Drug: Placebo

• 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

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-28
• Primary Completion: 2008-12
• Study Completion: 2009-07
• Disposition First Submitted: 2011-03-16
• Disposition First Submitted QC: 2011-03-16
• Disposition First Posted: 2011-03-28
• Status Verified: 2012-12
• Results First Submitted: 2012-12-27
• Results First Submitted QC: 2012-12-27
• Last Update Submitted: 2012-12-27
• Results First Posted: 2013-02-01
• Last Update Posted: 2013-02-01

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