Bronchiectasis, Bronchiectasis With Acute Exacerbation
Conditions
Keywords
bronchiectasis, aerobika, ACBT
Brief summary
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
Detailed description
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.
Interventions
DEVICEActive Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group
Patients with bronchiectasis using ACT and OPEP simultaneously
DEVICEActive Cycle of Breathing Technique (ACBT) group
Patients will receive only ACBT for airway clearance.
Sponsors
Trudell Medical International
Chungbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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 * Patients who cannot tolerate increased breathing work * Hemodynamic instability (e.g., unstable blood pressure) * Patients with a past or current history of hemoptysis (pulmonary bleeding) and untreated pneumothorax
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Acute Exacerbations in Patients with Bronchiectasis | 12 months from baseline | Number of acute exacerbations experienced by patients diagnosed with bronchiectasis during the 12-month study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in subjective symptoms (1) | Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline | 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) | Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline | 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) | Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline | 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 | Forced Vital Capacity (FVC) measured in liters (L): 12 months from baseline | Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Vital Capacity (FVC) measured in liters (L), at 12 months. |
Countries
South Korea
Contacts
Primary ContactBumhee Yang, MD, PhD
Outcome results
None listed