Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-01 @ 5:58 PM
Study NCT ID:
NCT06393257
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Airway Clearance Technique of Oscillation and Lung Expansion 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015916', 'term': 'Drainage, Postural'}, {'id': 'D005100', 'term': 'Expectorants'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D019141', 'term': 'Respiratory System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into one of the two groups. No cross-over of the study group will be made'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-27', 'studyFirstSubmitDate': '2024-04-21', 'studyFirstSubmitQcDate': '2024-04-27', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sputum volume in 24h', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Bronchiectasis exacerbation and symptom tool', 'timeFrame': 'Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge', 'description': 'BEST score'}, {'measure': 'Quality of life questionnaire-bronchiectasis', 'timeFrame': 'Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge', 'description': 'Qol-B score'}, {'measure': 'Leicester Cough Questionnaire', 'timeFrame': 'Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge', 'description': 'LCQ score'}, {'measure': 'Bronchiectasis Health Questionnaire', 'timeFrame': 'Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge', 'description': 'BHQ score'}, {'measure': 'Time to the first bronchiectasis exacerbation since randomization', 'timeFrame': 'Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge', 'description': 'Time to the first bronchiectasis exacerbation since randomization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchiectasis', 'Airway Clearance Technique'], 'conditions': ['Bronchiectasis Adult']}, 'referencesModule': {'references': [{'pmid': '23945301', 'type': 'BACKGROUND', 'citation': 'Zhou YM, Wang C, Yao WZ, Chen P, Kang J, Huang SG, Chen BY, Wang CZ, Ni DT, Liu SM, Wang XP, Wang DL, Lu JC, Zheng JP, Zhong NS, Ran PX. [The prevalence and risk factors of bronchiectasis in residents aged 40 years old and above in seven cities in China]. Zhonghua Nei Ke Za Zhi. 2013 May;52(5):379-82. Chinese.'}, {'pmid': '26882271', 'type': 'BACKGROUND', 'citation': 'Lin JL, Xu JF, Qu JM. Bronchiectasis in China. Ann Am Thorac Soc. 2016 May;13(5):609-16. doi: 10.1513/AnnalsATS.201511-740PS.'}, {'pmid': '32622820', 'type': 'BACKGROUND', 'citation': "Basavaraj A, Choate R, Addrizzo-Harris D, Aksamit TR, Barker A, Daley CL, Anne Daniels ML, Eden E, DiMango A, Fennelly K, Griffith DE, Johnson MM, Knowles MR, Metersky ML, Noone PG, O'Donnell AE, Olivier KN, Salathe MA, Schmid A, Thomashow B, Tino G, Winthrop KL. Airway Clearance Techniques in Bronchiectasis: Analysis From the United States Bronchiectasis and Non-TB Mycobacteria Research Registry. Chest. 2020 Oct;158(4):1376-1384. doi: 10.1016/j.chest.2020.06.050. Epub 2020 Jul 3."}, {'pmid': '29326318', 'type': 'BACKGROUND', 'citation': 'Munoz G, de Gracia J, Buxo M, Alvarez A, Vendrell M. Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701926. doi: 10.1183/13993003.01926-2017. Print 2018 Jan.'}, {'pmid': '28952156', 'type': 'BACKGROUND', 'citation': 'Lee AL, Burge AT, Holland AE. Positive expiratory pressure therapy versus other airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2017 Sep 27;9(9):CD011699. doi: 10.1002/14651858.CD011699.pub2.'}, {'pmid': '34537448', 'type': 'BACKGROUND', 'citation': 'Liu Y, Lu HW, Gu SY, Wang WW, Ge J, Jie ZJ, Jia JG, Gao ZT, Li J, Shi JY, Liang S, Cheng KB, Bai JW, Qu JM, Xu JF. Bronchoscopic airway clearance therapy for acute exacerbations of bronchiectasis. EBioMedicine. 2021 Oct;72:103587. doi: 10.1016/j.ebiom.2021.103587. Epub 2021 Sep 16.'}, {'pmid': '31362061', 'type': 'BACKGROUND', 'citation': 'Huynh TT, Liesching TN, Cereda M, Lei Y, Frazer MJ, Nahouraii MR, Diette GB. Efficacy of Oscillation and Lung Expansion in Reducing Postoperative Pulmonary Complication. J Am Coll Surg. 2019 Nov;229(5):458-466.e1. doi: 10.1016/j.jamcollsurg.2019.06.004. Epub 2019 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this prospective randomized controlled trial is to explore the efficacy and safety of Oscillation and Lung Expansion-a airway clearance technology-in bronchiectasis. Participants will receive Oscillation and Lung Expansion or postural drainage randomly in this study. and the symptom, quality of life scores and amount of expectoration will be compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with acute exacerbation of bronchiectasis\n\nExclusion Criteria:\n\n* Haemoptysis greater than 50ml\n* state of endangerment\n* pneumothorax\n* Lung surgery history within 6 months\n* Severe heart, brain and nervous system diseases'}, 'identificationModule': {'nctId': 'NCT06393257', 'briefTitle': 'Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pulmonary Hospital, Shanghai, China'}, 'officialTitle': 'Efficacy and Safety of Airway Clearance Technique by Oscillation and Lung Expansion in Patients With Bronchiectasis', 'orgStudyIdInfo': {'id': '20230901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oscillation and Lung Expansion', 'interventionNames': ['Device: Oscillation and Lung Expansion', 'Drug: Anti-infective therapy', 'Drug: Mucolytic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'postural drainage', 'interventionNames': ['Behavioral: Postural drainage', 'Drug: Anti-infective therapy', 'Drug: Mucolytic']}], 'interventions': [{'name': 'Oscillation and Lung Expansion', 'type': 'DEVICE', 'description': 'A novel airway clearance technology', 'armGroupLabels': ['Oscillation and Lung Expansion']}, {'name': 'Postural drainage', 'type': 'BEHAVIORAL', 'description': "A type of physical therapy used to treat respiratory diseases by changing the patient's body position so that sputum is drained down the respiratory tract so that it can be more easily expelled from the body.", 'armGroupLabels': ['postural drainage']}, {'name': 'Anti-infective therapy', 'type': 'DRUG', 'description': 'Antibiotics were used in these patients.', 'armGroupLabels': ['Oscillation and Lung Expansion', 'postural drainage']}, {'name': 'Mucolytic', 'type': 'DRUG', 'description': 'Mucolytics were used in these patients.', 'armGroupLabels': ['Oscillation and Lung Expansion', 'postural drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie-ming Qu, PhD', 'role': 'CONTACT'}, {'name': 'Jie-ming Qu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin-Fu Xu, PhD', 'role': 'CONTACT', 'email': 'jfxucn@163.com', 'phone': '+8613321922898'}], 'facility': 'Shanghai pulmonary hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Zhang, MD', 'role': 'CONTACT'}, {'name': 'Min Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jin-Fu Xu, PhD', 'role': 'CONTACT', 'email': 'jfxucn@163.com', 'phone': '+8613321922898'}], 'overallOfficials': [{'name': 'Jin-Fu Xu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Pulmonary Hospital, Shanghai, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Fu Xu', 'investigatorAffiliation': 'Shanghai Pulmonary Hospital, Shanghai, China'}}}}