Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-31 @ 11:29 AM
Study NCT ID:
NCT05146206
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lili.toh@cappre.com.au', 'phone': '+61 452551409', 'title': 'Dr Lili Toh', 'organization': 'Community and Patient Preference Research (CaPPRe)'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Adverse events data were not collected in this online observational survey as there were no open-text fields.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients on RYALTRIS', 'description': 'Patients who are currently using RYALTRIS nasal spray.\n\nObservational: 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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients on DYMISTA', 'description': 'Patients who are currently using DYMISTA nasal spray.\n\nObservational: 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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Using Ryaltris (OLO/MOM)', 'description': 'Participants using Ryaltris (OLO/MOM)'}, {'id': 'OG001', 'title': 'Participants Using Dymista (AZE/FLU)', 'description': 'Participants using Dymista (AZE/FLU)'}], 'classes': [{'categories': [{'measurements': [{'value': '68.26', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '62.78', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional - through study completion, an average of 3 months', 'description': '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.\n\nIndex scores from the Best Worst Scaling exercise range from 0 to 100, with higher scores indicating higher satisfaction of treatment attributes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rescaled Scores From Best-Worst Scaling Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Using Ryaltris (OLO/MOM)', 'description': 'Participants using Ryaltris (OLO/MOM)'}, {'id': 'OG001', 'title': 'Participants Using Dymista (AZE/FLU)', 'description': 'Participants using Dymista (AZE/FLU)'}], 'classes': [{'title': 'Satisfaction - Immediate taste of medication', 'categories': [{'measurements': [{'value': '6.12', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '4.66', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Aftertaste of medication', 'categories': [{'measurements': [{'value': '5.84', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Smell of medication', 'categories': [{'measurements': [{'value': '6.31', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '5.55', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Irritation to your nose', 'categories': [{'measurements': [{'value': '6.05', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '5.37', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Urge to sneeze', 'categories': [{'measurements': [{'value': '6.35', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '5.52', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Dripping out your nose/down your throat', 'categories': [{'measurements': [{'value': '6.20', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '4.89', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Dryness of your nose or throat', 'categories': [{'measurements': [{'value': '6.41', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '5.64', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Convenience (how easy it is to administer)', 'categories': [{'measurements': [{'value': '7.31', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '7.15', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Fast acting (how quickly it works', 'categories': [{'measurements': [{'value': '7.55', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Duration of effect (long lasting)', 'categories': [{'measurements': [{'value': '7.30', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '6.89', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction - Perceived allergic rhinitis symptom control', 'categories': [{'measurements': [{'value': '7.38', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '7.96', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Immediate taste of medication', 'categories': [{'measurements': [{'value': '5.84', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '4.63', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Aftertaste of medication', 'categories': [{'measurements': [{'value': '5.59', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Smell of medication', 'categories': [{'measurements': [{'value': '5.20', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Irritation to your nose', 'categories': [{'measurements': [{'value': '6.08', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Urge to sneeze', 'categories': [{'measurements': [{'value': '5.88', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Dripping out your nose/down your throat', 'categories': [{'measurements': [{'value': '6.29', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '5.43', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Dryness of your nose or throat', 'categories': [{'measurements': [{'value': '6.28', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '5.49', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Convenience (how easy it is to administer)', 'categories': [{'measurements': [{'value': '6.65', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '6.17', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Fast acting (how quickly it works)', 'categories': [{'measurements': [{'value': '7.35', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '7.48', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Duration of effect (long lasting)', 'categories': [{'measurements': [{'value': '7.34', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '7.70', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Importance - Perceived allergic rhinitis symptom control', 'categories': [{'measurements': [{'value': '8.00', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '8.86', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'MANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Cross-sectional - through study completion, an average of 3 months', 'description': '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).\n\nRescaled 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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients on RYALTRIS', 'description': 'Patients who are currently using RYALTRIS nasal spray.\n\nObservational: 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.'}, {'id': 'FG001', 'title': 'Patients on DYMISTA', 'description': 'Patients who are currently using DYMISTA nasal spray.\n\nObservational: 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '328'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients on RYALTRIS', 'description': 'Patients who are currently using RYALTRIS nasal spray.\n\nObservational: 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.'}, {'id': 'BG001', 'title': 'Patients on DYMISTA', 'description': 'Patients who are currently using DYMISTA nasal spray.\n\nObservational: 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Non-binary/gender fluid', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Treatment Satisfaction Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.26', 'spread': '13.76', 'groupId': 'BG000'}, {'value': '62.78', 'spread': '12.60', 'groupId': 'BG001'}, {'value': '64.04', 'spread': '13.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'units on a scale ranging from 0 to 100.', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'As this was a non-interventional study, all participants were already initiated on their treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-14', 'size': 476820, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-01T00:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 426}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2021-11-10', 'resultsFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-07', 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Best-Worst Scaling Task Index Score (Treatment Satisfaction Index Score)', 'timeFrame': 'Cross-sectional - through study completion, an average of 3 months', 'description': '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.\n\nIndex scores from the Best Worst Scaling exercise range from 0 to 100, with higher scores indicating higher satisfaction of treatment attributes.'}], 'secondaryOutcomes': [{'measure': 'Rescaled Scores From Best-Worst Scaling Task', 'timeFrame': 'Cross-sectional - through study completion, an average of 3 months', 'description': '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).\n\nRescaled 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient preference', 'Best-Worst Scaling', 'Treatment attributes'], 'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "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"}, {'pmid': '16086602', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19144261', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15692526', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32782442', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Louviere, J., Flynn, T., Marley, A., 2015. References. In Best-Worst Scaling: Theory, Methods and Applications Cambridge University, Cambridge, pp. 316-331'}, {'pmid': '26743636', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®).", 'detailedDescription': "The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®).\n\nTo 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nThe 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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAllergic 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:\n\n* Patients above 18 years old\n* Fluent in English\n* Patients initiated on RYALTRIS® or DYMISTA® nasal spray in the last 12 months and currently using treatment\n* Willing and able to provide consent to participate\n\nExclusion Criteria:\n\n* Have reported a loss of taste and/or smell related to COVID-19 (or other medical condition)\n* Are employed by a pharmaceutical company (to avoid conflict of interest)\n* Are employed by a vaccine company (to avoid conflict of interest)\n* Do not have access to the internet (to ensure validity of the data)\n* Are unable to read and understand English (to ensure validity of the data)'}, 'identificationModule': {'nctId': 'NCT05146206', 'briefTitle': 'Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray', 'organization': {'class': 'INDUSTRY', 'fullName': 'Community and Patient Preference Research Pty Ltd'}, 'officialTitle': 'Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments for Allergic Rhinitis', 'orgStudyIdInfo': {'id': '20210902_2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients on RYALTRIS', 'description': 'Patients who are currently using RYALTRIS nasal spray.', 'interventionNames': ['Other: Observational']}, {'label': 'Patients on DYMISTA', 'description': 'Patients who are currently using DYMISTA nasal spray.', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Patients on DYMISTA', 'Patients on RYALTRIS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Community and Patient Preference Research Pty Ltd', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Simon Fifer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community and Patient Preference Research Pty Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Community and Patient Preference Research Pty Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Seqirus', 'class': 'INDUSTRY'}, {'name': 'Glenmark Pharmaceuticals S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}