Clinical trial NCT05146206: Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray
Official title: Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments for Allergic Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Keywords: Patient preference
Best-Worst Scaling
Treatment attributes
Lead sponsor: Community and Patient Preference Research Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Seqirus
name: Glenmark Pharmaceuticals S.A.
First posted: 2021-12-06
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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®).

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

To directly compare patient satisfaction with 2 different Allergic Rhinitis nasal sprays, an observational, cross-sectional study design with 2 independent samples was chosen. Participants will complete an online survey involving a Best-Worst scaling (BWS) task to determine satisfaction and importance index for sensory attributes.

The suggested treatment attributes are informed by a range of previous studies, including those conducted by Meltzer et al 2005 and Price et al 2020, and methodology from CaPPRe's own work in developing indices for importance and satisfaction of treatment attributes using BWS.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score)
timeFrame: Cross-sectional - through study completion, an average of 3 months
Secondary outcomes:
measure: Rescaled Scores From Best-Worst Scaling Task
timeFrame: Cross-sectional - through study completion, an average of 3 months
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, 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.
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.
citation: Louviere, J., Flynn, T., Marley, A., 2015. References. In Best-Worst Scaling: Theory, Methods and Applications Cambridge University, Cambridge, pp. 316-331
citation: 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.