Allergic RhinitisNCT05146206
Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray
An observational study of Allergic Rhinitis, run by Community and Patient Preference Research Pty Ltd at 1 site in Australia.
Trial summary
The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Observational
- How many people
- 426 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Nov 2021to 27 Feb 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Community and Patient Preference Research Pty Ltd
Sydney, New South Wales, 2000
About this study
Official title: 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®).
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Observational
- Keywords
- Patient preference, Best-Worst Scaling, Treatment attributes
- Medical subject headings
- Rhinitis, Allergic, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients on RYALTRIS | Patients who are currently using RYALTRIS nasal spray. Receives: Other: Observational | |
| Patients on DYMISTA | Patients who are currently using DYMISTA nasal spray. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score)
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.
Measured: Cross-sectional - through study completion, an average of 3 months
Secondary outcomes (1)
Rescaled Scores From Best-Worst Scaling Task
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.
Measured: Cross-sectional - through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start8 Nov 2021
- Primary completion27 Feb 2022
- Study completion27 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community and Patient Preference Research Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seqirus, Glenmark Pharmaceuticals S.A.
- Responsible party
- Sponsor
- Investigators
- Simon Fifer, PhD, Principal investigator, Community and Patient Preference Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146206
- Sponsor's protocol ID
- 20210902_2
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2021
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16086602Meltzer 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.
PubMed 19144261Meltzer 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.
PubMed 15692526Price 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.
PubMed 32782442Louviere, 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.
PubMed 26743636
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments for Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05146206
- Acronym / sponsor ID
- 20210902_2
- Conditions
- Allergic Rhinitis
- Keywords
- Patient preference, Best-Worst Scaling, Treatment attributes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Community and Patient Preference Research Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seqirus, Glenmark Pharmaceuticals S.A.
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Posted 12 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®).
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients on RYALTRIS | – | Other: ObservationalPatients who are currently using RYALTRIS nasal spray. |
| Patients on DYMISTA | – | Other: ObservationalPatients who are currently using DYMISTA nasal spray. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalIn 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. | Other | Patients on DYMISTA, Patients on RYALTRIS |
Primary outcome
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.
1 secondary outcome
Rescaled Scores From Best-Worst Scaling Task
Time frame: Cross-sectional - through study completion, an average of 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAustralian 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
- Background: PubMed 16086602Meltzer 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.
- Background: PubMed 19144261Meltzer 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.
- Background: PubMed 15692526Meltzer 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.
- Background: PubMed 32782442Price 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.
- BackgroundLouviere, J., Flynn, T., Marley, A., 2015. References. In Best-Worst Scaling: Theory, Methods and Applications Cambridge University, Cambridge, pp. 316-331
- Background: PubMed 26743636Muhlbacher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Fifer, PhD principal investigator
Community and Patient Preference Research Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Community and Patient Preference Research Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score) (time frame: Cross-sectional - through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05146206, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.