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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Does the Response to a Nasal Decongestant Test Predict the Outcome to Treatment of Seasonal Allergic Rhinitis With Nasonex?

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: mometasone furoate nasal spray
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Males and females between 18 and 60 years of age. History of grass and/or ragweed allergic rhinitis. Positive skin or RAST test to grass, trees and/or ragweed antigen. Symptomatic at time of entry into study. Exclusion Criteria 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. 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). Use of any other investigational agent in the last 30 days. Absence of nasal symptoms. Smoking. URI at the time of screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>2 weeks of treatment | Drug: mometasone furoate nasal spray<br>* 2 puffs in each nostril once a day for 2 weeks<br>* Other names: Nasonex;|
| Placebo Comparator: 2<br>2 weeks of treatment | Drug: placebo<br>* 2 puffs in each nostril once a day for 2 weeks<br>* Other names: placebo comparator for Nasonex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 2 weeks | 
| Changes in RQLQ: Activity | The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks | 
| Changes in RQLQ: Sleep | The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks | 
| Changes in RQLQ: Non-Nasal/Eye | The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks | 
| Changes in RQLQ: Practical | The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks | 
| Changes in RQLQ: Nasal | The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks | 
| Changes in RQLQ: Emotional | The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks | 
| Changes in RQLQ: Eye | The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life. | Baseline and 2 weeks |