Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-04-22 @ 1:58 AM
Study NCT ID:
NCT03251066
Status:
COMPLETED
Last Update Posted:
2017-08-21
First Post:
2017-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Effect of Proponent-Nasal-Spray on Unspecific Discomfort in the Nose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Every participant of the study will specify at the beginning of the investigation his subjective starting situation concerning the nasal discomfort.The participant records his/ her personal impression on the change of severity of the general symptoms or selected individual symptoms of unspecific nasal discomfort following the single administration of "Proponent Nasal Spray". Every Patient serves as his own control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2017-08-11', 'lastUpdatePostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the safety endpoint (adverse events non-response rate).', 'timeFrame': 'up to 48 hrs', 'description': 'This endpont is defined by the adverse events non-response rate based on the individual adverse events reported by the participant up to 60 min after treatment. The adverse events are specified and defined by scores. The sum score over time for all individual adverse event symptoms will be determined for each participant. Not more than 10 % of all participants of the study should report adverse events with a sum score \\> 3 for one or more of the listed adverse events. Not more than 10 % of all participants of the study should report adverse events with a sum score \\> 3 for one or more of the listed adverse effects.'}], 'secondaryOutcomes': [{'measure': 'The secondary endpoints of the study are the immediate response rate based on the "Change of severity of general and selected individual symptoms of unspecific nasal discomfort".', 'timeFrame': 'up to 48 hrs', 'description': 'The first co-secondary endpoint of the study is the immediate response rate based on the "Change of severity of general symptoms of unspecific nasal discomfort" following the single administration of "Proponent Nasal Spray" up to 60 min after treatment. The second co-secondary endpoint is the immediate response rate based on the "Change of severity of selected individual symptoms" of nasal discomfort following the single administration of "Proponent Nasal Spray" up to 60 min after treatment - provided the respective symptom was identified by a participant prior to the administration of "Proponent Nasal Spray" as a nasal discomfort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nose Saline Solution Irrigation Nasal Spray', 'Sodium propionate Locke-Ringer Solution'], 'conditions': ['Unspecified Disorder of Nose and Nasal Sinuses']}, 'referencesModule': {'references': [{'pmid': '24390308', 'type': 'RESULT', 'citation': 'Trompette A, Gollwitzer ES, Yadava K, Sichelstiel AK, Sprenger N, Ngom-Bru C, Blanchard C, Junt T, Nicod LP, Harris NL, Marsland BJ. Gut microbiota metabolism of dietary fiber influences allergic airway disease and hematopoiesis. Nat Med. 2014 Feb;20(2):159-66. doi: 10.1038/nm.3444. Epub 2014 Jan 5.'}, {'pmid': '21865681', 'type': 'RESULT', 'citation': 'Brandtzaeg P. Immune functions of nasopharyngeal lymphoid tissue. Adv Otorhinolaryngol. 2011;72:20-4. doi: 10.1159/000324588. Epub 2011 Aug 18.'}, {'pmid': '23354530', 'type': 'RESULT', 'citation': 'Achilles N, Mosges R. Nasal saline irrigations for the symptoms of acute and chronic rhinosinusitis. Curr Allergy Asthma Rep. 2013 Apr;13(2):229-35. doi: 10.1007/s11882-013-0339-y.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of the immediate effect on subjective relief of symptoms by Proponent - Nasal - Spray after a one time administration (following a single dose administration in each nostril) in an open, not randomised, non-blinded single centre observation study on 40 volunteers between 18-75 years of age with an unspecific discomfort in the nose such as enhanced nasal discharge/ secretion (runny nose), congested nose, sneezing, itchy nose or feeling of a dry nose.', 'detailedDescription': 'By regularisation of environment of nasal mucosa and the following restitution and improvement of the ciliary function the efficacy of mucociliary clearance can be remarkably enhanced, pathogens from the environment can be physically removed and a bacterial or viral infection may be prevented on this way.\n\nSuch an optimizing effect may be reached by the administration of an equilibrated saline solution with an optimal composition regarding osmolality, pH-value and buffer substance.\n\nIn addition it would be very advantageous to support the efficacy of the local unspecific and specific immune mechanisms in the nasal respiratory mucosa (NALT) without any negative effects on the optimized mucociliary clearance.\n\nAs demonstrated recently in airway mucosa sodium propionate is able to interact with macrophages, the interleukin system and other factors of the TNF receptor family.\n\nSodium propionate could therefore have an ancillary effect on the genuine immune mechanisms of nasal respiratory mucosa. On this way the primary effect of administration of saline solution is supported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nKey inclusion criteria are one or more of the following symptoms:\n\n* nasal discharge/ secretion (runny nose)\n* congested nose\n* sneezing\n* itchy nose\n* feeling of a dry nose\n\nExclusion Criteria:\n\nKey exclusion criteria:\n\n* \\<18 years of age\n* 75 years of age'}, 'identificationModule': {'nctId': 'NCT03251066', 'briefTitle': 'Immediate Effect of Proponent-Nasal-Spray on Unspecific Discomfort in the Nose', 'organization': {'class': 'INDUSTRY', 'fullName': 'PRECLIN Biosystems AG'}, 'officialTitle': 'Open, Not Randomised, Non-blinded Observation Study to Investigate the Immediate Effect of Proponent - Nasal - Spray in Case of Unspecific Discomfort in the Nose', 'orgStudyIdInfo': {'id': 'PNSY2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Test group', 'description': 'Proponent Nasal Spray Medical device', 'interventionNames': ['Other: Proponent Nasal Spray']}], 'interventions': [{'name': 'Proponent Nasal Spray', 'type': 'OTHER', 'description': 'The medical device consists of a Saline solution containing sodium propionate which is administered as single dose', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie University Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Soyka Michael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ORL, USZ'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PRECLIN Biosystems AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}