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

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

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 Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: mometasone furoate nasal spray; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 2 weeks of treatment	Drug: mometasone furoate nasal spray; 2 puffs in each nostril once a day for 2 weeks; Other Names: Nasonex
Placebo Comparator: 2; 2 weeks of treatment	Drug: placebo; 2 puffs in each nostril once a day for 2 weeks; 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

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Schering-Plough

Publications and helpful links

General Publications

• Sharma S, Vasnani R, De Tineo M, Du G, Pinto JM, Baroody FM, Naclerio RM. Recruitment factors which affect the outcome of a seasonal allergic rhinitis trial. Allergy Asthma Proc. 2011 Jan-Feb;32(1):55-63. doi: 10.2500/aap.2011.32.3414.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: February 6, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (Estimate): February 20, 2008

Study Record Updates

• Last Update Posted (Estimate): February 14, 2014
• Last Update Submitted That Met QC Criteria: January 21, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: 15624B