Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

Phase 4CompletedNCT00791973

University of Chicago15 enrolled

Overview

The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

fluticasone furoateDRUG

2 puffs in each nostril once daily for 1 week

PlaceboDRUG

2 puffs in each nostril once daily for 1 week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females between 18 and 45 years of age. 2. History of grass and/or ragweed allergic rhinitis. 3. Positive skin test to grass and/or ragweed antigen. 4. Positive response to screening nasal challenge. Exclusion Criteria: 1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. Pregnant or lactating women. 3. Upper respiratory infection within 14 days of study start.

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Change in Tryptase Level From Baseline to Post-antigen Challenge

Tryptase levels (mcg/L) were measured from nasal lavages

Time frame: After one week of treatment wtih veramyst or placebo

Secondary Outcomes

Total Eye Symptom Scores After Antigen Challenge

Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe

Time frame: After one week of treatment wtih veramyst or placebo

Data from ClinicalTrials.gov

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