N/A
N=40
Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis?
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00618332 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Global Assessment — 1.7; 1.4 units on a scale — p=0.372
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mometasone furoate nasal spray (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Assessment |
1.7; 1.4 | 0.372 |
| SECONDARY Changes in RQLQ: Overall |
-1.35; -1.25 | 0.775 |
| SECONDARY Changes in RQLQ: Activity |
-1.73; -1.55 | 0.737 |
| SECONDARY Changes in RQLQ: Sleep |
-1.42; -0.85 | 0.117 |
| SECONDARY Changes in RQLQ: Non-Nasal/Eye |
-1.11; -1.26 | 0.676 |
| SECONDARY Changes in RQLQ: Practical |
-1.37; -1.48 | 0.795 |
| SECONDARY Changes in RQLQ: Nasal |
-1.54; -1.31 | 0.638 |
| SECONDARY Changes in RQLQ: Emotional |
-1.05; -0.94 | 0.800 |
| SECONDARY Changes in RQLQ: Eye |
-1.36; -1.34 | 0.968 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00618332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.