Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray

Allergic Rhinitis Clinical Trial

Official title:

Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments for Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05146206
• Other study ID #: 20210902_2
• Status: Completed
• Start date: November 8, 2021
• Est. completion date: February 27, 2022

Study information

• Verified date: April 2024
• Source: Community and Patient Preference Research Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: February 27, 2022
• Est. primary completion date: February 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• Observational
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.

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 S.A., Seqirus

Country where clinical trial is conducted

Australia, 

References & 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

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

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. — View 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. — 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. doi: 10.1016/j.otohns.2004.10.010. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rescaled Scores From Best-Worst Scaling Task	Secondary study endpoints were the rescaled Best Worst Scaling domain scores from the Best Worst Scaling exercise (i.e., scores for each of the domains on satisfaction and importance).; Rescaled Best-Worst Scaling domain scores range from 0 to 10 and represent the satisfaction and importance of each domain. Higher satisfaction rescaled scores indicate higher satisfaction on a treatment attribute. Higher importance rescaled scores indicate higher importance of the treatment attribute. Higher rescaled satisfaction and importance scores suggest a better outcome since participants are satisfied and more likely to adhere to their current treatment.	Cross-sectional - through study completion, an average of 3 months