Comparing Active Cycle of Breathing Techniques (ACBT) and Aerobika in Treating Bronchiectasis in Korea

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group
  Patients with bronchiectasis using ACT and OPEP simultaneously
• Устройство Active Cycle of Breathing Technique (ACBT) group
  Patients will receive only ACBT for airway clearance.

Первичные конечные точки

• Frequency of Acute Exacerbations in Patients with Bronchiectasis [Срок оценки: 12 months from baseline]

Вторичные конечные точки (8)

• Improvement in subjective symptoms (1) [Срок оценки: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline]
• Improvement in subjective symptoms (2) [Срок оценки: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline]
• Improvement in subjective symptoms (3) [Срок оценки: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline]
• Improvement in objective assessment [Срок оценки: Forced Vital Capacity (FVC) measured in liters (L): 12 months from baseline]
• Improvement in objective assessment [Срок оценки: Forced Vital Capacity (FVC) expressed as a percentage of predicted value (FVC %): 12 months from baseline]
• Improvement in objective assessment [Срок оценки: Forced Expiratory Volume in 1 second (FEV1) measured in liters (L): 12 months from baseline]
• Improvement in objective assessment [Срок оценки: Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of predicted value (FEV1 %): 12 months from baseline]
• Improvement in objective assessment [Срок оценки: the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (FEV1/FVC): 12 months from baseline]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Chungbuk National University Hospital — Cheongju-si

Публикации

• 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 37250647
• 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 32042786
• 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 30442957
• 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 abs PMID 30545985

Идентификаторы

NCT: NCT07037303 · IRB No. 2025-02-031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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