Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial

Study Overview
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Brief Summary
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Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

Official Title
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A Double-masked, Randomized, Parallel Group, Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Olopatadine HCL Nasal Spray, 0.6%
* Drug: Fluticasone Propionate Nasal Spray, 50 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion: A history of spring/summer seasonal allergies. Positive skin prick test for the currently prevalent allergen of the area. Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article. For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study. Exclusion: History of chronic sinusitis. Asthma, with the exception of intermittent asthma. Smokers. Known non-responders to antihistamines. Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids. Chronic use of long acting antihistamines. Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1. Relatives of study site staff or other individuals who had access to the clinical study protocol. Participation in any other investigational study within 30 days before entry into this study or concomitantly with 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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Accepts Healthy Volunteers

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>Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily | Drug: Olopatadine HCL Nasal Spray, 0.6%<br>* Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily<br>|
| Active Comparator: Fluticasone Propionate Nasal Spray, 50 mcg<br>Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily | Drug: Fluticasone Propionate Nasal Spray, 50 mcg<br>* Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent 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 Percent Change in Instantaneous Total Nasal Symptom Score (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 Percent 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 Percent 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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Rhinitis, Seasonal Allergic Rhinitis, allergies