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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05146206




Registration number
NCT05146206
Ethics application status
Date submitted
10/11/2021
Date registered
6/12/2021
Date last updated
12/04/2024

Titles & IDs
Public title
Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray
Scientific title
Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments for Allergic Rhinitis
Secondary ID [1] 0 0
20210902_2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Observational

Patients on RYALTRIS - Patients who are currently using RYALTRIS nasal spray.

Patients on DYMISTA - Patients who are currently using DYMISTA nasal spray.


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score)
Timepoint [1] 0 0
Cross-sectional - through study completion, an average of 3 months
Secondary outcome [1] 0 0
Rescaled Scores From Best-Worst Scaling Task
Timepoint [1] 0 0
Cross-sectional - through study completion, an average of 3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/02/2022
Sample size
Target
Accrual to date
Final
426
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Community and Patient Preference Research Pty Ltd - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Community and Patient Preference Research Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Seqirus
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Glenmark Pharmaceuticals S.A.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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®).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05146206
Trial related presentations / publications
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
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.
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.
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.
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.
Louviere, J., Flynn, T., Marley, A., 2015. References. In Best-Worst Scaling: Theory, Methods and Applications Cambridge University, Cambridge, pp. 316-331
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.
Public notes

Contacts
Principal investigator
Name 0 0
Simon Fifer, PhD
Address 0 0
Community and Patient Preference Research Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05146206