Bronchiectasis
Conditions
Brief 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.
Interventions
DEVICEoPEP
Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.
BEHAVIORALAutogenic drainage
Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.
Sponsors
Rambam Health Care Campus
Carmel Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LCI | 1 month | LCI will be determined before intervention and after 1 month and change will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total score on QOL- B questionnaire | 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 | 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 | 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 | 1 month | Spirometry will be performed before and after 1 month of the intervention, and change in FVC (% of predicted) will be recorded. |
Countries
Israel
Outcome results
None listed