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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05146206
Ethics application status
Date submitted
10/11/2021
Date registered
6/12/2021

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
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05146206