Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis

Study Overview
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Brief Summary
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The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).

Conditions
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Vasomotor Rhinitis

Intervention / Treatment
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* Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6%
* Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis Negative skin tests to a panel of allergens and positive histamine test within last 2 years History of symptoms related to defined VMR triggers Exclusion Criteria: Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit Chronic use of drugs that can cause rhinitis

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: 1<br>Olopatadine HCL Nasal Spray, 0.6% | Drug: Olopatadine HCL (Patanase) Nasal Spray, 0.6%<br>* 2 sprays/ nostril BID<br>|
| Active Comparator: 2<br>Azelastine HCl Nasal Spray, 137 mcg | Drug: Azelastine HCl (Astelin) Nasal Spray, 137 mcg<br>* 2 sprays/ nostril BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in 2-week rTNSS From Baseline | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Rhinorrhea Reflective Score | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. | 2 week | 
| Mean Change Postnasal Drip Reflective Score | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. | 2 Weeks | 
| Mean Change Nasal Congestion Reflective Score | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. | 2 Weeks | 
| Mean Change in Sneezing Reflective Score | Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip 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 totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication. | 2 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VMR, vasomotor rhinitis, chronic non-allergic rhinitis