Trial Outcomes & Findings for Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray (NCT NCT05146206)

Last Updated: 2024-04-12

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

426 participants

Primary outcome timeframe

Cross-sectional - through study completion, an average of 3 months

Results posted on

2024-04-12

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	98	328
Overall Study COMPLETED	98	328
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients on RYALTRIS n=98 Participants 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.	Patients on DYMISTA n=328 Participants 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.	Total n=426 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=98 Participants	0 Participants n=328 Participants	0 Participants n=426 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=98 Participants	292 Participants n=328 Participants	384 Participants n=426 Participants
Age, Categorical >=65 years	6 Participants n=98 Participants	36 Participants n=328 Participants	42 Participants n=426 Participants
Sex/Gender, Customized Gender · Female	44 Participants n=98 Participants	249 Participants n=328 Participants	293 Participants n=426 Participants
Sex/Gender, Customized Gender · Male	54 Participants n=98 Participants	77 Participants n=328 Participants	131 Participants n=426 Participants
Sex/Gender, Customized Gender · Non-binary/gender fluid	0 Participants n=98 Participants	1 Participants n=328 Participants	1 Participants n=426 Participants
Sex/Gender, Customized Gender · Prefer not to answer	0 Participants n=98 Participants	1 Participants n=328 Participants	1 Participants n=426 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Treatment Satisfaction Index	68.26 units on a scale ranging from 0 to 100. STANDARD_DEVIATION 13.76 • n=98 Participants	62.78 units on a scale ranging from 0 to 100. STANDARD_DEVIATION 12.60 • n=328 Participants	64.04 units on a scale ranging from 0 to 100. STANDARD_DEVIATION 13.07 • n=426 Participants

PRIMARY outcome

Timeframe: Cross-sectional - through study completion, an average of 3 months

Outcome measures

Outcome measures
Measure	Participants Using Ryaltris (OLO/MOM) n=98 Participants Participants using Ryaltris (OLO/MOM)	Participants Using Dymista (AZE/FLU) n=328 Participants Participants using Dymista (AZE/FLU)
Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score)	68.26 units on a scale Standard Error 1.39	62.78 units on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants Using Ryaltris (OLO/MOM) n=98 Participants Participants using Ryaltris (OLO/MOM)	Participants Using Dymista (AZE/FLU) n=328 Participants Participants using Dymista (AZE/FLU)
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Immediate taste of medication	6.12 units on a scale Standard Error 0.62	4.66 units on a scale Standard Error 0.26
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Aftertaste of medication	5.84 units on a scale Standard Error 0.59	4.21 units on a scale Standard Error 0.23
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Smell of medication	6.31 units on a scale Standard Error 0.64	5.55 units on a scale Standard Error 0.31
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Irritation to your nose	6.05 units on a scale Standard Error 0.61	5.37 units on a scale Standard Error 0.30
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Urge to sneeze	6.35 units on a scale Standard Error 0.64	5.52 units on a scale Standard Error 0.30
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Dripping out your nose/down your throat	6.20 units on a scale Standard Error 0.63	4.89 units on a scale Standard Error 0.27
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Dryness of your nose or throat	6.41 units on a scale Standard Error 0.65	5.64 units on a scale Standard Error 0.31
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Convenience (how easy it is to administer)	7.31 units on a scale Standard Error 0.74	7.15 units on a scale Standard Error 0.39
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Fast acting (how quickly it works	7.55 units on a scale Standard Error 0.76	7.16 units on a scale Standard Error 0.40
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Duration of effect (long lasting)	7.30 units on a scale Standard Error 0.74	6.89 units on a scale Standard Error 0.38
Rescaled Scores From Best-Worst Scaling Task Satisfaction - Perceived allergic rhinitis symptom control	7.38 units on a scale Standard Error 0.75	7.96 units on a scale Standard Error 0.44
Rescaled Scores From Best-Worst Scaling Task Importance - Immediate taste of medication	5.84 units on a scale Standard Error 0.59	4.63 units on a scale Standard Error 0.26
Rescaled Scores From Best-Worst Scaling Task Importance - Aftertaste of medication	5.59 units on a scale Standard Error 0.56	4.80 units on a scale Standard Error 0.27
Rescaled Scores From Best-Worst Scaling Task Importance - Smell of medication	5.20 units on a scale Standard Error 0.53	3.41 units on a scale Standard Error 0.19
Rescaled Scores From Best-Worst Scaling Task Importance - Irritation to your nose	6.08 units on a scale Standard Error 0.61	5.51 units on a scale Standard Error 0.30
Rescaled Scores From Best-Worst Scaling Task Importance - Urge to sneeze	5.88 units on a scale Standard Error 0.59	4.69 units on a scale Standard Error 0.26
Rescaled Scores From Best-Worst Scaling Task Importance - Dripping out your nose/down your throat	6.29 units on a scale Standard Error 0.64	5.43 units on a scale Standard Error 0.30
Rescaled Scores From Best-Worst Scaling Task Importance - Dryness of your nose or throat	6.28 units on a scale Standard Error 0.63	5.49 units on a scale Standard Error 0.30
Rescaled Scores From Best-Worst Scaling Task Importance - Convenience (how easy it is to administer)	6.65 units on a scale Standard Error 0.67	6.17 units on a scale Standard Error 0.34
Rescaled Scores From Best-Worst Scaling Task Importance - Fast acting (how quickly it works)	7.35 units on a scale Standard Error 0.74	7.48 units on a scale Standard Error 0.41
Rescaled Scores From Best-Worst Scaling Task Importance - Duration of effect (long lasting)	7.34 units on a scale Standard Error 0.74	7.70 units on a scale Standard Error 0.43
Rescaled Scores From Best-Worst Scaling Task Importance - Perceived allergic rhinitis symptom control	8.00 units on a scale Standard Error 0.81	8.86 units on a scale Standard Error 0.49

Adverse Events

Patients on RYALTRIS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients on DYMISTA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Lili Toh

Community and Patient Preference Research (CaPPRe)

Phone: +61 452551409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place