An observational study in Allergic Rhinitis, sponsored by Community and Patient Preference Research Pty Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Community and Patient Preference Research Pty Ltd · Observational
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 426 is above the median of 141 across 172 observational studies indexed under Rhinitis.
Browse Rhinitis studies →Community and Patient Preference Research Pty Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
Patients who are currently using RYALTRIS nasal spray.
Other: Observational
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.
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.
Time frame: Cross-sectional - through study completion, an average of 3 months
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.
Time frame: Cross-sectional - through study completion, an average of 3 months
| Milestone | Patients on RYALTRIS | Patients on DYMISTA |
|---|---|---|
| Started | 98 | 328 |
| Completed | 98 | 328 |
| Not completed | 0 | 0 |
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.
| units on a scale | Participants Using Ryaltris (OLO/MOM) | Participants Using Dymista (AZE/FLU) |
|---|---|---|
| Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score) | 68.26 ± 1.39 | 62.78 ± 0.70 |
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.
| units on a scale | Participants Using Ryaltris (OLO/MOM) | Participants Using Dymista (AZE/FLU) |
|---|---|---|
| Satisfaction - Immediate taste of medication | 6.12 ± 0.62 | 4.66 ± 0.26 |
| Satisfaction - Aftertaste of medication | 5.84 ± 0.59 | 4.21 ± 0.23 |
| Satisfaction - Smell of medication | 6.31 ± 0.64 | 5.55 ± 0.31 |
| Satisfaction - Irritation to your nose | 6.05 ± 0.61 | 5.37 ± 0.30 |
| Satisfaction - Urge to sneeze | 6.35 ± 0.64 | 5.52 ± 0.30 |
| Satisfaction - Dripping out your nose/down your throat | 6.20 ± 0.63 | 4.89 ± 0.27 |
| Satisfaction - Dryness of your nose or throat | 6.41 ± 0.65 | 5.64 ± 0.31 |
| Satisfaction - Convenience (how easy it is to administer) | 7.31 ± 0.74 | 7.15 ± 0.39 |
| Satisfaction - Fast acting (how quickly it works | 7.55 ± 0.76 | 7.16 ± 0.40 |
| Satisfaction - Duration of effect (long lasting) | 7.30 ± 0.74 | 6.89 ± 0.38 |
| Satisfaction - Perceived allergic rhinitis symptom control | 7.38 ± 0.75 | 7.96 ± 0.44 |
| Importance - Immediate taste of medication | 5.84 ± 0.59 | 4.63 ± 0.26 |
| Importance - Aftertaste of medication | 5.59 ± 0.56 | 4.80 ± 0.27 |
| Importance - Smell of medication | 5.20 ± 0.53 | 3.41 ± 0.19 |
| Importance - Irritation to your nose | 6.08 ± 0.61 | 5.51 ± 0.30 |
| Importance - Urge to sneeze | 5.88 ± 0.59 | 4.69 ± 0.26 |
| Importance - Dripping out your nose/down your throat | 6.29 ± 0.64 | 5.43 ± 0.30 |
| Importance - Dryness of your nose or throat | 6.28 ± 0.63 | 5.49 ± 0.30 |
| Importance - Convenience (how easy it is to administer) | 6.65 ± 0.67 | 6.17 ± 0.34 |
| Importance - Fast acting (how quickly it works) | 7.35 ± 0.74 | 7.48 ± 0.41 |
| Importance - Duration of effect (long lasting) | 7.34 ± 0.74 | 7.70 ± 0.43 |
| Importance - Perceived allergic rhinitis symptom control | 8.00 ± 0.81 | 8.86 ± 0.49 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients on RYALTRIS | — | — | — |
| Patients on DYMISTA | — | — | — |
As this was a non-interventional study, all participants were already initiated on their treatment.
| Age, Categorical(Participants) | Patients on RYALTRIS | Patients on DYMISTA | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 92 | 292 | 384 |
| >=65 years | 6 | 36 | 42 |
| Sex/Gender, Customized(Participants) | Patients on RYALTRIS | Patients on DYMISTA | Total |
|---|---|---|---|
| Gender — Female | 44 | 249 | 293 |
| Gender — Male | 54 | 77 | 131 |
| Gender — Non-binary/gender fluid | 0 | 1 | 1 |
| Gender — Prefer not to answer | 0 | 1 | 1 |
| Race and Ethnicity Not Collected(Participants) | Patients on RYALTRIS | Patients on DYMISTA | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Treatment Satisfaction Index(units on a scale ranging from 0 to 100.) | Patients on RYALTRIS | Patients on DYMISTA | Total |
|---|---|---|---|
| Mean | 68.26 ± 13.76 | 62.78 ± 12.60 | 64.04 ± 13.07 |
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Community and Patient Preference Research Pty Ltd