Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion. The secondary objectives of this study are to evaluate the potential of the combination to produce tachyphylaxis and/or rebound congestion, and to evaluate the safety of the combination.

Official Title
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Efficacy and Safety of Concurrent Administration of Mometasone Furoate Nasal Spray (MFNS) and Oxymetazoline Nasal Spray Administered Once Daily (QD) vs. Oxymetazoline Twice Daily (BID), Mometasone Furoate QD, and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)
* Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)
* Drug: mometasone furoate nasal spray (MFNS) once daily
* Drug: oxymetazoline nasal spray (OXY) twice daily
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 12 years of age or older, of either sex, and of any race. Must have at least a 2-year documented history of SAR which exacerbates during the time period over which the subject will be participating. Must have a documented (within the past 12 months) positive skin-prick test response to an appropriate seasonal allergen appropriate to the geographical vicinity in which the study is being carried out and over the period of time the subject is participating. Must be clinically symptomatic at the Screening and Baseline Visits. Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram results. Must be free of any clinically significant disease, other than SAR, which would interfere with the study evaluations. Must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and study requirements. Female subjects of child-bearing potential must have a negative serum pregnancy test at screening. Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control prior to screening and during the entire study. Must have the ability to transmit electronic diary data on a regular basis. Exclusion Criteria: A subject with a history of anaphylaxis and/or other severe local reaction(s) to skin testing. A subject with asthma who requires chronic use of inhaled or systemic corticosteroids. A subject with current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. A subject with rhinitis medicamentosa. A subject with glaucoma and/or increased intraocular pressure. A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow. A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids. A pregnant or nursing female. A subject with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, pulmonary, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diaries.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination1<br>Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily | Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)<br>* MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).<br>* Other names: MFNS + OXY combination;|
| Experimental: Combination3<br>MFNS with OXY 3 sprays once daily | Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)<br>* MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.<br>* Other names: MFNS + OXY combination assessing a different dose (ie, number of sprays) from that used in Group 1;|
| Active Comparator: Mometasone<br>MFNS once daily | Drug: mometasone furoate nasal spray (MFNS) once daily<br>* MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening.<br>* Other names: MFNS QD;|
| Active Comparator: Oxymetazoline<br>OXY twice daily | Drug: oxymetazoline nasal spray (OXY) twice daily<br>* OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.<br>* Other names: OXY BID;|
| Placebo Comparator: Placebo<br>Placebo nasal spray | Drug: Placebo<br>* Matching placebo to MFNS given every morning and every evening x 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15 | Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period. | 15 days of treatment | 
| Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score | Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1. | from baseline to hour 4 on Day 1 |