Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis

Last updated: July 25, 2019
Sponsor: Carmel Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bronchiectasis

Treatment

N/A

Clinical Study ID

NCT03013452
CMC-16-0087-CTIL
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. High Resolution chest computerized tomography (HRCT) during stable disease imagingbronchiectasis 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

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

Total Participants: 50
Study Start date:
March 09, 2017
Estimated Completion Date:
June 30, 2020

Study 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.

Connect with a study center

  • Carmel Medical Center

    Haifa, 3436209
    Israel

    Active - Recruiting

  • Pulmonology Institute, Carmel Medical Center

    Haifa, 34362
    Israel

    Active - Recruiting

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