Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes

Withdrawn

• Conditions: Allergic Rhinitis

• Registration Number: NCT05129306
• Lead Sponsor: Community and Patient Preference Research Pty Ltd

Brief Summary

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

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®.

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study Start: 2021-11-17
• Study First Posted: 2021-11-22
• Status Verified: 2022-03
• Primary Completion: 2022-03-14
• Study Completion: 2022-03-14
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)	28 days	The primary study endpoint is the overall VAS score to determine improvement of Allergic Rhinitis symptoms and quality of life.

Secondary Outcome Measures

Name	Time	Method
Overall Allergic Rhinitis nasal symptoms	28 days	Response to a visual analogue scale about their Allergic Rhinitis nasal symptoms
Overall Allergic Rhinitis ocular symptoms	28 days	Response to a visual analogue scale about their Allergic Rhinitis ocular symptoms
Sleep quality	28 days	Response to a visual analogue scale about their sleep quality
Daily outdoor activities	28 days	Response to a visual analogue scale about their daily outdoor activities
Work productivity	28 days	Response to a visual analogue scale about their work productivity

Trial Locations

Locations (1)

Community and Patient Preference Research Pty Ltd; 🇦🇺 Sydney, New South Wales, Australia