Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis (oPEP-vs-AD)
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|ClinicalTrials.gov Identifier: NCT03013452|
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : July 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Device: oPEP Behavioral: Autogenic drainage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Long Term Airway Clearance With Oscillating Positive End Expiratory Pressure Device Versus Autogenic Drainage in People With Bronchiectasis|
|Actual Study Start Date :||March 9, 2017|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Active Comparator: 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.
Behavioral: Autogenic drainage
Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.
Active Comparator: 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.
Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.
Other Name: Aerobika device
- Change in LCI [ Time Frame: 1 month ]LCI will be determined before intervention and after 1 month and change will be recorded.
- Total score on QOL- B questionnaire [ Time Frame: 1 month ]Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and total score will be recorded.
- Score on respiratory domain of QOL-B questionnaire [ Time Frame: 1 month ]Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and score on respiratory domain will be recorded.
- FEV1 (% predicted)- difference from baseline [ Time Frame: 1 month ]Spirometry will be performed before and after 1 month of the intervention, and change in FEV1 (% of predicted) will be recorded.
- Forced Expiratory Volume (FVC) (% predicted)- difference from baseline [ Time Frame: 1 month ]Spirometry will be performed before and after 1 month of the intervention, and change in FVC (% of predicted) will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013452
|Carmel Medical Center||Recruiting|
|Haifa, Israel, 3436209|
|Contact: Michal Shteinberg, Md PhD 972506265846 email@example.com|
|Pulmonology Institute, Carmel Medical Center||Recruiting|
|Haifa, Israel, 34362|
|Contact: Michal Shteinberg, MD, PhD 97248250517 firstname.lastname@example.org|
|Sub-Investigator: Yochai Adir, MD|
|Principal Investigator: Michal Shteinberg, MD, PhD|
|Sub-Investigator: Assaf Jacobi, MD|