Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes

Study Overview
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Brief Summary
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A real world evidence study that aims to understand the impact of RYALTRIS® nasal spray in patients with Allergic Rhinitis over a 28-day period.

Detailed Description
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The aim of this research is to develop a greater understanding of satisfaction with RYALTRIS® nasal spray in patients with Allergic Rhinitis (AR). There is currently no real-world evidence for patient satisfaction data with RYALTRIS® nasal spray. To address this knowledge gap and add to clinically relevant data to support Quality of Life (QoL) and patient reported outcomes, this research will evaluate the impact on quality of life (symptom control), using a Visual Analogue Scale (VAS), following initiation of RYALTRIS® to explore the relationship between baseline and subsequent QoL scores among patients initiated on RYALTRIS®.

Official Title
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Impact of RYALTRIS® (Olopatadine Hydrochloride / Mometasone Furoate Monohydrate) Nasal Spray on Patients' Reported Outcomes

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AR patients (moderate-to-severe SAR or PAR) with or without conjunctivitis who meet the following criteria will be offered the opportunity to participate in the study: Patients above 18 years old Fluent in English Patients newly prescribed RYALTRIS® who have not yet initiated treatment Willing and able to provide consent to participate Exclusion Criteria: Potential participants will be excluded if they: Are employed by a pharmaceutical company (to avoid conflict of interest) Are employed by a vaccine company (to avoid conflict of interest) Do not have access to the internet (to ensure validity of the data) Are unable to read and understand English (to ensure validity of the data) are currently or have previously been on RYALTRIS®

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with moderate to severe Allergic Rhinitis who have been prescribed RYALTRIS® nasal spray by their healthcare professional. Observational. | Other: Observational<br>* In this observational study, participants with moderate to severe Allergic Rhinitis who were initiated on Ryaltris® nasal spray by their healthcare professional will complete an online survey before commencement of treatment and then at days 1, 7, and 14 from treatment initiation. Survey completion at day 28 after treatment initiation will be optional for participants based on ongoing use of RYALTRIS®.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) | The primary study endpoint is the overall VAS score to determine improvement of Allergic Rhinitis symptoms and quality of life. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Allergic Rhinitis nasal symptoms | Response to a visual analogue scale about their Allergic Rhinitis nasal symptoms | 28 days | 
| Overall Allergic Rhinitis ocular symptoms | Response to a visual analogue scale about their Allergic Rhinitis ocular symptoms | 28 days | 
| Sleep quality | Response to a visual analogue scale about their sleep quality | 28 days | 
| Daily outdoor activities | Response to a visual analogue scale about their daily outdoor activities | 28 days | 
| Work productivity | Response to a visual analogue scale about their work productivity | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient outcomes, Patient satisfaction, Quality of Life