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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2028-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD

NCT02282202

Chronic Obstructive Pulmonary Disease Bronchiectasis

COMPLETED NA

A Feasibility RCT of Aerobika Verses ACBT in People With COPD

NCT05548036

COPD Bronchiolitis

UNKNOWN NA

Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

NCT06393257

Bronchiectasis Adult

RECRUITING NA

Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study

NCT06970054

COPD AECOPD

NOT_YET_RECRUITING NA

Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT03299231

Pulmonary Disease, Chronic Obstructive

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchiectasis Bronchiectasis With Acute Exacerbation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Cycle of Breathing Technique (ACBT) group

patients with bronchiectasis using ACBT

Group Type ACTIVE_COMPARATOR

Active Cycle of Breathing Technique (ACBT) group

Intervention Type DEVICE

Patients will receive only ACBT for airway clearance.

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

Patients with bronchiectasis using ACBT and OPEP simultaneously

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Patients with bronchiectasis using ACT and OPEP simultaneously

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Patients with bronchiectasis using ACT and OPEP simultaneously

Intervention Type DEVICE

Active Cycle of Breathing Technique (ACBT) group

Patients will receive only ACBT for airway clearance.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes