Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Olopatadine HCl Nasal Spray, 0.6%
* Drug: Azelastine HCl Nasal Spray, 0.1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide consent/assent History of spring/summer allergic rhinitis Positive skin prick and/or intradermal test Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations Non-pregnant (where applicable) Able to complete daily diary Exclusion Criteria: Smoker Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps History of current chronic sinusitis Asthma Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses History or evidence of nasolacrimal drainage system malfunction

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olopatadine HCl Nasal Spray, 0.6%<br> | Drug: Olopatadine HCl Nasal Spray, 0.6%<br>* 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days<br>|
| Active Comparator: Azelastine HCl Nasal Spray, 0.1%<br> | Drug: Azelastine HCl Nasal Spray, 0.1%<br>* 2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline | Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication. | 14 days minus baseline | 
| Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline | Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication. | 14 days minus baseline | 
| Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline | Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing. | 14 days minus baseline | 
| Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline | Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing. | 14 days minus baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergy, Rhinitis, Nasal Spray, Antihistamine, Intranasal Corticosteroid