Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT02381158
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2015-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012135', 'term': 'Respiratory Sounds'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung fuction with Rint and FOT', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wheezing', 'Children'], 'conditions': ['Wheezing']}, 'descriptionModule': {'briefSummary': 'This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of symptoms and exacerbations, will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed and subscribed consent before any procedure\n* Age range : 2 - ≤5 years\n* Male and female patients\n* Recurrent wheezing affected ( ≥ 4 episodes in the last 12 months)\n* PAI positive (at least one primary and two secondary ):\n\nPrimary:\n\n1. one parent with asthma\n2. Atopic Dermatitis\n3. sensibilisation to air allergen\n\nSecondary:\n\n1. Food sensibilization\n2. wheezing also not during the infective episodes\n3. eosinophilia (\\>4%)\n\nExclusion Criteria:\n\n* story of severe wheeze requiring hospitalization\n* treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks\n* structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc)\n* Persistent infections\n* aspiration lung disease (gastroesophageal reflux disease, etc.)\n* Cystic fibrosis\n* prematurity or bronchopulmonary dysplasia\n* Tuberculosis\n* primary ciliary dyskinesia\n* congenital heart disease\n* pulmonary foreign body\n* bronchiectasis\n* Immunodeficit'}, 'identificationModule': {'nctId': 'NCT02381158', 'briefTitle': 'Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing', 'organization': {'class': 'OTHER', 'fullName': "Istituto per la Ricerca e l'Innovazione Biomedica"}, 'officialTitle': 'Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing', 'orgStudyIdInfo': {'id': '0000573'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebulized Beclomethasone dipropionate', 'description': 'Nebulized Beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg).', 'interventionNames': ['Drug: Nebulized beclomethasone dipropionate']}], 'interventions': [{'name': 'Nebulized beclomethasone dipropionate', 'type': 'DRUG', 'otherNames': ['BDP'], 'description': 'Nebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg)', 'armGroupLabels': ['Nebulized Beclomethasone dipropionate']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Istituto per la Ricerca e l'Innovazione Biomedica", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Stefania La Grutta, MD', 'investigatorAffiliation': "Istituto per la Ricerca e l'Innovazione Biomedica"}}}}