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

Pfizer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

PF-03893787DRUG

Oral, two doses 12 hours apart

PlaceboDRUG

Oral, two doses 12 hours apart

MontelukastDRUG

Oral, two doses 12 hours apart

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Harrow, Middlesex, United Kingdom

Outcomes

Primary Outcomes

Spirometry pre- and post- bronchial allergen challenge

Time frame: 2 months

Secondary Outcomes

Laboratory safety tests

Time frame: 2 months

12-lead ECGs

Time frame: 2 months

Adverse Event reporting

Time frame: 2 months

Blood samples for pharmacokinetic measurement

Time frame: 2 months

Data from ClinicalTrials.gov

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