Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes

NCT ID: NCT05129306

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-17

Study Completion Date

2022-03-14

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®.

Conditions

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Allergic Rhinitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with moderate to severe Allergic Rhinitis who have been prescribed RYALTRIS® nasal spray by their healthcare professional. Observational.

Observational

Intervention Type OTHER

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®.

Interventions

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Observational

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®.

Intervention Type OTHER

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®
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seqirus Limited

UNKNOWN

Sponsor Role collaborator

Glenmark Pharmaceuticals

UNKNOWN

Sponsor Role collaborator

Community and Patient Preference Research Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Fifer, PhD

Role: PRINCIPAL_INVESTIGATOR

Community and Patient Preference Research Pty Ltd

Locations

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Community and Patient Preference Research Pty Ltd

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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Australian Institute of Health and Welfare 2019. Allergic rhinitis ('hay fever'). Cat. no. PHE 257. Canberra: AIHW. Viewed 01 May 2020, https://www.aihw.gov.au/reports/chronic-respiratory-conditions/allergic-rhinitis-hay-fever/contents/allergic-rhinitis

Reference Type BACKGROUND

Meltzer EO, Garadi R, Laforce C, Chadwick SJ, Berger WE, Gross G, Edwards MR, Crenshaw K, Wall GM. Comparative study of sensory attributes of two antihistamine nasal sprays: olopatadine 0.6% and azelastine 0.1%. Allergy Asthma Proc. 2008 Nov-Dec;29(6):659-68. doi: 10.2500/aap.2008.29.3181. Epub 2008 Dec 6.

Reference Type BACKGROUND
PMID: 19144261 (View on PubMed)

Meltzer EO, Hadley J, Blaiss M, Benninger M, Kimel M, Kleinman L, Dupclay L, Garcia J, Leahy M, Georges G. Development of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis. Otolaryngol Head Neck Surg. 2005 Feb;132(2):197-207. doi: 10.1016/j.otohns.2004.10.010.

Reference Type BACKGROUND
PMID: 15692526 (View on PubMed)

Price D, Klimek L, Galffy G, Emmeluth M, Koltun A, Kopietz F, Nguyen DT, van Weissenbruch R, Pohl W, Kuhl HC, Scadding G, Mullol J. Allergic rhinitis and asthma symptoms in a real-life study of MP-AzeFlu to treat multimorbid allergic rhinitis and asthma. Clin Mol Allergy. 2020 Aug 6;18:15. doi: 10.1186/s12948-020-00130-9. eCollection 2020.

Reference Type BACKGROUND
PMID: 32782442 (View on PubMed)

Other Identifiers

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20210902_1

Identifier Type: -

Identifier Source: org_study_id

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