Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes

March 29, 2022 updated by: Community and Patient Preference Research Pty Ltd

Impact of RYALTRIS® (Olopatadine Hydrochloride / Mometasone Furoate Monohydrate) Nasal Spray on Patients' Reported Outcomes

A real world evidence study that aims to understand the impact of RYALTRIS® nasal spray in patients with Allergic Rhinitis over a 28-day period.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The aim of this research is to develop a greater understanding of satisfaction with RYALTRIS® nasal spray in patients with Allergic Rhinitis (AR). There is currently no real-world evidence for patient satisfaction data with RYALTRIS® nasal spray. To address this knowledge gap and add to clinically relevant data to support Quality of Life (QoL) and patient reported outcomes, this research will evaluate the impact on quality of life (symptom control), using a Visual Analogue Scale (VAS), following initiation of RYALTRIS® to explore the relationship between baseline and subsequent QoL scores among patients initiated on RYALTRIS®.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Community and Patient Preference Research Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The primary population will be patients with moderate to severe Seasonal Allergic Rhinitis (SAR) or Perennial Allergic Rhinitis (PAR) in Australia who have been newly prescribed RYALTRIS® for management of their disease.

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with moderate to severe Allergic Rhinitis who have been prescribed RYALTRIS® nasal spray by their healthcare professional. Observational.
Other: 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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS)
Time Frame: 28 days
The primary study endpoint is the overall VAS score to determine improvement of Allergic Rhinitis symptoms and quality of life.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Allergic Rhinitis nasal symptoms
Time Frame: 28 days
Response to a visual analogue scale about their Allergic Rhinitis nasal symptoms
28 days
Overall Allergic Rhinitis ocular symptoms
Time Frame: 28 days
Response to a visual analogue scale about their Allergic Rhinitis ocular symptoms
28 days
Sleep quality
Time Frame: 28 days
Response to a visual analogue scale about their sleep quality
28 days
Daily outdoor activities
Time Frame: 28 days
Response to a visual analogue scale about their daily outdoor activities
28 days
Work productivity
Time Frame: 28 days
Response to a visual analogue scale about their work productivity
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Community and Patient Preference Research Pty Ltd

Collaborators

Seqirus Limited
Glenmark Pharmaceuticals

Investigators

  • Principal Investigator: Simon Fifer, PhD, Community and Patient Preference Research Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2021

Primary Completion (Actual)

March 14, 2022

Study Completion (Actual)

March 14, 2022

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210902_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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