Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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

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Bronchiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autogenic drainage

Chest physiotherapy by autogenic drainage daily for 15 minutes each day, for 1 month. Instruction by a physiotherapist as to proper technique will be given at the beginning of the study.

Group Type ACTIVE_COMPARATOR

Autogenic drainage

Intervention Type BEHAVIORAL

Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.

oPEP

Chest physiotherapy with an Aerobika oPEP device daily for 15 minutes each day for 1 month. Instruction by a physiotherapist as to proper technique will be given at the beginning of the study.

Group Type ACTIVE_COMPARATOR

oPEP

Intervention Type DEVICE

Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.

Interventions

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oPEP

Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.

Intervention Type DEVICE

Autogenic drainage

Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.

Intervention Type BEHAVIORAL

Other Intervention Names

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Aerobika device

Eligibility Criteria

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Inclusion Criteria

1. High Resolution chest computerized tomography (HRCT) during stable disease imaging bronchiectasis in at least 2 lung lobes
2. Sputum production during most days of the year
3. Stable chronic therapy during last 4 weeks
4. FEV1 = 70% predicted or higher on spirometry
5. Able to give informed consent or assent
6. Age: 18- 80 years

Exclusion Criteria

1. An exacerbation during last 4 weeks before randomization
2. Any change in respiratory medications during the past 4 weeks before randomization
3. A diagnosis of cystic fibrosis
4. A diagnosis of primary ciliary dyskinesia

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No