A Study To Assess The Effect Of PF-03526299 On Lung Function Following An Allergen Challenge In Asthmatic Subjects

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: PF-03526299; Drug: Placebo; Drug: Fluticasone propionate

• Registration Number: NCT00877539
• Lead Sponsor: Pfizer

Brief Summary

PF-03526299, 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: 2009-04-06
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Study Start: 2009-06
• Primary Completion: 2009-12
• Study Completion: 2010-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-27
• Last Update Posted: 2010-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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-03526299	PF-03526299	-
Placebo	Placebo	-
Fluticasone propionate	Fluticasone propionate	-

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
Sputum for pharmacodynamic measurement	2 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Manchester, United Kingdom