Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes

NCT05129306 | Withdrawn DMC

• 1 other identifier: 20210902_1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Patient outcomes; Patient satisfaction; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Allergic Rhinitis nasal symptoms

  28 days

• Overall Allergic Rhinitis ocular symptoms

  28 days

• Sleep quality

  28 days

• Daily outdoor activities

  28 days

• Work productivity

  28 days

Study Arms (1)

Patients

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

Other: Observational

Interventions

Observational 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®.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• Community and Patient Preference Research Pty Ltd: lead
• Seqirus Limited: collaborator
• Glenmark Pharmaceuticals: collaborator

Study Sites (1)

Community and Patient Preference Research Pty Ltd

Sydney, New South Wales, 2000, Australia

Location

Related 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

  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.

  PMID: 19144261 BACKGROUND

• 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.

  PMID: 15692526 BACKGROUND

• 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.

  PMID: 32782442 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic; Patient Satisfaction

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Simon Fifer, PhD

  Community and Patient Preference Research Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: November 17, 2021
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)