Clinical trial NCT03013452: Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiectasis
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
Collaborators: name: Rambam Health Care Campus
First posted: 2017-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in LCI
timeFrame: 1 month
Secondary outcomes:
measure: Total score on QOL- B questionnaire
timeFrame: 1 month
measure: Score on respiratory domain of QOL-B questionnaire
timeFrame: 1 month
measure: FEV1 (% predicted)- difference from baseline
timeFrame: 1 month
measure: Forced Expiratory Volume (FVC) (% predicted)- difference from baseline
timeFrame: 1 month
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Pulmonology Institute, Carmel Medical Center
Study officials:
References:
citation: Flude LJ, Agent P, Bilton D. Chest physiotherapy techniques in bronchiectasis. Clin Chest Med. 2012 Jun;33(2):351-61. doi: 10.1016/j.ccm.2012.02.009. Epub 2012 Apr 4.
citation: Robinson PD, Latzin P, Verbanck S, Hall GL, Horsley A, Gappa M, Thamrin C, Arets HG, Aurora P, Fuchs SI, King GG, Lum S, Macleod K, Paiva M, Pillow JJ, Ranganathan S, Ratjen F, Singer F, Sonnappa S, Stocks J, Subbarao P, Thompson BR, Gustafsson PM. Consensus statement for inert gas washout measurement using multiple- and single- breath tests. Eur Respir J. 2013 Mar;41(3):507-22. doi: 10.1183/09031936.00069712. Epub 2013 Feb 8.
citation: Gonem S, Scadding A, Soares M, Singapuri A, Gustafsson P, Ohri C, Range S, Brightling CE, Pavord I, Horsley A, Siddiqui S. Lung clearance index in adults with non-cystic fibrosis bronchiectasis. Respir Res. 2014 May 18;15(1):59. doi: 10.1186/1465-9921-15-59.
citation: Rowan SA, Bradley JM, Bradbury I, Lawson J, Lynch T, Gustafsson P, Horsley A, O'Neill K, Ennis M, Elborn JS. Lung clearance index is a repeatable and sensitive indicator of radiological changes in bronchiectasis. Am J Respir Crit Care Med. 2014 Mar 1;189(5):586-92. doi: 10.1164/rccm.201310-1747OC.