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

NCT07037303 | Not Yet Recruiting DMC

• 1 other identifier: IRB No. 2025-02-031
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchiectasis; Bronchiectasis With Acute Exacerbation

Keywords

bronchiectasis; aerobika; ACBT

Outcome Measures

Primary Outcomes (1)

• Frequency of Acute Exacerbations in Patients with Bronchiectasis

  Number of acute exacerbations experienced by patients diagnosed with bronchiectasis during the 12-month study period.

  12 months from baseline

Secondary Outcomes (8)

• Improvement in subjective symptoms (1)

  Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline

• Improvement in subjective symptoms (2)

  Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline

• Improvement in subjective symptoms (3)

  Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline

• Improvement in objective assessment

  Forced Vital Capacity (FVC) measured in liters (L): 12 months from baseline

• Improvement in objective assessment

  Forced Vital Capacity (FVC) expressed as a percentage of predicted value (FVC %): 12 months from baseline

Study Arms (2)

Active Cycle of Breathing Technique (ACBT) group

ACTIVE COMPARATOR

patients with bronchiectasis using ACBT

Device: Active Cycle of Breathing Technique (ACBT) group

Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group

EXPERIMENTAL

Patients with bronchiectasis using ACBT and OPEP simultaneously

Device: Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group

Interventions

Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group DEVICE

Patients with bronchiectasis using ACT and OPEP simultaneously

Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group

Active Cycle of Breathing Technique (ACBT) group DEVICE

Patients will receive only ACBT for airway clearance.

Active Cycle of Breathing Technique (ACBT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chungbuk National University Hospital: lead
• Trudell Medical International: collaborator

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 abstract available.

  PMID: 30545985 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Central Study Contacts

Bumhee Yang, MD, PhD

CONTACT

+82 43-269-8210; ybhworld0415@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)