Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)

Organon and Co0 sites333 target enrollmentAugust 2008

ConditionsAllergic Rhinitis

InterventionsMometasone furoate nasal spray (MFNS)Matching placebo nasal spray

DrugsMometasone furoate nasal spray (MFNS)Matching placebo nasal spray

Overview

Phase: Phase 3
Intervention: Mometasone furoate nasal spray (MFNS)
Conditions: Allergic Rhinitis
Sponsor: Organon and Co
Enrollment: 333
Primary Endpoint: Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

October 2008

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A subject must be 12 years of age or older, of either sex, and of any race.
•A subject must have at least a 2-year history of SAR which exacerbates during the study season.
•A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit
•A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria

•A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
•A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
•A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
•A subject who is participating in any other clinical study.
•A subject who is part of the staff personnel directly involved with this study.
•A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
•A female subject who is breast-feeding, pregnant, or intends to become pregnant.
•A subject previously randomized into this study.
•A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.

Arms & Interventions

Arm 1

Mometasone furoate nasal spray 200 mcg QD (once per day)

Intervention: Mometasone furoate nasal spray (MFNS)

Arm 2

Matching placebo nasal spray

Intervention: Matching placebo nasal spray

Outcomes

Primary Outcomes

Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days

Time Frame: 15 days of treatment

Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\]). Baseline is the average score from the 3 days prior to the first dose of study drug.