Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray

April 7, 2024 updated by: Community and Patient Preference Research Pty Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

426

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

Yes

Sampling Method

Non-Probability Sample

Study Population

The primary population will be patients with moderate to severe SAR or PAR with or without conjunctivitis in Australia who have been initiated on RYALTRIS® or DYMISTA® in that last 12 months.

The expected sample size is between 200 to 400 patients. 100-200 patients initiated on RYALTRIS® and 100-200 patients initiated on DYMISTA® nasal spray in the last 12 months.

Description

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)

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-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients on RYALTRIS
Patients who are currently using RYALTRIS nasal spray.
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.
Patients on DYMISTA
Patients who are currently using DYMISTA nasal spray.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score)
Time Frame: Cross-sectional - through study completion, an average of 3 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescaled Scores From Best-Worst Scaling Task
Time Frame: Cross-sectional - through study completion, an average of 3 months

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

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
Glenmark Pharmaceuticals S.A.

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 8, 2021

Primary Completion (Actual)

February 27, 2022

Study Completion (Actual)

February 27, 2022

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210902_2

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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