Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis

Bronchiectasis Clinical Trial

— oPEP-vs-AD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03013452
• Other study ID #: CMC-16-0087-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2019
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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

Behavioral:
• Autogenic drainage
Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa
Israel	Pulmonology Institute, Carmel Medical Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Carmel Medical Center	Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. Review. — View 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;15:59. doi: 10.1186/1465-9921-15-59. — View 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. Erratum in: Eur Respir J. 2013 Nov;42(5):1432. Ranganathan, Sarah [corrected to Ranganathan, Sarath]. — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LCI	LCI will be determined before intervention and after 1 month and change will be recorded.	1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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