Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT07037303
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
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:
NCT07037303
Study Brief:
Protocol Section:
NCT07037303