An interventional study of Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group and Active Cycle of Breathing Technique (ACBT) group in Bronchiectasis and Bronchiectasis With Acute Exacerbation, sponsored by Chungbuk National University Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Chungbuk National University Hospital · Not applicable, Interventional, and Treatment
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
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?
Answer) To date, no studies have demonstrated that the use of ACBT plus Aerobika reduces acute exacerbations in patients with bronchiectasis who experience frequent exacerbations.
What symptoms and adverse events are observed in participants using the Aerobika device?
Answer) 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
Ref. 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.
368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 233 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Chungbuk National University Hospital is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients with bronchiectasis using ACBT
Device: Active Cycle of Breathing Technique (ACBT) group
Patients with bronchiectasis using ACBT and OPEP simultaneously
Device: Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group
Patients with bronchiectasis using ACT and OPEP simultaneously
Patients 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.
Time frame: 12 months from baseline
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)
Time frame: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline
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)
Time frame: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline
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)
Time frame: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline
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.
Time frame: Forced Vital Capacity (FVC) measured in liters (L): 12 months from baseline
Improvement in objective assessment
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.
Time frame: Forced Vital Capacity (FVC) expressed as a percentage of predicted value (FVC %): 12 months from baseline
Improvement in objective assessment
Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Expiratory Volume in 1 second (FEV1) measured in liters (L), at 12 months.
Time frame: Forced Expiratory Volume in 1 second (FEV1) measured in liters (L): 12 months from baseline
Improvement in objective assessment
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.
Time frame: Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of predicted value (FEV1 %): 12 months from baseline
Improvement in objective assessment
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.
Time frame: the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (FEV1/FVC): 12 months from baseline
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chungbuk National University Hospital