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

NCT07037303 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-25

No results posted yet for this study

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

Interventions

DEVICE

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

Patients with bronchiectasis using ACT and OPEP simultaneously

DEVICE

Active Cycle of Breathing Technique (ACBT) group

Patients will receive only ACBT for airway clearance.

Sponsors & Collaborators

  • Trudell Medical International

    collaborator INDUSTRY

  • Chungbuk National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-06-01
Completion
2028-07-01

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07037303 on ClinicalTrials.gov