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Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05129306
Enrollment
0
Registered
2021-11-22
Start date
2021-11-17
Completion date
2022-03-14
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Patient outcomes, Patient satisfaction, Quality of Life

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®.

Interventions

OTHERObservational

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®.

Sponsors

Seqirus Limited
CollaboratorUNKNOWN
Glenmark Pharmaceuticals
CollaboratorUNKNOWN
Community and Patient Preference Research Pty Ltd
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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®

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scale (VAS)28 daysThe primary study endpoint is the overall VAS score to determine improvement of Allergic Rhinitis symptoms and quality of life.

Secondary

MeasureTime frameDescription
Overall Allergic Rhinitis nasal symptoms28 daysResponse to a visual analogue scale about their Allergic Rhinitis nasal symptoms
Overall Allergic Rhinitis ocular symptoms28 daysResponse to a visual analogue scale about their Allergic Rhinitis ocular symptoms
Sleep quality28 daysResponse to a visual analogue scale about their sleep quality
Daily outdoor activities28 daysResponse to a visual analogue scale about their daily outdoor activities
Work productivity28 daysResponse to a visual analogue scale about their work productivity

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026