Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT00906867
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2009-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D064706', 'term': 'Vocal Cord Dysfunction'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, total IgE'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2009-05-20', 'studyFirstSubmitQcDate': '2009-05-20', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior.', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vocal cord dysfunction', 'Laryngoscopy', 'Methacholine challenge', 'Pulmonary function testing'], 'conditions': ['Dyspnea']}, 'referencesModule': {'references': [{'pmid': '12475837', 'type': 'BACKGROUND', 'citation': 'Perkins PJ, Morris MJ. Vocal cord dysfunction induced by methacholine challenge testing. Chest. 2002 Dec;122(6):1988-93. doi: 10.1378/chest.122.6.1988.'}, {'pmid': '16954978', 'type': 'BACKGROUND', 'citation': 'Guss J, Mirza N. Methacholine challenge testing in the diagnosis of paradoxical vocal fold motion. Laryngoscope. 2006 Sep;116(9):1558-61. doi: 10.1097/01.mlg.0000228007.74561.33.'}, {'pmid': '18182970', 'type': 'BACKGROUND', 'citation': 'Husein OF, Husein TN, Gardner R, Chiang T, Larson DG, Obert K, Thompson J, Trudeau MD, Dell DM, Forrest LA. Formal psychological testing in patients with paradoxical vocal fold dysfunction. Laryngoscope. 2008 Apr;118(4):740-7. doi: 10.1097/MLG.0b013e31815ed13a.'}, {'pmid': '15609638', 'type': 'BACKGROUND', 'citation': 'Sandage MJ, Zelazny SK. Paradoxical vocal fold motion in children and adolescents. Lang Speech Hear Serv Sch. 2004 Oct;35(4):353-62. doi: 10.1044/0161-1461(2004/034).'}, {'pmid': '8948611', 'type': 'BACKGROUND', 'citation': 'Loughlin CJ, Koufman JA. Paroxysmal laryngospasm secondary to gastroesophageal reflux. Laryngoscope. 1996 Dec;106(12 Pt 1):1502-5. doi: 10.1097/00005537-199612000-00011.'}, {'pmid': '7551399', 'type': 'BACKGROUND', 'citation': 'Newman KB, Mason UG 3rd, Schmaling KB. Clinical features of vocal cord dysfunction. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1382-6. doi: 10.1164/ajrccm.152.4.7551399.'}, {'pmid': '16598999', 'type': 'BACKGROUND', 'citation': 'Mikita CP, Mikita JA. Allergic bronchopulmonary aspergillosis. Allergy Asthma Proc. 2006 Jan-Feb;27(1):82-4.'}, {'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.'}, {'pmid': '7789502', 'type': 'BACKGROUND', 'citation': 'Asher MI, Keil U, Anderson HR, Beasley R, Crane J, Martinez F, Mitchell EA, Pearce N, Sibbald B, Stewart AW, et al. International Study of Asthma and Allergies in Childhood (ISAAC): rationale and methods. Eur Respir J. 1995 Mar;8(3):483-91. doi: 10.1183/09031936.95.08030483.'}]}, 'descriptionModule': {'briefSummary': "Vocal cord dysfunction is a rare clinical picture. It is labeled as a sudden and threatening dyspnea. Patients with VCD may also present cough, hoarseness, wheezing, and chest tightness, but an inspiratory stridor is the most common symptom. For this reason, such patients are often misdiagnosed with refractory asthma, because of poor response to steroids and bronchodilators. Diagnosis is suspected on clinical grounds and is confirmed with laryngoscopy. The therapy consists of education, speech therapy and if necessary psychotherapy. The purpose of the investigators' study is to characterize children, adolescents, and young adults with VCD, and the evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric features.", 'detailedDescription': 'VCD appears to be significantly more common among females. The episode of dyspnea underlies the paradoxical, intermittent adduction of the vocal cords during inspiration. Methacholine challenge testing combined with laryngoscopy is useful in differentiating vocal cord dysfunction from asthma during the asymptomatic period.\n\nIn one visit patients will be characterized with a questionnaire based on the ISAAC questionnaire. Furthermore, FeNO, eCO, skin prick testing and total serum IgE will be examined. The psychiatric condition of patients will be determined by CBCL/6-18 and YSR/11-18 behavior questionnaires. After initial fiberoptic laryngoscopy and pulmonary function testing, bronchoprovocation is performed using nebulized methacholine at increasing doses, until a 20% decline in the forced expiratory volume in 1 second is achieved (PD20FEV1). Each methacholine testing will be followed by a second laryngoscopy and pulmonary function testing. The visualization of paradoxical vocal cord motion during inspiration will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients of departement of Pediatric Pulmonology and Allergology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Age 7 to 30 Years\n* Documented VCD or strong suspicion of VCD\n* Pulmonary function test: FEV1 (% pred.) ≥ 70%\n\nExclusion Criteria:\n\n* Age \\< 7 and \\> 30 Years\n* Pulmonary function test: FEV1 (% pred.) \\< 70%\n* Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)\n* Pregnancy\n* Documented alcohol, substance, and/or drug abuse\n* Incapability to perform all study procedure\n* Current participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT00906867', 'acronym': 'VCD', 'briefTitle': 'Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)', 'orgStudyIdInfo': {'id': 'KGU-62/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vocal cord dysfunction', 'description': 'Patients with suspicion of VCD', 'interventionNames': ['Other: Methacholine challenge testing', 'Procedure: Rhino-laryngoscopy']}], 'interventions': [{'name': 'Methacholine challenge testing', 'type': 'OTHER', 'otherNames': ['Aerosol Provocation System (Cardinal Health GmbH)'], 'description': 'Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg', 'armGroupLabels': ['Vocal cord dysfunction']}, {'name': 'Rhino-laryngoscopy', 'type': 'PROCEDURE', 'otherNames': ['ENF-V2 laryngoscope Olympus'], 'description': 'Topical anesthesia (Xylocain Pump spray) followed by transnasal fiberoptic laryngoscopy with a flexible fiberoptic laryngoscope.', 'armGroupLabels': ['Vocal cord dysfunction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60596', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Goethe University Hospital', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Stefan Zielen, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University, Frankfurt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cosultant Pediatric Allergy and Pulmonolgy', 'investigatorFullName': 'Johannes Schulze MD', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}