Title:
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: A Randomized Controlled Trial
Purpose:
This 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.
Primary Questions:
Does the use of ACBT plus Aerobika reduce the number of acute exacerbations in patients with bronchiectasis who experience ≥3 exacerbations per year?
What symptoms and adverse events are observed in participants using the Aerobika device?
Study Design:
This 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):
Active Cycle of Breathing Technique (ACBT) group
Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group
The intervention period lasts 12 months, with clinic visits scheduled at 0, 1, 3, 6, 9, and 12 months.
Participation Involves:
Use of ACBT with or without Aerobika daily for 12 months
In-person clinic visits every 1 to 3 months
Monthly phone follow-ups to assess symptoms and adverse events
Completion of questionnaires (mMRC, BHQ, CAT) and clinical tests including PFT and laboratory tests
Tracking of exacerbation frequency, sputum volume, and quality
18 years of age or older
Patients diagnosed with bronchiectasis involving one or more lobes on chest computed tomography (CT)
Patients experiencing frequent exacerbations (3 or more exacerbations) within 1 year
Patients able and willing to use the Aerobika device (OPEP)
Diagnosis of bronchiectasis due to cystic fibrosis
Traction bronchiectasis due to interstitial lung disease (ILD)
Pregnant patients
Patients with a history of OPEP device use
Parallel
Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group
DevicePatients with bronchiectasis using ACT and OPEP simultaneously
Active Cycle of Breathing Technique (ACBT) group
DevicePatients will receive only ACBT for airway clearance.
Frequency of Acute Exacerbations in Patients with Bronchiectasis
Number of acute exacerbations experienced by patients diagnosed with bronchiectasis during the 12-month study period.
Improvement in subjective symptoms (1)
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)
Improvement in subjective symptoms (2)
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)
Improvement in subjective symptoms (3)
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)
Improvement in objective assessment
Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Vital Capacity (FVC) measured in liters (L), at 12 months.
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Chungbuk National University Hospital
Lead sponsor
Trudell Medical International
Collaborator
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