NCT03013452

Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis

A Randomized Controlled Trial of Long Term Airway Clearance With Oscillating Positive End Expiratory Pressure Device Versus Autogenic Drainage in People With Bronchiectasis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Carmel Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI), 50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage.

Detailed description

One of the fundamental treatments in the management of bronchiectasis is airway clearance, which effectively rids the airways of mucus to prevent secondary infection and inflammation. While effective airway clearance is widely accepted as a first line treatment, the choice of airway clearance method is complicated by lacking evidence base. One of the obstacles to establishing evidence of efficacy of an airway clearance technique or device is the limitations in the choice of endpoints. Aerobika (Trudell medical international, Canada) is an oscillating positive expiratory pressure (oPEP) device, designed and developed for the effective clearance of secretions in people with suppurative lung diseases. It has been tested and found safe and effective in chronic obstructive pulmonary disease (COPD) - chronic bronchitis. The lung clearance index (LCI) measured by multiple breath washout (MBW) is a measure of ventilation inhomogeneity and has been shown to be a sensitive lung function test in early lung disease. Its usefulness has been demonstrated in cystic fibrosis (CF), particularly in children and adults with mild disease. LCI has been assessed in bronchiectasis and has been found to be significantly different from normal subjects, and to correlate with Forced Expiratory Volume in 1 second (FEV1). The aim of this study is to test the long term effect of daily lung clearance on LCI, quality of life and exacerbations using the Aerobika oPEP device versus autogenic drainage (AD) in people with bronchiectasis. 50 patients with confirmed bronchiectasis will be enrolled in this study. Participants will be randomized to daily physiotherapy with either Aerobika or Autogenic drainage. Change in LCI, measured before and after one month, will be the primary endpoint of this study.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DEVICE	oPEP	Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.
BEHAVIORAL	Autogenic drainage	Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.

Timeline

• Start date: 2017-03-09
• Primary completion: 2019-12-30
• Completion: 2020-06-30
• First posted: 2017-01-06
• Last updated: 2019-07-26

Locations

2 sites across 1 country: Israel