A Study To Explore The Effect On Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.

Pfizer18 enrolled

Overview

After a nasal allergen challenge it should be possible to measure markers of inflammation that may be useful to assess the properties of future drugs. If these markers are reproducible and impacted by the study drugs they could be useful for future drug development.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

IbuprofenDRUG

800 mg oral

Fluticasone propionateDRUG

200 mcg intra-nasal

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects with seasonal allergic rhinitis (out of season). * Sensitive to ragweed skin prick test and screening nasal allergen challenge. Exclusion Criteria: * Subjects with significant concomitant diseases. * Subjects with symptoms of allergic rhinitis in 2 weeks prior to screening. * Female subjects that are pregnant or nursing. Subjects with hypersensitivity to study drugs or allergen challenge.

Locations (1)

Pfizer Investigational Site

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Nasal inflammatory markers

Time frame: 8h 45 min post dose

Acoustic rhinometry

Time frame: 8h 45 min post dose

Nasal symptom scores

Time frame: 8h 45 min post dose

Secondary Outcomes

Spirometry

Time frame: 8h 45 min post dose

Data from ClinicalTrials.gov

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