Clinical trial NCT05129306: Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes
Official title: Impact of RYALTRIS® (Olopatadine Hydrochloride / Mometasone Furoate Monohydrate) Nasal Spray on Patients' Reported Outcomes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Allergic Rhinitis
Keywords: Patient outcomes
Patient satisfaction
Quality of Life
Lead sponsor: Community and Patient Preference Research Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Seqirus Limited
name: Glenmark Pharmaceuticals
First posted: 2021-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The primary population will be patients with moderate to severe Seasonal Allergic Rhinitis (SAR) or Perennial Allergic Rhinitis (PAR) in Australia who have been newly prescribed RYALTRIS® for management of their disease.

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®.

Eligibility criteria: 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®

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 28 days
Secondary outcomes:
measure: Overall Allergic Rhinitis nasal symptoms
timeFrame: 28 days
measure: Overall Allergic Rhinitis ocular symptoms
timeFrame: 28 days
measure: Sleep quality
timeFrame: 28 days
measure: Daily outdoor activities
timeFrame: 28 days
measure: Work productivity
timeFrame: 28 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Community and Patient Preference Research Pty Ltd
state: New South Wales
Study officials:
affiliation: Community and Patient Preference Research Pty Ltd
name: Simon Fifer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
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. doi: 10.1016/j.otohns.2004.10.010.
citation: 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.