A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: PF-03893787; Drug: Placebo; Drug: Montelukast

• Registration Number: NCT00856687
• Lead Sponsor: Pfizer

Brief Summary

PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Study Start: 2009-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-21
• Last Update Posted: 2010-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Males and females 18-60 years.
• Mild asthma
• Atopic to allergens

Exclusion Criteria

• Unstable asthma.
• Smokers or recent ex-smokers
• Recent allergen challenge

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-03893787	PF-03893787	-
Placebo	Placebo	-
Montelukast	Montelukast	-

Primary Outcome Measures

Name	Time	Method
Spirometry pre- and post- bronchial allergen challenge	2 months

Secondary Outcome Measures

Name	Time	Method
Laboratory safety tests	2 months
12-lead ECGs	2 months
Adverse Event reporting	2 months
Blood samples for pharmacokinetic measurement	2 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Harrow, Middlesex, United Kingdom