Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05129306
• Other study ID #: 20210902_1
• Status: Withdrawn
• Start date: November 17, 2021
• Est. completion date: March 14, 2022

Study information

• Verified date: March 2022
• Source: Community and Patient Preference Research Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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®.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 14, 2022
• Est. primary completion date: March 14, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• 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®.

Locations

Country	Name	City	State
Australia	Community and Patient Preference Research Pty Ltd	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
Community and Patient Preference Research Pty Ltd	Glenmark Pharmaceuticals, Seqirus Limited

Country where clinical trial is conducted

Australia, 

References & Publications (4)

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

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. — View Citation

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. — View Citation

Price D, Klimek L, Gálffy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Allergic Rhinitis nasal symptoms	Response to a visual analogue scale about their Allergic Rhinitis nasal symptoms	28 days
Secondary	Overall Allergic Rhinitis ocular symptoms	Response to a visual analogue scale about their Allergic Rhinitis ocular symptoms	28 days
Secondary	Sleep quality	Response to a visual analogue scale about their sleep quality	28 days
Secondary	Daily outdoor activities	Response to a visual analogue scale about their daily outdoor activities	28 days
Secondary	Work productivity	Response to a visual analogue scale about their work productivity	28 days