Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-29 @ 12:42 PM
Study NCT ID:
NCT05819203
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BАbykids Spray In Common Cold
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bgout@pharmndev.ch', 'phone': '+41798659000', 'title': 'Dr Bernard Gout', 'organization': 'Pharmndev Experts'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'In the absence of validated questionnaire assessing the severity and functional impact of an acute infectious rhinitis in young children, we used a customized non validated questionnaire, the ARSSQ (Acute Rhinitis Symptoms Severity Questionnaire).'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the intervention through the study completion , up to day 18', 'description': 'Reporting of adverse events and of incidents (Incident: any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect).', 'eventGroups': [{'id': 'EG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 11, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 14, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Scarlet fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'inner ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'epistaxis', 'notes': 'Adverse possibly related to the investigational device, ie incident reported to the competent authority per regulation EU 745/2017 , not rated as serious and did not lead to study /device discontinuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'pruritus', 'notes': 'Adverse possibly related to the investigational device, ie incident reported to the competent authority per regulation EU 745/2017 , not rated as serious and did not lead to study /device discontinuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash', 'notes': 'Adverse possibly related to the investigational device, ie incident reported to the competent authority per regulation EU 745/2017 , not rated as serious and did not lead to study /device discontinuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Full Analysis Set (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '78.1', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '93.6', 'spread': '28.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0013', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 10', 'description': 'ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening.\n\nThe minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).', 'unitOfMeasure': 'score on a scale*day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: all the subjects from the Safety Population and with at least one post-baseline efficacy data'}, {'type': 'SECONDARY', 'title': 'Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '6.92', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '7.61', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0209', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of the mean duration of common cold during the study between both groups.', 'statisticalMethod': 'Cox survival regression and p Wald', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, up to Day 18', 'description': 'For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days.\n\nDuration may be censored at Visit 2.', 'unitOfMeasure': 'Number of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '6.46', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '7.03', 'spread': '1.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0399', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of the mean duration of impact of common cold on quality of life during the study between both groups.', 'statisticalMethod': 'Cox survival regression and p Wald', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, up to Day 18', 'description': 'For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days.\n\nDuration may be censored at Visit 2.', 'unitOfMeasure': 'Duration in Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Days of Concomitant Treatments Use That May Affect Common Cold Symptoms (Antibiotics, Antipyretics, Systemic or Local Mucolytics, Decongestants, Antitussives, Systemic and Topical Corticosteroids)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '317', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, up to Day 18', 'description': 'Concomitant treatments use (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.', 'unitOfMeasure': 'number of days', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Days of Antibiotics Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000'], 'pValueComment': 'not significant', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion , up to day 18', 'description': 'Antibiotics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.', 'unitOfMeasure': 'number of days', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Days of Antipyretics Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, up to day 18', 'description': 'Antipyretics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.', 'unitOfMeasure': 'number of days', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Days of Mucolytics Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion , up to day 18', 'description': 'Mucolytics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.', 'unitOfMeasure': 'number of days', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Days of Decongestants Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0513', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, up to day 18', 'description': 'Decongestants use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.', 'unitOfMeasure': 'number of days', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Days of Antitussives Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0789', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, up to day 18', 'description': 'Antitussives use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.', 'unitOfMeasure': 'number of days', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Days of Systemic and Topical Corticosteroids Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, up to day 18', 'description': 'Systemic and topical corticosteroids use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.', 'unitOfMeasure': 'number of days', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'PRIMARY', 'title': 'The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Per Protocol Set (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'classes': [{'categories': [{'measurements': [{'value': '80.5', 'spread': '28.2', 'groupId': 'OG000'}, {'value': '96', 'spread': '29.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0034', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.'}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 10', 'description': 'ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening.\n\nThe minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).', 'unitOfMeasure': 'score on a scale*day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP: efficacy population based on the FAS for subjects without major protocol deviation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nHealsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).\n\nPlacebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '4.0', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '4.0', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-02', 'size': 1118740, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-03T09:36', 'hasProtocol': True}, {'date': '2023-08-09', 'size': 988801, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-03T04:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigational device and the comparator were indistinguishable. The comparator (isotonic nasal spray) used the same technology and the same packaging than Healsea Babykids. A white label with regulatory mentions for clinical investigations was stuck on the vial A white label with regulatory mentions was sticked on a white cardboard box used as secondary packaging. The IFUs (Bulgarian version) was included in the secondary packaging (on one face, Healsea Babykids, on the other face Placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial double blind'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2023-03-09', 'resultsFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-04', 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Full Analysis Set (FAS)', 'timeFrame': 'From Day 1 to Day 10', 'description': 'ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening.