Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT06104332
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2023-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 534}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'URTI population : Effectiveness to improve nasal congestion', 'timeFrame': 'URTI: 3 days', 'description': 'URTI: Assess effectiveness to improve nasal congestion in real world usage (6-point Likert scale) 6-point-Likert scale: 0 (None) - 1 (Very mild) - 2 (Mild) - 3 (Moderate) - 4 (Strong) - 5 (Very strong). Higher score means a worse outcome'}, {'measure': 'AR population: Effectiveness to improve nasal congestion', 'timeFrame': 'AR: 7 days', 'description': 'Allergic Rhinitis (AR) : Assess effectiveness to improve nasal congestion in real world usage (6-point Likert scale) 6-point-Likert scale: 0 (None) - 1 (Very mild) - 2 (Mild) - 3 (Moderate) - 4 (Strong) - 5 (Very strong). Higher score means a worse outcome'}], 'secondaryOutcomes': [{'measure': 'Effectiveness to improve overall nasal symptoms (daytime)', 'timeFrame': 'URTI: Day 0 - Day 14', 'description': 'URTI: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale)'}, {'measure': 'Effectiveness to improve overall nasal symptoms (daytime)', 'timeFrame': 'AR: Day 0 - Day 21', 'description': 'AR: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale)'}, {'measure': 'Effectiveness to improve overall nasal symptoms (night-time)', 'timeFrame': 'URTI: Day 0 - Day 14', 'description': 'URTI: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage (6-point Likert scale)'}, {'measure': 'Effectiveness to improve overall nasal symptoms (night-time)', 'timeFrame': 'AR: Day 0 - Day 21', 'description': 'AR: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage'}, {'measure': 'Effectiveness to improve quality of life', 'timeFrame': 'URTI: Day 0 - Day 14', 'description': 'URTI: Assess effectiveness to improve quality of life in real world usage (RQLQ self-administered questionnaire)'}, {'measure': 'Effectiveness to improve quality of life', 'timeFrame': 'AR: Day 0 - Day 21', 'description': 'AR: Assess effectiveness to improve quality of life in real world usage (RQLQ self-administered questionnaire)'}, {'measure': 'Relief of nasal symptoms', 'timeFrame': 'AR: Day 1 - Day 21', 'description': 'AR : assessment of nasal symptoms relief (7-point Likert scale)'}, {'measure': 'Relief of nasal symptoms', 'timeFrame': 'URTI: Day 1 - Day 14', 'description': 'URTI: assessment of nasal symptoms relief (7-point Likert scale)'}, {'measure': 'Onset of action & Duration', 'timeFrame': 'URTI: Day 0 - Day 14', 'description': 'URTI: Assess Onset of action \\& Duration (2 closed questions)'}, {'measure': 'Onset of action & Duration', 'timeFrame': 'AR: Day 0 - Day 21', 'description': 'AR: Assess Onset of action \\& Duration (2 closed questions)'}, {'measure': 'Safety of the medical device', 'timeFrame': 'URTI: Day 0 - Day 14', 'description': 'URTI: occurence of incidents and deficiencies'}, {'measure': 'Tolerance', 'timeFrame': 'URTI: Day 14', 'description': 'URTI: 1 question (numeric scale : 0-10)'}, {'measure': 'Safety of the medical device', 'timeFrame': 'AR: Day 0 - Day 21', 'description': 'AR: occurence of incidents and deficiencies'}, {'measure': 'Tolerance', 'timeFrame': 'AR: Day 10 + Day 21', 'description': 'AR: 1 question (numeric scale: 0-10)'}, {'measure': 'Usage', 'timeFrame': 'URTI: Day 0 - Day 14', 'description': 'URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use'}, {'measure': 'Usage', 'timeFrame': 'AR: Day 0 - Day 21', 'description': 'AR: number of day of use, number of use/ day, number of puff/ nostril, moment of use'}, {'measure': 'Patient satisfaction', 'timeFrame': 'URTI: Day 14', 'description': 'URTI: 10 questions on Satisfaction (numeric scale: 0-10)'}, {'measure': 'Patient satisfaction', 'timeFrame': 'AR: Day 10 + Day 21', 'description': 'AR: 10 questions on Satisfaction (numeric scale: 0-10)'}, {'measure': 'Sensory profile', 'timeFrame': 'URTI: Day 14', 'description': 'URTI: 4 questions on sensory profile (numeric scale: 0-10)'}, {'measure': 'Sensory profile', 'timeFrame': 'AR: Day 10 + Day 21', 'description': 'AR: 4 questions on sensory profile (numeric scale: 0-10)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical device', 'Hypertonic seawater-based nasal spray'], 'conditions': ['Allergic Rhinitis', 'URTI']}, 'descriptionModule': {'briefSummary': 'The brief of this observational study is to evaluate usage, efficacy, safety and patient satisfaction of a range of hypertonic seawater-based decongestant nasal sprays in general population.