Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 10:54 AM
Study NCT ID:
NCT05129306
Status:
WITHDRAWN
Last Update Posted:
2022-04-07
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Difficulty recruiting participants with current strategy', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale (VAS)', 'timeFrame': '28 days', 'description': 'The primary study endpoint is the overall VAS score to determine improvement of Allergic Rhinitis symptoms and quality of life.'}], 'secondaryOutcomes': [{'measure': 'Overall Allergic Rhinitis nasal symptoms', 'timeFrame': '28 days', 'description': 'Response to a visual analogue scale about their Allergic Rhinitis nasal symptoms'}, {'measure': 'Overall Allergic Rhinitis ocular symptoms', 'timeFrame': '28 days', 'description': 'Response to a visual analogue scale about their Allergic Rhinitis ocular symptoms'}, {'measure': 'Sleep quality', 'timeFrame': '28 days', 'description': 'Response to a visual analogue scale about their sleep quality'}, {'measure': 'Daily outdoor activities', 'timeFrame': '28 days', 'description': 'Response to a visual analogue scale about their daily outdoor activities'}, {'measure': 'Work productivity', 'timeFrame': '28 days', 'description': 'Response to a visual analogue scale about their work productivity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient outcomes', 'Patient satisfaction', 'Quality of Life'], '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': '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.'}]}, 'descriptionModule': {'briefSummary': 'A real world evidence study that aims to understand the impact of RYALTRIS® nasal spray in patients with Allergic Rhinitis over a 28-day period.', 'detailedDescription': 'The aim of this research is to develop a greater understanding of satisfaction with RYALTRIS® nasal spray in patients with Allergic Rhinitis (AR). There is currently no real-world evidence for patient satisfaction data with RYALTRIS® nasal spray. To address this knowledge gap and add to clinically relevant data to support Quality of Life (QoL) and patient reported outcomes, this research will evaluate the impact on quality of life (symptom control), using a Visual Analogue Scale (VAS), following initiation of RYALTRIS® to explore the relationship between baseline and subsequent QoL scores among patients initiated on RYALTRIS®.'}, '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 Seasonal Allergic Rhinitis (SAR) or Perennial Allergic Rhinitis (PAR) in Australia who have been newly prescribed RYALTRIS® for management of their disease.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAR patients (moderate-to-severe SAR or PAR) 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 newly prescribed RYALTRIS® who have not yet initiated treatment\n* Willing and able to provide consent to participate\n\nExclusion Criteria:\n\nPotential participants will be excluded if they:\n\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)\n* are currently or have previously been on RYALTRIS®'}, 'identificationModule': {'nctId': 'NCT05129306', 'briefTitle': "Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes", 'organization': {'class': 'INDUSTRY', 'fullName': 'Community and Patient Preference Research Pty Ltd'}, 'officialTitle': "Impact of RYALTRIS® (Olopatadine Hydrochloride / Mometasone Furoate Monohydrate) Nasal Spray on Patients' Reported Outcomes", 'orgStudyIdInfo': {'id': '20210902_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with moderate to severe Allergic Rhinitis who have been prescribed RYALTRIS® nasal spray by their healthcare professional. Observational.', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'In this observational study, participants with moderate to severe Allergic Rhinitis who were initiated on Ryaltris® nasal spray by their healthcare professional will complete an online survey before commencement of treatment and then at days 1, 7, and 14 from treatment initiation. Survey completion at day 28 after treatment initiation will be optional for participants based on ongoing use of RYALTRIS®.', 'armGroupLabels': ['Patients']}]}, '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 Limited', 'class': 'UNKNOWN'}, {'name': 'Glenmark Pharmaceuticals', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}