Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-04 @ 10:47 AM
Study NCT ID:
NCT02646904
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2015-12-18', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasal patency evaluated by acoustic rhinometry.', 'timeFrame': '21 days', 'description': 'The main objective is to assess the increase of nasal patency in children aged 6-16 with perennial allergic rhinitis (PAR), treated with Beclometasone nasal spray 100 µg/die for 21 days.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of Beclometasone nasal spray on subjective nasal symptoms', 'timeFrame': '21 days', 'description': 'The secondary objective is to measure the impact of Beclometasone nasal spray 100 µg on subjective nasal symptoms, in children aged 6-16 with perennial allergic rhinitis (PAR), assessed by T4SS Questionnaire(Total 4 Symptoms Score).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children 6-16 years of age with a history of AR in the previous year\n* T5SS: ≥5 in the last week before enrollment\n\nExclusion Criteria:\n\n* asthma symptoms\n* acute upper respiratory infections\n* anatomic nasal defects (ie, septum deviation), or nasal polyps\n* use in the past 4 weeks of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines.'}, 'identificationModule': {'nctId': 'NCT02646904', 'briefTitle': 'Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': "Istituto per la Ricerca e l'Innovazione Biomedica"}, 'officialTitle': 'Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis', 'orgStudyIdInfo': {'id': '9-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beclometasone Dipropionate (BDP)', 'description': 'Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days.', 'interventionNames': ['Drug: Nasal Beclomethasone Dipropionate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CERCHIO 10 mg/ml OS', 'description': 'For Children \\< 12 years old 10 drops die (5 mg die) for 21 days. For Children \\> 12 years old 20 drops die (10 mg die) for 21 days.', 'interventionNames': ['Drug: CERCHIO 10 mg/ml OS']}], 'interventions': [{'name': 'Nasal Beclomethasone Dipropionate', 'type': 'DRUG', 'otherNames': ['NBDP'], 'description': 'Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days.', 'armGroupLabels': ['Beclometasone Dipropionate (BDP)']}, {'name': 'CERCHIO 10 mg/ml OS', 'type': 'DRUG', 'description': 'For Children \\< 12 years old 10 drops die (5 mg die) for 21 days. For Children \\> 12 years old 20 drops die (10 mg die) for 21 days.', 'armGroupLabels': ['CERCHIO 10 mg/ml OS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90146', 'city': 'Palermo', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Institute of Biomedicine and Molecular Immunology, IBIM', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The IPD collected will be available on February 2017.\n\nThe following participant data will be shared:\n\n* Nasal patency\n* Nasal symptom score\n* Demographic characteristics\n\nAll IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stefania La Grutta, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Senior Researcher, Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.', 'investigatorFullName': 'Stefania La Grutta, MD', 'investigatorAffiliation': "Istituto per la Ricerca e l'Innovazione Biomedica"}}}}