BronchiectasisNCT07037303
Comparing Active Cycle of Breathing Techniques (ACBT) and Aerobika in Treating Bronchiectasis in Korea
A study testing Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group and Active Cycle of Breathing Technique (ACBT) group in people with Bronchiectasis and Bronchiectasis With Acute Exacerbation, run by Chungbuk National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis, Bronchiectasis With Acute Exacerbation
- What is being tested?
- Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group and Active Cycle of Breathing Technique (ACBT) group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
Bumhee Yang, MD, PhD, +82-43-269-8210, ybhworld0415@gmail.com
Bumhee Yang, MD, PhD
About this study
Official 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
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
Read more
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
Read the detailed description
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.
- Being tested
- Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group, Active Cycle of Breathing Technique (ACBT) group
- Keywords
- bronchiectasis, aerobika, ACBT
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) groupDevice
Patients with bronchiectasis using ACT and OPEP simultaneously
Active Cycle of Breathing Technique (ACBT) groupDevice
Patients will receive only ACBT for airway clearance.
| Study group | Role | What they receive |
|---|---|---|
| Active Cycle of Breathing Technique (ACBT) group | Active comparator | patients with bronchiectasis using ACBT Receives: 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 Receives: Device: Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Acute Exacerbations in Patients with Bronchiectasis
Number of acute exacerbations experienced by patients diagnosed with bronchiectasis during the 12-month study period.
Measured: 12 months from baseline
Secondary outcomes (8)
Improvement in subjective symptoms (1)
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)
Measured: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline
Improvement in subjective symptoms (2)
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)
Measured: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline
Improvement in subjective symptoms (3)
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)
Measured: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline
Improvement in objective assessment
Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Vital Capacity (FVC) measured in liters (L), at 12 months.
Measured: Forced Vital Capacity (FVC) measured in liters (L): 12 months from baseline
Improvement in objective assessment
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.
Measured: Forced Vital Capacity (FVC) expressed as a percentage of predicted value (FVC %): 12 months from baseline
Improvement in objective assessment
Evaluation of changes from baseline in patients' pulmonary function, specifically Forced Expiratory Volume in 1 second (FEV1) measured in liters (L), at 12 months.
Measured: Forced Expiratory Volume in 1 second (FEV1) measured in liters (L): 12 months from baseline
Improvement in objective assessment
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.
Measured: Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of predicted value (FEV1 %): 12 months from baseline
Improvement in objective assessment
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.
Measured: the ratio of Forced Expiratory Volume in 1 second to Forced Vital Capacity (FEV1/FVC): 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Trudell Medical International
- Responsible party
- Principal investigator, Bumhee Yang, MD, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037303
- Sponsor's protocol ID
- IRB No. 2025-02-031
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37250647Yang 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.
PubMed 32042786Chalmers 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.
PubMed 30442957Hill 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.
PubMed 30545985
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07037303
- Acronym / sponsor ID
- IRB No. 2025-02-031
- Keywords
- bronchiectasis, aerobika, ACBT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chungbuk National University HospitalUniversity, hospital or other
- Collaborators
- Trudell Medical International
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Cycle of Breathing Technique (ACBT) group | Active comparator | Device: Active Cycle of Breathing Technique (ACBT) grouppatients with bronchiectasis using ACBT |
| Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group | Experimental | Device: Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) groupPatients with bronchiectasis using ACBT and OPEP simultaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) groupPatients with bronchiectasis using ACT and OPEP simultaneously | Device | Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group |
| Active Cycle of Breathing Technique (ACBT) groupPatients will receive only ACBT for airway clearance. | Device | Active Cycle of Breathing Technique (ACBT) group |
Primary outcome
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.
8 secondary outcomes
Improvement in subjective symptoms (1)
Time frame: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline
Improvement in subjective symptoms (2)
Time frame: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline
Improvement in subjective symptoms (3)
Time frame: Subjective symptoms: 1, 3, 6, 9, and 12 months from baseline
Improvement in objective assessment
Time frame: Forced Vital Capacity (FVC) measured in liters (L): 12 months from baseline
Improvement in objective assessment
Time frame: Forced Vital Capacity (FVC) expressed as a percentage of predicted value (FVC %): 12 months from baseline
Improvement in objective assessment
Time frame: Forced Expiratory Volume in 1 second (FEV1) measured in liters (L): 12 months from baseline
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 37250647Kim 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.
- Background: PubMed 32042786Yang 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.
- Background: PubMed 30442957Chalmers 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.
- Background: PubMed 30545985Hill 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Cycle of Breathing Technique (ACBT) and Oscillatory Positive Expiratory Pressure (OPEP) group and Active Cycle of Breathing Technique (ACBT) group in people with Bronchiectasis and Bronchiectasis With Acute Exacerbation, run by Chungbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bumhee Yang, MD, PhD (+82 43-269-8210, ybhworld0415@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Acute Exacerbations in Patients with Bronchiectasis (time frame: 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07037303, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.