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

Not Applicable

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: mometasone furoate nasal spray; Drug: placebo

• Registration Number: NCT00618332
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-20
• Study Start: 2008-04
• Primary Completion: 2008-07
• Study Completion: 2010-07
• Results First Submitted: 2013-11-21
• Results First Submitted QC: 2013-11-21
• Status Verified: 2014-01
• Results First Posted: 2014-01-10
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	mometasone furoate nasal spray	2 weeks of treatment
2	placebo	2 weeks of treatment

Primary Outcome Measures

Name	Time	Method
Global Assessment	at week 2	Global Assessment: 3=significantly improved, 2=moderately improved,; 1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States