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Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis (oPEP-vs-AD)

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ClinicalTrials.gov Identifier: NCT03013452
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Device: oPEP Behavioral: Autogenic drainage Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 9, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Autogenic drainage
Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.

Active Comparator: 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.
Device: oPEP
Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.
Other Name: Aerobika device




Primary Outcome Measures :
  1. Change in LCI [ Time Frame: 1 month ]
    LCI will be determined before intervention and after 1 month and change will be recorded.


Secondary Outcome Measures :
  1. Total score on QOL- B questionnaire [ Time Frame: 1 month ]
    Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and total score will be recorded.

  2. Score on respiratory domain of QOL-B questionnaire [ Time Frame: 1 month ]
    Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and score on respiratory domain will be recorded.

  3. FEV1 (% predicted)- difference from baseline [ Time Frame: 1 month ]
    Spirometry will be performed before and after 1 month of the intervention, and change in FEV1 (% of predicted) will be recorded.

  4. Forced Expiratory Volume (FVC) (% predicted)- difference from baseline [ Time Frame: 1 month ]
    Spirometry will be performed before and after 1 month of the intervention, and change in FVC (% of predicted) will be recorded.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013452


Locations
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Israel
Carmel Medical Center Recruiting
Haifa, Israel, 3436209
Contact: Michal Shteinberg, Md PhD    972506265846    michalsh4@clalit.org.il   
Pulmonology Institute, Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Michal Shteinberg, MD, PhD    97248250517    michal.shteinberg@gmail.com   
Contact    97248250517      
Sub-Investigator: Yochai Adir, MD         
Principal Investigator: Michal Shteinberg, MD, PhD         
Sub-Investigator: Assaf Jacobi, MD         
Sponsors and Collaborators
Carmel Medical Center
Rambam Health Care Campus

Publications of Results:
Other Publications:
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Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT03013452     History of Changes
Other Study ID Numbers: CMC-16-0087-CTIL
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases