Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 7:36 PM
Study NCT ID:
NCT00952835
Status:
UNKNOWN
Last Update Posted:
2013-06-19
First Post:
2009-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2009-08-03', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis', 'timeFrame': 'Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'rhinitis', 'EIB', 'Exhaled Nitric oxide', 'lung function', 'vitamin d'], 'conditions': ['Asthma', 'Rhinitis']}, 'referencesModule': {'references': [{'pmid': '22805466', 'type': 'DERIVED', 'citation': 'Chinellato I, Piazza M, Peroni D, Sandri M, Chiorazzo F, Boner AL, Piacentini G. Bronchial and alveolar nitric oxide in exercise-induced bronchoconstriction in asthmatic children. Clin Exp Allergy. 2012 Aug;42(8):1190-6. doi: 10.1111/j.1365-2222.2012.03973.x.'}, {'pmid': '22801008', 'type': 'DERIVED', 'citation': 'Peroni DG, Cattazzo E, Chinellato I, Piazza M, Tezza G, Boner AL, Piacentini GL. Nasal mucosa temperature as a marker of disease in children with allergic rhinitis. Am J Rhinol Allergy. 2012 Jul-Aug;26(4):e115-8. doi: 10.2500/ajra.2012.26.3803.'}]}, 'descriptionModule': {'briefSummary': 'In this study will be consecutive enrolled children with asthma (classified according to GINA guidelines) and rhinitis (classified by ARIA guidelines); the investigators will research clinical personal and parental history regarding allergic diseases, exposition to passive smoking and interpretate hematochemical parameters markers of atopy. Skin Prick Tests will be performed. In this study the investigators will evaluate lung function parameters (spirometry with bronchial reversibility test and exercise induced bronchoconstriction, oscillometry, respiratory plethysmography, etc.), airway inflammatory indices such as exhaled nitric oxide at different flows, exhaled and nasal temperature, nasal cytology.\n\nThe aim of the study will be to evaluate possible correlation between these different parameters and clinical status of the patients.', 'detailedDescription': 'Each patients will be evaluated by spirometry and then he will undergo exercise challenge in order to evaluate exercise-induced bronchoconstriction as a marker of asthma control. The test of the challenge will be correlate with childhood Asthma control test score,levels of control (GINA classification)and the different markers of airway inflammation and atopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'children with asthma and/or rhinitis visited at the outpatients clinic at the University of Verona will be invited to participate to the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with asthma and rhinitis\n\nExclusion Criteria:\n\n* age \\<5 years\n* chronic respiratory diseases'}, 'identificationModule': {'nctId': 'NCT00952835', 'briefTitle': 'Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Universita di Verona'}, 'officialTitle': 'Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis', 'orgStudyIdInfo': {'id': 'AOV-1716'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'asthma and rhinitis control', 'interventionNames': ['Other: regular treatment']}], 'interventions': [{'name': 'regular treatment', 'type': 'OTHER', 'otherNames': ['asthma treatment'], 'description': 'regular treatment', 'armGroupLabels': ['asthma and rhinitis control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37134', 'city': 'Verona', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Attilio Boner, MD', 'role': 'CONTACT', 'email': 'attilio.boner@univr.it', 'phone': '--390458124615'}, {'name': 'Attilio Boner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Iolanda Chinellato, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pediatric department University of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Attilio Boner, MD', 'role': 'CONTACT', 'email': 'attilio.boner@univr.it', 'phone': '--390458124615'}], 'overallOfficials': [{'name': 'Attilio Boner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita di Verona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita di Verona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera Universitaria Policlinico', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'full professor', 'investigatorFullName': 'Boner Attilio', 'investigatorAffiliation': 'Universita di Verona'}}}}