Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-29 @ 1:55 PM
Study NCT ID:
NCT07037303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Active Cycle of Breathing Techniques (ACBT) and Aerobika in Treating Bronchiectasis in Korea
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-22', 'size': 139939, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-03T02:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-21', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-21', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Acute Exacerbations in Patients with Bronchiectasis', 'timeFrame': '12 months from baseline', 'description': 'Number of acute exacerbations experienced by patients diagnosed with bronchiectasis during the 12-month study period.'}], 'secondaryOutcomes': [{'measure': 'Improvement in subjective symptoms (1)', 'timeFrame': 'Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline', 'description': "Evaluation of reductions from baseline in patients' self-reported symptoms (using Modified Medical Research Council (mMRC) dyspnea scale score) assessed at 1, 3, 6, 9, and 12 months (range: 0-4; higher scores indicate worse dyspnea)"}, {'measure': 'Improvement in subjective symptoms (2)', 'timeFrame': 'Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline', 'description': "Evaluation of changes from baseline in patients' self-reported symptoms (using Bronchiectasis Health Questionnaire (BHQ) score) assessed at 1, 3, 6, 9, and 12 months (range: 0-100; higher scores indicate better health status or quality of life)"}, {'measure': 'Improvement in subjective symptoms (3)', 'timeFrame': 'Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline', 'description': "Evaluation of reductions from baseline in patients' self-reported symptoms (using COPD Assessment Test (CAT) score) assessed at 1, 3, 6, 9, and 12 months (range: 0-40; higher scores indicate worse health status or greater impact of COPD symptoms)"}, {'measure': 'Improvement in objective assessment', 'timeFrame': 'Forced Vital Capacity (FVC) measured in liters (L): 12 months from baseline', 'description': "Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Vital Capacity (FVC) measured in liters (L), at 12 months."}, {'measure': 'Improvement in objective assessment', 'timeFrame': 'Forced Vital Capacity (FVC) expressed as a percentage of predicted value (FVC %): 12 months from baseline', 'description': "Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Vital Capacity (FVC) expressed as a percentage of predicted value (FVC %), measured at 12 months."}, {'measure': 'Improvement in objective assessment', 'timeFrame': 'Forced Expiratory Volume in 1 second (FEV1) measured in liters (L): 12 months from baseline', 'description': "Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Expiratory Volume in 1 second (FEV1) measured in liters (L), at 12 months."}, {'measure': 'Improvement in objective assessment', 'timeFrame': 'Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of predicted value (FEV1 %): 12 months from baseline', 'description': "Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of predicted value (FEV1 %), measured at 12 months."}, {'measure': 'Improvement in objective assessment', 'timeFrame': 'the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (FEV1/FVC): 12 months from baseline', 'description': "Evaluation of changes from baseline in patients' pulmonary function, specifically the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (FEV1/FVC), measured at 12 months."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchiectasis', 'aerobika', 'ACBT'], 'conditions': ['Bronchiectasis', 'Bronchiectasis With Acute Exacerbation']}, 'referencesModule': {'references': [{'pmid': '37250647', 'type': 'BACKGROUND', 'citation': 'Kim SR, Kim SH, Kim GH, Cho JY, Choi H, Lee H, Ra SW, Lee KM, Choe KH, Oh YM, Shin YM, Yang B. Effectiveness of the use of an oscillating positive expiratory pressure device in bronchiectasis with frequent exacerbations: a single-arm pilot study. Front Med (Lausanne). 2023 May 12;10:1159227. doi: 10.3389/fmed.2023.1159227. eCollection 2023.'}, {'pmid': '32042786', 'type': 'BACKGROUND', 'citation': 'Yang B, Choi H, Lim JH, Park HY, Kang D, Cho J, Lee JS, Lee SW, Oh YM, Moon JY, Kim SH, Kim TH, Sohn JW, Yoon HJ, Lee H. The disease burden of bronchiectasis in comparison with chronic obstructive pulmonary disease: a national database study in Korea. Ann Transl Med. 2019 Dec;7(23):770. doi: 10.21037/atm.2019.11.55.'}, {'pmid': '30442957', 'type': 'BACKGROUND', 'citation': 'Chalmers JD, Chang AB, Chotirmall SH, Dhar R, McShane PJ. Bronchiectasis. Nat Rev Dis Primers. 2018 Nov 15;4(1):45. doi: 10.1038/s41572-018-0042-3.'}, {'pmid': '30545985', 'type': 'BACKGROUND', 'citation': 'Hill AT, Sullivan AL, Chalmers JD, De Soyza A, Elborn SJ, Floto AR, Grillo L, Gruffydd-Jones K, Harvey A, Haworth CS, Hiscocks E, Hurst JR, Johnson C, Kelleher PW, Bedi P, Payne K, Saleh H, Screaton NJ, Smith M, Tunney M, Whitters D, Wilson R, Loebinger MR. British Thoracic Society Guideline for bronchiectasis in adults. Thorax. 2019 Jan;74(Suppl 1):1-69. doi: 10.1136/thoraxjnl-2018-212463. