Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray

NCT05146206 | Completed Results DMC

• 1 other identifier: 20210902_2
• Study Type: observational
• Target: 426
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®).

Conditions

Allergic Rhinitis

Keywords

Patient preference; Best-Worst Scaling; Treatment attributes

Outcome Measures

Primary Outcomes (1)

• Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score)

  The primary study endpoint is the overall index score from the Best Worst Scaling exercise, to reflect satisfaction and importance of treatment attributes of the RYALTRIS® and DYMISTA® nasal spray. Index scores from the Best Worst Scaling exercise range from 0 to 100, with higher scores indicating higher satisfaction of treatment attributes.

  Cross-sectional - through study completion, an average of 3 months

Secondary Outcomes (1)

• Rescaled Scores From Best-Worst Scaling Task

  Cross-sectional - through study completion, an average of 3 months

Study Arms (2)

Patients on RYALTRIS

Patients who are currently using RYALTRIS nasal spray.

Other: Observational

Patients on DYMISTA

Patients who are currently using DYMISTA nasal spray.

Other: Observational

Interventions

Observational OTHER

In this observational study, participants initated on RYALTRIS/DYMISTA nasal spray will complete a cross-sectional online survey that includes a Best-Worst Scaling task to capture their satisfaction and importance of various treatment attributes.

Patients on DYMISTA; Patients on RYALTRIS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 SAR or PAR with or without conjunctivitis in Australia who have been initiated on RYALTRIS® or DYMISTA® in that last 12 months. The expected sample size is between 200 to 400 patients. 100-200 patients initiated on RYALTRIS® and 100-200 patients initiated on DYMISTA® nasal spray in the last 12 months.

You may qualify if:

• Allergic Rhinitis patients (moderate-to-severe Seasonal Allergic Rhinitis or Perennial Allergic Rhinitis) 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 initiated on RYALTRIS® or DYMISTA® nasal spray in the last 12 months and currently using treatment
• Willing and able to provide consent to participate

You may not qualify if:

• Have reported a loss of taste and/or smell related to COVID-19 (or other medical condition)
• 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)

Sponsors & Collaborators

• Community and Patient Preference Research Pty Ltd: lead
• Seqirus: collaborator
• Glenmark Pharmaceuticals S.A.: collaborator

Study Sites (1)

Community and Patient Preference Research Pty Ltd

Sydney, New South Wales, 2000, Australia

Location

Related Publications (7)

• 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, Bardelas J, Goldsobel A, Kaiser H. A preference evaluation study comparing the sensory attributes of mometasone furoate and fluticasone propionate nasal sprays by patients with allergic rhinitis. Treat Respir Med. 2005;4(4):289-96. doi: 10.2165/00151829-200504040-00007.

  PMID: 16086602 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

• Louviere, J., Flynn, T., Marley, A., 2015. References. In Best-Worst Scaling: Theory, Methods and Applications Cambridge University, Cambridge, pp. 316-331

  BACKGROUND

• Muhlbacher AC, Kaczynski A, Zweifel P, Johnson FR. Experimental measurement of preferences in health and healthcare using best-worst scaling: an overview. Health Econ Rev. 2016 Dec;6(1):2. doi: 10.1186/s13561-015-0079-x. Epub 2016 Jan 8.

  PMID: 26743636 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic; Patient Preference

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Satisfaction; 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

Results Point of Contact

• Title: Dr Lili Toh
• Organization: Community and Patient Preference Research (CaPPRe)

lili.toh@cappre.com.au

+61 452551409

Study Officials

• Simon Fifer, PhD

  Community and Patient Preference Research Pty Ltd

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 6, 2021
• Study Start: November 8, 2021
• Primary Completion: February 27, 2022
• Study Completion: February 27, 2022
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)