\n\nThe main questions it aims to answer are:\n\n* Usage,\n* Efficacy,\n* Safety,\n* Satisfaction, in real-life usage with children, adults and pregnant or breastfeeding women. Participants will use the nasal spray as usual habits and complete daily questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General population coming to pharmacy for spontaneous purchase of a hypertonic seawater-based decongestant nasal spray for URTI or allergic rhinitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject coming to pharmacy for spontaneous purchase of one of the medical device under investigation.\n* Subject willing to buy one of the medical device under investigation following advice from pharmacist, general practitioner or any other health care professionals.\n* Adult and children from 3 years old in compliance with the information for use.\n* Subject presenting moderate nasal congestion or more.\n* Subject agreeing to follow the study requirements during the whole study period.\n* Subject having daily access to internet in order to answer online questionnaire.\n* Subject able to understand verbal and written local language and in capacity to fill-in questionnaire himself.\n* Subject able to give inform consent.\n\nExclusion Criteria:\n\n* Subject with contraindications according to the information for use.\n* Hypersensitivity or know allergy to any component of the product.\n* Subject taking part in another clinical study or being in the exclusion period of another clinical study.\n* Subject already included once in this study or having a family member already included in this study for the same indication.\n* Vulnerable subject (except children, pregnant and breastfeeding women).'}, 'identificationModule': {'nctId': 'NCT06104332', 'briefTitle': 'PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire de la Mer'}, 'officialTitle': 'Post-marketing Clinical Investigation to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays', 'orgStudyIdInfo': {'id': 'PMCF Hyper Mini'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ProRhinel Naturel spray nasal/ Allergic Rhinitis', 'interventionNames': ['Device: ProRhinel Naturel spray nasal/ Allergic rhinitis']}, {'label': 'ProRhinel Naturel spray nasal/ URTI', 'interventionNames': ['Device: ProRhinel Naturel spray nasal/ URTI']}, {'label': 'ProRhinel EXTRA Eucalyptus spray nasal/ URTI', 'interventionNames': ['Device: ProRhinel EXTRA Eucalyptus spray nasal']}, {'label': 'RESPIMER Enfant/ URTI', 'interventionNames': ['Device: RESPIMER Enfant']}, {'label': 'Phytosun Aroms spray nasal MAX/ URTI', 'interventionNames': ['Device: Phytosun Aroms spray nasal MAX']}, {'label': 'PHYSIOMER RHUME TRIPLE ACTION/ URTI', 'interventionNames': ['Device: PHYSIOMER RHUME TRIPLE ACTION']}, {'label': 'Phytosun Aroms spray nasal decongestionnant/ URTI', 'interventionNames': ['Device: Phytosun Aroms spray nasal decongestionnant']}], 'interventions': [{'name': 'ProRhinel Naturel spray nasal/ Allergic rhinitis', 'type': 'DEVICE', 'description': 'ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day', 'armGroupLabels': ['ProRhinel Naturel spray nasal/ Allergic Rhinitis']}, {'name': 'ProRhinel EXTRA Eucalyptus spray nasal', 'type': 'DEVICE', 'description': 'ProRhinel EXTRA Eucalyptus spray nasal: until resolution of symptoms (period of 14 days maximum) ; 2 to 3 sprays per nostril; 6 times per day maximum', 'armGroupLabels': ['ProRhinel EXTRA Eucalyptus spray nasal/ URTI']}, {'name': 'RESPIMER Enfant', 'type': 'DEVICE', 'description': 'RESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum', 'armGroupLabels': ['RESPIMER Enfant/ URTI']}, {'name': 'Phytosun Aroms spray nasal MAX', 'type': 'DEVICE', 'description': 'Phytosun Aroms spray nasal MAX: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day', 'armGroupLabels': ['Phytosun Aroms spray nasal MAX/ URTI']}, {'name': 'PHYSIOMER RHUME TRIPLE ACTION', 'type': 'DEVICE', 'description': 'PHYSIOMER RHUME TRIPLE ACTION: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day', 'armGroupLabels': ['PHYSIOMER RHUME TRIPLE ACTION/ URTI']}, {'name': 'Phytosun Aroms spray nasal decongestionnant', 'type': 'DEVICE', 'description': 'Phytosun Aroms spray nasal decongestionnant : until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 6 times per day maximum', 'armGroupLabels': ['Phytosun Aroms spray nasal decongestionnant/ URTI']}, {'name': 'ProRhinel Naturel spray nasal/ URTI', 'type': 'DEVICE', 'description': 'ProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day', 'armGroupLabels': ['ProRhinel Naturel spray nasal/ URTI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Honfleur', 'country': 'France', 'facility': 'Alexandra Crevecoeur', 'geoPoint': {'lat': 49.41985, 'lon': 0.23294}}, {'city': 'Vern-sur-Seiche', 'country': 'France', 'facility': 'Annie Le Gall', 'geoPoint': {'lat': 48.04585, 'lon': -1.60242}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire de la Mer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Slb Pharma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}