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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05129306




Registration number
NCT05129306
Ethics application status
Date submitted
10/11/2021
Date registered
22/11/2021

Titles & IDs
Public title
Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes
Scientific title
Impact of RYALTRIS® (Olopatadine Hydrochloride / Mometasone Furoate Monohydrate) Nasal Spray on Patients' Reported Outcomes
Secondary ID [1] 0 0
20210902_1
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 - Patients with moderate to severe Allergic Rhinitis who have been prescribed RYALTRIS® nasal spray by their healthcare professional. Observational.


Other interventions: Observational
In this observational study, participants with moderate to severe Allergic Rhinitis who were initiated on Ryaltris® nasal spray by their healthcare professional will complete an online survey before commencement of treatment and then at days 1, 7, and 14 from treatment initiation. Survey completion at day 28 after treatment initiation will be optional for participants based on ongoing use of RYALTRIS®.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual analogue scale (VAS)
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Overall Allergic Rhinitis nasal symptoms
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Overall Allergic Rhinitis ocular symptoms
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Sleep quality
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Daily outdoor activities
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Work productivity
Timepoint [5] 0 0
28 days

Eligibility
Key inclusion criteria
AR patients (moderate-to-severe SAR or PAR) 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 newly prescribed RYALTRIS® who have not yet initiated 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?
No
Key exclusion criteria
Potential participants will be excluded if they:

* 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)
* are currently or have previously been on RYALTRIS®

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/03/2022
Sample size
Target
Accrual to date
Final
0
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
Other
Name [1] 0 0
Seqirus Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Glenmark Pharmaceuticals
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05129306