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.

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