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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618332
• Other study ID #: 15624B
• Status: Completed
• Phase: N/A
• First received: February 6, 2008
• Last updated: January 21, 2014
• Start date: April 2008
• Est. completion date: July 2010

Study information

• Verified date: January 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• mometasone furoate nasal spray
2 puffs in each nostril once a day for 2 weeks
• placebo
2 puffs in each nostril once a day for 2 weeks

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Changes in RQLQ: Activity	The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life.	Baseline and 2 weeks	No
Secondary	Changes in RQLQ: Sleep	The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life.	Baseline and 2 weeks	No
Secondary	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	No
Secondary	Changes in RQLQ: Practical	The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life.	Baseline and 2 weeks	No
Secondary	Changes in RQLQ: Nasal	The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life.	Baseline and 2 weeks	No
Secondary	Changes in RQLQ: Emotional	The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life.	Baseline and 2 weeks	No
Secondary	Changes in RQLQ: Eye	The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life.	Baseline and 2 weeks	No