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NCT Number: NCT07037303

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

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

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Key information

Conditions

Bronchiectasis Bronchial Diseases Bronchiectasis With Acute Exacerbation Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location contact

Bumhee Yang, MD, PhD

CONTACT

[email protected]

+82-43-269-8210

Bumhee Yang, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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) group

Device

Patients will receive only ACBT for airway clearance.

Primary outcomes

  1. Frequency of Acute Exacerbations in Patients with Bronchiectasis

    Time frame: 12 months from baseline

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

Secondary outcomes

  1. Improvement in subjective symptoms (1)

    Time frame: 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)

  2. Improvement in subjective symptoms (2)

    Time frame: 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)

  3. Improvement in subjective symptoms (3)

    Time frame: 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)

  4. Improvement in objective assessment

    Time frame: 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.

  5. Improvement in objective assessment

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

    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.

  6. Improvement in objective assessment

    Time frame: Forced Expiratory Volume in 1 second (FEV1) measured in liters (L): 12 months from baseline

    Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Expiratory Volume in 1 second (FEV1) measured in liters (L), at 12 months.

  7. Improvement in objective assessment

    Time frame: Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of predicted value (FEV1 %): 12 months from baseline

    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.

  8. Improvement in objective assessment

    Time frame: the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (FEV1/FVC): 12 months from baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bumhee Yang, MD, PhD

CONTACT

[email protected]

+82 43-269-8210

Sponsors and collaborators

Lead sponsor

Chungbuk National University Hospital

Other

Collaborators

  • Trudell Medical International

Registry information

Official study 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 : Randomized Controlled Trials

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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