Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis

Study Overview
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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.

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.

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

Conditions
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Bronchiectasis

Intervention / Treatment
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* Device: oPEP
* Behavioral: Autogenic drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High Resolution chest computerized tomography (HRCT) during stable disease imaging bronchiectasis in at least 2 lung lobes Sputum production during most days of the year Stable chronic therapy during last 4 weeks FEV1 = 70% predicted or higher on spirometry Able to give informed consent or assent Age: 18- 80 years Exclusion Criteria: An exacerbation during last 4 weeks before randomization Any change in respiratory medications during the past 4 weeks before randomization A diagnosis of cystic fibrosis A diagnosis of primary ciliary dyskinesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autogenic drainage<br>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. | Behavioral: Autogenic drainage<br>* Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.<br>|
| Active Comparator: oPEP<br>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. | Device: oPEP<br>* Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.<br>* Other names: Aerobika device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LCI | LCI will be determined before intervention and after 1 month and change will be recorded. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score on QOL- B questionnaire | Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and total score will be recorded. | 1 month | 
| Score on respiratory domain of QOL-B questionnaire | Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and score on respiratory domain will be recorded. | 1 month | 
| FEV1 (% predicted)- difference from baseline | Spirometry will be performed before and after 1 month of the intervention, and change in FEV1 (% of predicted) will be recorded. | 1 month | 
| Forced Expiratory Volume (FVC) (% predicted)- difference from baseline | Spirometry will be performed before and after 1 month of the intervention, and change in FVC (% of predicted) will be recorded. | 1 month |