\n\nThe minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).'}, {'measure': 'The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Per Protocol Set (PP)', 'timeFrame': 'From Day 1 to Day 10', 'description': 'ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening.\n\nThe minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).'}], 'secondaryOutcomes': [{'measure': 'Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups', 'timeFrame': 'Through study completion, up to Day 18', 'description': 'For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days.\n\nDuration may be censored at Visit 2.'}, {'measure': 'Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ).', 'timeFrame': 'Through study completion, up to Day 18', 'description': 'For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days.\n\nDuration may be censored at Visit 2.'}, {'measure': 'Cumulative Number of Days of Concomitant Treatments Use That May Affect Common Cold Symptoms (Antibiotics, Antipyretics, Systemic or Local Mucolytics, Decongestants, Antitussives, Systemic and Topical Corticosteroids)', 'timeFrame': 'Through study completion, up to Day 18', 'description': 'Concomitant treatments use (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.'}, {'measure': 'Cumulative Number of Days of Antibiotics Intake', 'timeFrame': 'through study completion , up to day 18', 'description': 'Antibiotics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.'}, {'measure': 'Cumulative Number of Days of Antipyretics Intake', 'timeFrame': 'through study completion, up to day 18', 'description': 'Antipyretics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.'}, {'measure': 'Cumulative Number of Days of Mucolytics Intake', 'timeFrame': 'Through study completion , up to day 18', 'description': 'Mucolytics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.'}, {'measure': 'Cumulative Number of Days of Decongestants Use', 'timeFrame': 'through study completion, up to day 18', 'description': 'Decongestants use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.'}, {'measure': 'Cumulative Number of Days of Antitussives Use', 'timeFrame': 'through study completion, up to day 18', 'description': 'Antitussives use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.'}, {'measure': 'Cumulative Number of Days of Systemic and Topical Corticosteroids Use', 'timeFrame': 'Through study completion, up to day 18', 'description': 'Systemic and topical corticosteroids use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasal spray', 'supplemented isotonic saline solution', 'infectious rhinitis', 'children'], 'conditions': ['Common Cold', 'Rhinitis Viral']}, 'referencesModule': {'references': [{'pmid': '24415465', 'type': 'RESULT', 'citation': 'Passioti M, Maggina P, Megremis S, Papadopoulos NG. The common cold: potential for future prevention or cure. Curr Allergy Asthma Rep. 2014 Feb;14(2):413. doi: 10.1007/s11882-013-0413-5.'}, {'pmid': '32077450', 'type': 'RESULT', 'citation': "Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600."}, {'pmid': '12517470', 'type': 'RESULT', 'citation': 'Heikkinen T, Jarvinen A. The common cold. Lancet. 2003 Jan 4;361(9351):51-9. doi: 10.1016/S0140-6736(03)12162-9.'}, {'pmid': '28492494', 'type': 'RESULT', 'citation': 'Principi N, Esposito S. Nasal Irrigation: An Imprecisely Defined Medical Procedure. Int J Environ Res Public Health. 2017 May 11;14(5):516. doi: 10.3390/ijerph14050516.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this post market clinical investigation is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo in children above 2 years.', 'detailedDescription': 'Healsea® Babykids is an isotonic saline solution based nasal spray supplemented with a natural Symbiofilm® extract (0.04%) isolated from marine bacteria. Symbiofilm® has in vitro antibiofilm activity and protects in vitro human nasal epithelial cells viability after Rhinovirus, Adenovirus, coronavirus OC43 and flu infection.\n\nHealsea® Babykids is a nasal spray indicated in children above 2 years to clean and moisten the nose during colds and rhinitis.\n\nThe common cold is an acute viral infection of the upper respiratory tract, involving, to variable degrees, sneezing, nasal congestion and discharge (rhinorrhea), sore throat, cough, low-grade fever, headache, and malaise. Acute viral rhinitis is generally self-limiting. In children where the illness is not self-limiting and extends beyond 7-10 days, many agree that a bacterial infection is likely. Bacterial over infections and progression to a chronic state are favoured by the formation of biofilms, which facilitate bacterial growth and persistence as well as reducing antibiotic efficacy.\n\nThe aim of this study is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo.\n\nThe study comprises 2 parts:\n\n\\- Part 1 (Day 1-Day 11): treatment of the acute phase\n\n• with Healsea® Babykids, 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Healsea® Babykids) up to 10 days (20 intakes of the investigational device).\n\nor • with isotonic nasal spray (Placebo), 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Placebo) up to 10 days (20 intakes of the investigational device).\n\n\\- Part 2 (up to Day 15/Day 18): follow-up phase.\n\nThe study comprises two visits:\n\n* Visit 1 (V1) at Day 1\n* End of study visit (Visit 2, V2) between Day 15 and Day 18'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '25 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Male/Female subjects \\>2 and ≤6-year-old\n* 2\\. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry\n* 3\\. Patient presenting with fever ≥ 37.5 °C at screening\n* 4\\. Subjects with nasal congestion (blocked / stuffy nose) rated at least as moderate on the Acute Rhinitis Symptoms Severity Questionnaire, based on evaluation by the investigator\n* 5\\. Subjects showing at least moderate grade for at least one of the following additional signs of acute rhinitis: runny nose, nasal crust (dry mucus), sneezing and cough\n* 6\\. Written consent obtained from parent/legal guardians\n\nExclusion Criteria:\n\n* 1\\. Known hypersensitivity/allergy to any component of the test device\n* 2\\. Medical history that is considered by the investigator as a reason for non-inclusion,\n* 3\\. Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps\n* 4\\. History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores\n* 5\\. Antibiotic intake within 2 weeks before screening\n* 6\\. Systemic corticosteroids within 4 weeks before screening\n* 7\\. Chronic decongestant use\n* 8\\. Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence ARSSQ score at screening (NSAID, nasal decongestants, cough medicines)'}, 'identificationModule': {'nctId': 'NCT05819203', 'acronym': 'BASICC', 'briefTitle': 'BАbykids Spray In Common Cold', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lallemand Pharma AG'}, 'officialTitle': 'Efficacy and Safety of Healsea® Babykids in the Treatment of Acute Infectious Rhinitis Symptoms in Children', 'orgStudyIdInfo': {'id': 'LPH-2202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healsea Babykids', 'description': 'Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).', 'interventionNames': ['Device: Healsea Babykids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa.\n\nSubjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Healsea Babykids', 'type': 'DEVICE', 'description': '7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .', 'armGroupLabels': ['Healsea Babykids']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': '7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Medical center', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical center', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Vratsa', 'country': 'Bulgaria', 'facility': 'Medical center', 'geoPoint': {'lat': 43.21052, 'lon': 23.56312}}], 'overallOfficials': [{'name': 'Rada MARKOVA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Center, Sofia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lallemand Pharma AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}