Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-02 @ 10:35 PM
Study NCT ID:
NCT04230993
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2020-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of nasal washing with a hypertonic seawater solution Nose hygiene).', 'timeFrame': '3 days', 'description': 'Effect of nasal washing with a hypertonic seawater solution (Ocean Bio Actif-Fluid + or Ocean Bio Actif-Stuffy nose) on runny nose and nasal congestion during treatment after 3 days of use, compared to an isotonic solution (Ocean Bio Actif- Nose hygiene). symptom score (runny nose and nasal congestion) derived from the Jackson scale with a score of 0 to 3 for each (0: absent; 1: mild; 2: moderate; 3: severe) between Day 0 and Day 3.'}], 'secondaryOutcomes': [{'measure': 'Symptom score', 'timeFrame': '7 days', 'description': 'The effect of nasal wash on the evolution of symptoms over time'}, {'measure': 'Presence or absence of fluid mucus', 'timeFrame': '7 days', 'description': 'The effect of nasal wash on the evolution of the mucus fluidification over time'}, {'measure': 'Global Clinical Impression Scale', 'timeFrame': 'between day 3 and day 7', 'description': 'Global Clinical Impression of the investigator on the evolution of symptoms'}, {'measure': 'Global Patient Impression Scale', 'timeFrame': 'between day 3 and day 7', 'description': 'Global Impression of the patient on the evolution of symptoms'}, {'measure': 'Use of medical device', 'timeFrame': '7 days', 'description': 'Number of daily sprays'}, {'measure': 'Safety of medical device', 'timeFrame': '7 days', 'description': 'Number of adverse events'}, {'measure': 'Likert scale', 'timeFrame': '7 days', 'description': 'Satisfaction of patient for the medical device'}, {'measure': 'Number of concomitant treatment', 'timeFrame': '7 days', 'description': 'concomitant administration of treatments related to rhinitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhinitis']}, 'descriptionModule': {'briefSummary': 'The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.', 'detailedDescription': 'The main endpoint is a symptom score derived from the Jackson scale: sum of 2 items relating to runny nose and nasal congestion (stuffy nose), with ratings of 0 to 3 for each (0: absent ; 1: mild; 2: moderate; 3: severe).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person with an upper respiratory condition (cold, rhinitis, nasopharyngitis ...) with symptoms of nasal congestion and intense runny nose moderate to severe (Jackson derived score ≥ 4)\n* Ability of the patient (for adults) or their legal representative (for children) to follow the guidelines of the medical device\n* have given their written informed consent\n\nExclusion Criteria:\n\n* Patient with no cold symptoms, including no nasal congestion (chronic dry rhinitis…)\n* Patient under treatment with cortisone derivative, mucolytic, or medication containing pseudoephedrine or related product acting on nasal congestion or having used such a product in the 3 days before inclusion\n* Patient who used a nasal wash product in the 3 days before inclusion\n* Patient allergic to seafood, or to any of the components of the products under study\n* Vulnerable patient whose inclusion is not justified by the research objectives: woman pregnant, parturient, psychiatric patient, or adult subject to legal protection\n* Patient participating or having participated in any other clinical study in the 30 days before the study.'}, 'identificationModule': {'nctId': 'NCT04230993', 'acronym': 'DEFI', 'briefTitle': 'Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification', 'organization': {'class': 'INDUSTRY', 'fullName': 'YSLab'}, 'officialTitle': 'Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification', 'orgStudyIdInfo': {'id': '2019-A01705-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ocean Bio Actif-Fluid+', 'description': 'Moderate hypertonic seawater solution (15 g / L NaCl) with polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.', 'interventionNames': ['Other: Sea water solution']}, {'type': 'EXPERIMENTAL', 'label': 'Ocean Bio Active-Stuffy nose', 'description': 'Moderate hypertonic seawater solution (15 g / L NaCl) without polysorbate 80. The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.', 'interventionNames': ['Other: Sea water solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ocean Bio Active-Hygiene of the nose', 'description': 'Isotonic seawater solution (9 g / L NaCl). The use is 1 to 2 sprays per nostril 4 times a day until symptoms of cold disappear, according to the instructions for use of the products.', 'interventionNames': ['Other: Sea water solution']}], 'interventions': [{'name': 'Sea water solution', 'type': 'OTHER', 'description': 'Administration of different sea water solution is performed and the rating of cold symptoms according to the Jackson scale, the fluidity of mucus and the ease of blowing will be evaluated.', 'armGroupLabels': ['Ocean Bio Actif-Fluid+', 'Ocean Bio Active-Hygiene of the nose', 'Ocean Bio Active-Stuffy nose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oignies', 'country': 'France', 'facility': 'Medical office', 'geoPoint': {'lat': 50.46331, 'lon': 2.99376}}], 'overallOfficials': [{'name': 'Alain BOYE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coordinator of the study'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'YSLab', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}