Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis

Not Applicable

• Conditions: Bronchiectasis
• Interventions: Behavioral: Autogenic drainage; Device: oPEP

• Registration Number: NCT03013452
• Lead Sponsor: Carmel Medical Center

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.

Study Timeline

• Study First Submitted: 2017-01-01
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Study Start: 2017-03-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26
• Primary Completion: 2019-12-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autogenic drainage	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.
oPEP	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.

Primary Outcome Measures

Name	Time	Method
Change in LCI	1 month	LCI will be determined before intervention and after 1 month and change will be recorded.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Carmel Medical Center; 🇮🇱 Haifa, Israel

Pulmonology Institute, Carmel Medical Center; 🇮🇱 Haifa, Israel