Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-29 @ 7:45 AM
Study NCT ID:
NCT00503659
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2007-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Methods of Bronchial Methacholine Provocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016535', 'term': 'Bronchial Hyperreactivity'}, {'id': 'D001249', 'term': 'Asthma'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-07', 'studyFirstSubmitDate': '2007-07-18', 'studyFirstSubmitQcDate': '2007-07-18', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation of the two parameters PC20 FEV1 and PD20 FEV1', 'timeFrame': 'feb 2007 - dec 2007'}], 'secondaryOutcomes': [{'measure': 'kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration', 'timeFrame': 'see above'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PC20 FEV1', 'PD20FEV1', 'bronchial hyperreactivity', 'bronchial asthma'], 'conditions': ['Bronchial Hyperreactivity', 'Bronchial Asthma']}, 'referencesModule': {'references': [{'pmid': '10619836', 'type': 'BACKGROUND', 'citation': 'Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study is meant to compare two routine diagnostic approaches in patients with bronchial asthma. Patients are challenged with methacholine in order to measure their bronchial response. We compare the evaluation of the effects of incremental concentrations versus incremental dosages.', 'detailedDescription': 'Bronchial methacholine challenge is well established in asthma diagnostic and research purposes. ATS guidelines provide a short five-breath dosimeter protocol using a five-step dilution schedule. The Viasys APS system enables a feasible and less time consuming provocation with incremental dosages. In 48 young adults with bronchial hyperreactivity (BHR) the ATS-protocol with a five-step protocol using a single dilution of 16 mg/ml methacholine should be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent\n* Age 12-45 years\n* Known bronchial hyperreactivity\n\nExclusion Criteria:\n\n* Age \\< 12 \\> 45 years\n* Clinical asthma requiring regular inhalation\n* Vital capacity \\< 80%\n* FEV1 \\< 75%\n* Chronic disease conditions or infections\n* Pregnancy\n* Inhalative or systemic steroid use\n* Substance abuse\n* Incapability of understanding the study's purpose and performance"}, 'identificationModule': {'nctId': 'NCT00503659', 'briefTitle': 'Comparison of Two Methods of Bronchial Methacholine Provocation', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1', 'orgStudyIdInfo': {'id': '335/06/FFM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Methacholine challenge, five-breath dosimeter protocol', 'interventionNames': ['Procedure: Bronchial methacholine provocation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Methacholine challenge five incremental dosages protocol', 'interventionNames': ['Procedure: Bronchial methacholine provocation']}], 'interventions': [{'name': 'Bronchial methacholine provocation', 'type': 'PROCEDURE', 'otherNames': ['DeVilbiss nebulizer'], 'description': 'A short five-breath dosimeter protocol using a five-step dilution schedule according to ATS guidelines (0.0625, 0.25, 1, 4, 16 mg/ml methacholine)', 'armGroupLabels': ['A']}, {'name': 'Bronchial methacholine provocation', 'type': 'PROCEDURE', 'otherNames': ['Viasys APS nebulizer'], 'description': 'A five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg)', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University, Department of Pulmonology', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Stefan Zielen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University, Department of Pulmonology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Pediatric Allergy and Pulmonológy', 'investigatorFullName': 'Johannes Schulze MD', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}