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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

2 weeks of treatment

Group Type ACTIVE_COMPARATOR

mometasone furoate nasal spray

Intervention Type DRUG

2 puffs in each nostril once a day for 2 weeks

2

2 weeks of treatment

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

2 puffs in each nostril once a day for 2 weeks

Interventions

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mometasone furoate nasal spray

2 puffs in each nostril once a day for 2 weeks

Intervention Type DRUG

placebo

2 puffs in each nostril once a day for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Nasonex placebo comparator for Nasonex

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No