Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-09 @ 4:44 AM
Study NCT ID:
NCT00550602
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2007-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracheobronchomalacia: Treatment Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055090', 'term': 'Tracheomalacia'}, {'id': 'D055089', 'term': 'Tracheobronchomalacia'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D002357', 'term': 'Cartilage Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014133', 'term': 'Tracheal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2007-10-26', 'studyFirstSubmitQcDate': '2007-10-26', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.', 'timeFrame': 'At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.', 'timeFrame': 'At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tracheomalacia', 'Tracheobronchomalacia', 'Airway Stabilization', 'Bronchoscopy', 'Stent Placement', 'Tracheobronchoplasty', 'COPD'], 'conditions': ['Tracheomalacia', 'Tracheobronchomalacia']}, 'referencesModule': {'references': [{'pmid': '17699133', 'type': 'RESULT', 'citation': "Ernst A, Majid A, Feller-Kopman D, Guerrero J, Boiselle P, Loring SH, O'Donnell C, Decamp M, Herth FJ, Gangadharan S, Ashiku S. Airway stabilization with silicone stents for treating adult tracheobronchomalacia: a prospective observational study. Chest. 2007 Aug;132(2):609-16. doi: 10.1378/chest.06-2708."}, {'pmid': '21868463', 'type': 'DERIVED', 'citation': 'Ernst A, Odell DD, Michaud G, Majid A, Herth FFJ, Gangadharan SP. Central airway stabilization for tracheobronchomalacia improves quality of life in patients with COPD. Chest. 2011 Nov;140(5):1162-1168. doi: 10.1378/chest.10-3051. Epub 2011 Aug 25.'}, {'pmid': '21493699', 'type': 'DERIVED', 'citation': 'Odell DD, Shah A, Gangadharan SP, Majid A, Michaud G, Herth F, Ernst A. Airway stenting and tracheobronchoplasty improve respiratory symptoms in Mounier-Kuhn syndrome. Chest. 2011 Oct;140(4):867-873. doi: 10.1378/chest.10-2010. Epub 2011 Apr 14.'}, {'pmid': '18842912', 'type': 'DERIVED', 'citation': 'Majid A, Guerrero J, Gangadharan S, Feller-Kopman D, Boiselle P, DeCamp M, Ashiku S, Michaud G, Herth F, Ernst A. Tracheobronchoplasty for severe tracheobronchomalacia: a prospective outcome analysis. Chest. 2008 Oct;134(4):801-807. doi: 10.1378/chest.08-0728.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).', 'detailedDescription': 'TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM.\n\nOur study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult population with suspected symptomatic tracheal and/or bronchial collapse referred to our institution by a Pulmonologist or Thoracic Surgeon.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspicion of symptomatic tracheal and/or bronchial collapse during bronchoscopy or Dynamic Computed Tomographic study.\n* Chronic Obstructive Pulmonary Disease (regardless of severity) and suspicion of tracheal and/or bronchial collapse\n\nExclusion Criteria:\n\n* inability to follow commands\n* Focal extrinsic compression of the trachea/bronchi by mass or other'}, 'identificationModule': {'nctId': 'NCT00550602', 'briefTitle': 'Tracheobronchomalacia: Treatment Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Tracheobronchomalacia: Treatment Outcomes', 'orgStudyIdInfo': {'id': '2005P000112'}}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Armin Ernst, M.D. FCCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Armin Ernst, MD', 'oldOrganization': 'BIDMC'}}}}