Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529)

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

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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Mometasone furoate nasal spray (MFNS)
* Drug: Matching placebo nasal spray


Participation Criteria
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Eligibility Criteria
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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 1. 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Mometasone furoate nasal spray 200 mcg QD (once per day) | Drug: Mometasone furoate nasal spray (MFNS)<br>* MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days<br>* Other names: Nasonex Nasal Spray;|
| Placebo Comparator: Arm 2<br>Matching placebo nasal spray | Drug: Matching placebo nasal spray<br>* Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days | Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours [reflective]) | 15 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days | Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]) | 15 days of treatment |