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Title:\n\nComparison of Effectiveness Between Active Cycle of Breathing Techniques (ACBT) and Oscillating Positive Expiratory Pressure (OPEP, Aerobika) Device Assisted Treatment in Patients With Bronchiectasis in Korea: A Randomized Controlled Trial\n\nPurpose:\n\nThis study aims to evaluate the effectiveness of Active Cycle of Breathing Techniques (ACBT) alone versus ACBT combined with an Oscillating Positive Expiratory Pressure (OPEP) device (Aerobika) in patients with bronchiectasis. The goal is to determine whether the combination therapy reduces the frequency of acute exacerbations and improves patient symptoms compared to ACBT alone.\n\nPrimary Questions:\n\nDoes the use of ACBT plus Aerobika reduce the number of acute exacerbations in patients with bronchiectasis who experience ≥3 exacerbations per year?\n\nWhat symptoms and adverse events are observed in participants using the Aerobika device?\n\nStudy Design:\n\nThis is a single-center, randomized, controlled clinical trial conducted at Chungbuk National University Hospital in Korea. 100 adult patients diagnosed with bronchiectasis and having ≥3 acute exacerbations within 1 year will be enrolled and randomized into two groups (1:1):\n\nActive Cycle of Breathing Technique (ACBT) group\n\nActive Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group\n\nThe intervention period lasts 12 months, with clinic visits scheduled at 0, 1, 3, 6, 9, and 12 months.\n\nParticipation Involves:\n\nUse of ACBT with or without Aerobika daily for 12 months\n\nIn-person clinic visits every 1 to 3 months\n\nMonthly phone follow-ups to assess symptoms and adverse events\n\nCompletion of questionnaires (mMRC, BHQ, CAT) and clinical tests including PFT and laboratory tests\n\nTracking of exacerbation frequency, sputum volume, and quality', 'detailedDescription': 'Primary Questions:\n\nDoes the use of ACBT plus Aerobika reduce the number of acute exacerbations in patients with bronchiectasis who experience ≥3 exacerbations per year?\n\nAnswer) To date, no studies have demonstrated that the use of ACBT plus Aerobika reduces acute exacerbations in patients with bronchiectasis who experience frequent exacerbations.\n\nWhat symptoms and adverse events are observed in participants using the Aerobika device?\n\nAnswer) Oscillating PEP devices are not recommended in patients with neuromuscular weakness, recent head and neck surgery or trauma, active hemoptysis, untreated pneumothorax, and middle ear disease\n\nRef. Coppolo DP, Schloss J, Suggett JA, Mitchell JP. Non-Pharmaceutical Techniques for Obstructive Airway Clearance Focusing on the Role of Oscillating Positive Expiratory Pressure (OPEP): A Narrative Review. Pulm Ther. (2022) 8:1-41.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Patients diagnosed with bronchiectasis involving one or more lobes on chest computed tomography (CT)\n* Patients experiencing frequent exacerbations (3 or more exacerbations) within 1 year\n* Patients able and willing to use the Aerobika device (OPEP)\n\nExclusion Criteria:\n\n* Diagnosis of bronchiectasis due to cystic fibrosis\n* Traction bronchiectasis due to interstitial lung disease (ILD)\n* Pregnant patients\n* Patients with a history of OPEP device use\n* Patients who cannot tolerate increased breathing work\n* Hemodynamic instability (e.g., unstable blood pressure)\n* Patients with a past or current history of hemoptysis (pulmonary bleeding) and untreated pneumothorax'}, 'identificationModule': {'nctId': 'NCT07037303', 'briefTitle': 'Comparing Active Cycle of Breathing Techniques (ACBT) and Aerobika in Treating Bronchiectasis in Korea', 'organization': {'class': 'OTHER', 'fullName': 'Chungbuk National University Hospital'}, 'officialTitle': 'Comparison of Effectiveness Between Active Cycle of Breathing Techniques (ACBT) and Oscillating Positive Expiratory Pressure (OPEP, Aerobika) Device Assisted Treatment in Patients With Bronchiectasis in Korea : Randomized Controlled Trials', 'orgStudyIdInfo': {'id': 'IRB No. 2025-02-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Cycle of Breathing Technique (ACBT) group', 'description': 'patients with bronchiectasis using ACBT', 'interventionNames': ['Device: Active Cycle of Breathing Technique (ACBT) group']}, {'type': 'EXPERIMENTAL', 'label': 'Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group', 'description': 'Patients with bronchiectasis using ACBT and OPEP simultaneously', 'interventionNames': ['Device: Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group']}], 'interventions': [{'name': 'Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group', 'type': 'DEVICE', 'description': 'Patients with bronchiectasis using ACT and OPEP simultaneously', 'armGroupLabels': ['Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group']}, {'name': 'Active Cycle of Breathing Technique (ACBT) group', 'type': 'DEVICE', 'description': 'Patients will receive only ACBT for airway clearance.', 'armGroupLabels': ['Active Cycle of Breathing Technique (ACBT) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28644', 'city': 'Cheongju-si', 'state': 'North Chungcheong', 'country': 'South Korea', 'contacts': [{'name': 'Bumhee Yang, MD, PhD', 'role': 'CONTACT', 'email': 'ybhworld0415@gmail.com', 'phone': '+82-43-269-8210'}, {'name': 'Bumhee Yang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}], 'centralContacts': [{'name': 'Bumhee Yang, MD, PhD', 'role': 'CONTACT', 'email': 'ybhworld0415@gmail.com', 'phone': '+82 43-269-8210'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chungbuk National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Trudell Medical International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Bumhee Yang, MD', 'investigatorAffiliation': 'Chungbuk National University Hospital'}}}}