Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT00550758
Status:
TERMINATED
Last Update Posted:
2007-10-30
First Post:
2007-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003371', 'term': 'Cough'}], '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': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'whyStopped': 'the study has recently ended, all information gathred as planed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-29', 'studyFirstSubmitDate': '2007-10-20', 'studyFirstSubmitQcDate': '2007-10-29', 'lastUpdatePostDateStruct': {'date': '2007-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of a Fall of 20% FEV1 from baseline values (PC20FEV1)', 'timeFrame': 'after intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Methacholine challenge; Spirometry, Early childhood'], 'conditions': ['Asthma', 'Recurrent Cough']}, 'descriptionModule': {'briefSummary': 'Rational: The possible contribution of methacholine challenge test via spirometry to the clinical diagnosis of young children with various respiratory symptoms, the most appropriate spirometry index, and the proper cutoff point concentration that will define airway sensitivity have not yet been explored. Objectives: To assess airway reactivity by spirometry in a large group of children aged 3-6years with various respiratory symptoms.', 'detailedDescription': "We aimed to gather information concerning methacholine challenge test performed in children previously diagnosed with asthma (asthmatics) and 48 had prolonged cough (coughers) from the pediatric clinic at Meyer Children's Hospital.\n\nTests were performed by inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine).\n\nSpirometry was determined at baseline and after each inhalation in duplicate sets. End of test was defined by a fall of 20%FEV1 baseline (PC20-FEV1). PC20-FEV1\\<4.0mg/ml was considered positive). Results from the challenge were related to data from questionnaires concerning respiratory symptoms were analyzed at the end of the studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 3- to 6-years\n* respiratory diseases who were highly indicative of asthma diagnosis according to GINA guidelines \\[9\\]\n* cough duration of more than 4 weeks\n* normal chest auscultation and baseline FEV1\\>75% predicted for healthy preschool children, on the day of testing.\n\nExclusion Criteria:\n\n* presence of other chronic respiratory conditions\n* emergency room visit or the presence of respiratory infection within the last month\n* oral or inhaled steroids or other anti-inflammatory medication taken in the last two weeks\n* bronchodilator taken within 24-hours prior to the test.'}, 'identificationModule': {'nctId': 'NCT00550758', 'acronym': 'MCH-preschool', 'briefTitle': 'Spirometry and Methacholine Challenge Test in Asthmatic Children Age 3-6years', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Effect of Singular (Montelukast) 4mg on Hypersensitivity of the Airways in Children 3-5 Years Old. + Extended Study Hyprsensitivity of the Airways in Asthmatic Children Age 3-6years', 'orgStudyIdInfo': {'id': 'McH-Spir- preschool_CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Methachoine', 'type': 'DRUG', 'description': 'inhalation of triple-concentration increments (0.06 to13.9mg/ml/methacholine)'}, {'name': 'spirometry', 'type': 'DEVICE', 'description': 'spirometry'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lea Bentur, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rambam Health Care Campus'}, {'name': 'Daphna Vilozni, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}}}}