Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis

Study Overview
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Brief Summary
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To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Olopatadine 0.6% / Azelastine 137 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment 18 yrs of age or older Read and sign informed consent Females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control. Exclusion Criteria: History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride. Any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): Rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection. Impairment of sense of tast or smell (self reported) Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines) Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption Patients w/a severe impairment of nasal breathing Anatomic abnormalities of as identified by nasal examination History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study. History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olopatadine 0.6% / Azelastine 137 mcg | Drug: Olopatadine 0.6% / Azelastine 137 mcg<br>* single dose; 2 sprays per nostril<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Preference Questionnaire for Immediate Taste | Using a set of coded responses, subjects evaluated product preference in regards to immediate taste | 5 min post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste and Aftertaste of Medication |  | 5 min, 45 min. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhinitis