Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT05068518
Status:
UNKNOWN
Last Update Posted:
2021-10-06
First Post:
2021-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Airway Microbiota on Clinical Phenotypes and Disease Severity in Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2021-09-28', 'studyFirstSubmitQcDate': '2021-09-28', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute exacerbation', 'timeFrame': 'one year', 'description': 'visit ER or hsopitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchiectasis'], 'conditions': ['Bronchiectasis Adult']}, 'descriptionModule': {'briefSummary': 'Bronchiectasis is characterized pathologically by permanent bronchial dilatation and airway inflammation. The pathogenesis of the disease and the inflammatory, infective and molecular drivers of disease progression are not fully understood. The concept of "treatable traits" was proposed as biomarker-directed approach, based on the recognition of clinical phenotype and endotypes, help to personalized treatment options. Airway microbiota, including bacteria, NTM and fungus, have important but different inflammatory process in bronchiectasis. Our study will provide a new concept that airway microbiota might involve in the airway and systemic inflammation, mucus hypersecretion, as well as the airway damage, remodeling, and frequent exacerbations in bronchiectasis, thus leading to the deterioration of disease severity.\n\nBronchiectasis remains a major cause of respiratory morbidity and treatment is generally only partly successful. Our study will give more clues about the mechanisms on the inflammatory pathway and the probably different response among patients with different isolated microbiota from airways.', 'detailedDescription': 'Bronchiectasis is characterized pathologically by permanent bronchial dilatation and airway inflammation, and clinically by productive cough, hemoptysis and periodic infectious exacerbations. The pathogenesis of the disease and the inflammatory, infective and molecular drivers of disease progression are not fully understood. Current available therapeutic options have shown only a modest impact on disease outcomes in randomized clinical trials. The concept of "treatable traits" was proposed as biomarker-directed approach, based on the recognition of clinical phenotype and endotypes, help to personalized treatment options. Potential treatable traits of airways disease into four broad categories: pulmonary, extra-pulmonary, etiological, and behavior and lifestyle treatable traits. Airway microbiota, including bacteria, NTM and fungus, have important but different inflammatory process in bronchiectasis. Our study will provide a new concept that airway microbiota might involve in the airway and systemic inflammation, mucus hypersecretion, as well as the airway damage, remodeling, and frequent exacerbations in bronchiectasis, thus leading to the deterioration of disease severity.\n\nBronchiectasis remains a major cause of respiratory morbidity and treatment is generally only partly successful. Our study will give more clues about the mechanisms by which the immunomodulatory medications (macrolides) on the inflammatory pathway and the probably different response among patients with different isolated microbiota from airways. Thus, our results will not only shed light on the airway microbiota inflammatory mechanisms responsible for disease severity, but also provide a new therapeutic direction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients (age ≥ 20 years old) with bronchiectasis were recruited from the Thoracic Outpatient Clinic of Chang Gung Memorial Hospital in Taiwan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria were as follows: bronchiectasis documented on chest HRCT, idiopathic etiology of bronchiectasis, chronic sputum production (daily sputum ≥ 10 ml), absence of other major pulmonary diagnoses, and steady state defined by the absence of change of symptoms noted by the patient over the past 3 weeks\n\nExclusion Criteria:\n\n* The exclusion criteria were as follows: bronchiectasis with defined etiology (i.e, post-tuberculosis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis), common variable immunodeficiency, and use of antibiotics within the last 3 weeks. Patients with hepatic failure, malignancy, or pregnancy were also excluded.'}, 'identificationModule': {'nctId': 'NCT05068518', 'briefTitle': 'The Role of Airway Microbiota on Clinical Phenotypes and Disease Severity in Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Role of Airway Microbiota on Clinical Phenotypes and Disease Severity in Bronchiectasis', 'orgStudyIdInfo': {'id': 'MOST 110-2635-B-182A-006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'contacts': [{'name': 'Horng-Chyuan Lin', 'role': 'CONTACT', 'email': 'Lin53424@gmail.com'}], 'facility': 'Department of Thoracic Medicine, Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Chun Yu Lin, MD', 'role': 'CONTACT', 'email': 'pitiful1984@gmail.com', 'phone': '886-3-3281200', 'phoneExt': '8467'}, {'name': 'Horng Chyuan Lin, MD', 'role': 'CONTACT', 'email': 'Lin53424@gmail.com', 'phone': '886-3-3281200', 'phoneExt': '8470'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Lin, Chun-Yu', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}