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| Name | Class |
|---|---|
| Seqirus | INDUSTRY |
| Glenmark Pharmaceuticals S.A. | INDUSTRY |
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The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on RYALTRIS | Patients who are currently using RYALTRIS nasal spray. |
| |
| Patients on DYMISTA | Patients who are currently using DYMISTA nasal spray. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cross-sectional - through study completion, an average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Simon Fifer, PhD | Community and Patient Preference Research Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community and Patient Preference Research Pty Ltd | Sydney | New South Wales | 2000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 16086602 | Background | 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. | |
| 19144261 |
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As some eligible participants did not complete the online survey, more participants had to be recruited to meet the target sample size. This was done to ensure there was enough statistical power for analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients on RYALTRIS | Patients who are currently using RYALTRIS nasal spray. 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. |
| FG001 | Patients on DYMISTA | Patients who are currently using DYMISTA nasal spray. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As this was a non-interventional study, all participants were already initiated on their treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients on RYALTRIS | Patients who are currently using RYALTRIS nasal spray. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | Cross-sectional - through study completion, an average of 3 months |
|
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Adverse events data were not collected in this online observational survey as there were no open-text fields.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients on RYALTRIS | Patients who are currently using RYALTRIS nasal spray. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lili Toh | Community and Patient Preference Research (CaPPRe) | +61 452551409 | lili.toh@cappre.com.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2021 | Dec 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Cross-sectional - through study completion, an average of 3 months |
| Background |
| Meltzer 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. |
| 15692526 | Background | Meltzer 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. |
| 32782442 | Background | Price 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. |
| Background | Louviere, J., Flynn, T., Marley, A., 2015. References. In Best-Worst Scaling: Theory, Methods and Applications Cambridge University, Cambridge, pp. 316-331 |
| 26743636 | Background | 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. |
| BG001 |
| Patients on DYMISTA |
Patients who are currently using DYMISTA nasal spray. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Treatment Satisfaction Index | The Treatment Satisfaction Index measures overall satisfaction with the current treatment. The scale ranges from 0 to 100. Higher values represent greater overall satisfaction with the current treatment. | Mean | Standard Deviation | units on a scale ranging from 0 to 100. |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | Cross-sectional - through study completion, an average of 3 months |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Patients on DYMISTA | Patients who are currently using DYMISTA nasal spray. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Non-binary/gender fluid |
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| Prefer not to answer |
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| Satisfaction - Smell of medication |
|
| Satisfaction - Irritation to your nose |
|
| Satisfaction - Urge to sneeze |
|
| Satisfaction - Dripping out your nose/down your throat |
|
| Satisfaction - Dryness of your nose or throat |
|
| Satisfaction - Convenience (how easy it is to administer) |
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| Satisfaction - Fast acting (how quickly it works |
|
| Satisfaction - Duration of effect (long lasting) |
|
| Satisfaction - Perceived allergic rhinitis symptom control |
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| Importance - Immediate taste of medication |
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| Importance - Aftertaste of medication |
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| Importance - Smell of medication |
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| Importance - Irritation to your nose |
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| Importance - Urge to sneeze |
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| Importance - Dripping out your nose/down your throat |
|
| Importance - Dryness of your nose or throat |
|
| Importance - Convenience (how easy it is to administer) |
|
| Importance - Fast acting (how quickly it works) |
|
| Importance - Duration of effect (long lasting) |
|
| Importance - Perceived allergic rhinitis symptom control |
|