Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis?

University of Chicago40 enrolled

Overview

We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Seasonal Allergic Rhinitis

Interventions

mometasone furoate nasal sprayDRUG

2 puffs in each nostril once a day for 2 weeks

placeboDRUG

2 puffs in each nostril once a day for 2 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Males and females between 18 and 60 years of age. 2. History of grass and/or ragweed allergic rhinitis. 3. Positive skin or RAST test to grass, trees and/or ragweed antigen. 4. Symptomatic at time of entry into study. Exclusion Criteria 1. Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are pregnant or breastfeeding. 2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease). 3. Use of any other investigational agent in the last 30 days. 4. Absence of nasal symptoms. 5. Smoking. 6. URI at the time of screening.

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Global Assessment

Global Assessment: 3=significantly improved, 2=moderately improved, 1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse

Time frame: at week 2

Secondary Outcomes

Changes in RQLQ: Overall

The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores.