Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

Study Overview
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Brief Summary
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A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.

Official Title
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Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female; minimum of 6 years of age and less than 12 years 2 year history of seasonal allergic rhinitis Exclusion Criteria: Concurrent disease that might interfere with the investigation or evaluation of te study medication Confirmed diagnosis of chronic rhinosinusitis within the last year Asthma, with the exception of mild intermittent asthma Anatomical nasal deformity Nasal obstruction Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR) Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids Ocular disorder other that allergic conjunctivitis

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 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: Olopatadine 0.6% 1 Spray<br>Olopatadine HCl 0.6% 1 spray per nostril twice daily | Drug: Olopatadine Hydrochloride Nasal Spray 0.6%<br>* Olopatadine HCl 1 or 2 sprays per nostril twice daily<br>|
| Placebo Comparator: Vehicle 1 spray<br>Vehicle 1 spray per nostril twice daily | Drug: Vehicle<br>* Vehicle 1 or 2 sprays per nostril twice daily<br>|
| Experimental: Olopatadine 0.6% 2 sprays<br>Olopatadine HCl 0.6% 2 sprays per nostril twice daily | Drug: Olopatadine Hydrochloride Nasal Spray 0.6%<br>* Olopatadine HCl 1 or 2 sprays per nostril twice daily<br>|
| Placebo Comparator: Vehicle 2 sprays<br>Vehicle 2 sprays per nostril twice daily | Drug: Vehicle<br>* Vehicle 1 or 2 sprays per nostril twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) | Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days. | Baseline through 2 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) | Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days. | Baseline through 2 weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic rhinitis, allergies, seasonal allergies