<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03013452</url>
  </required_header>
  <id_info>
    <org_study_id>CMC-16-0087-CTIL</org_study_id>
    <nct_id>NCT03013452</nct_id>
  </id_info>
  <brief_title>Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis</brief_title>
  <acronym>oPEP-vs-AD</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Carmel Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, investigating two modes of chest physiotherapy on lung clearance index (LCI),&#xD;
      50 patients with bronchiectasis will be randomized to either oPEP or autogenic drainage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the fundamental treatments in the management of bronchiectasis is airway clearance,&#xD;
      which effectively rids the airways of mucus to prevent secondary infection and inflammation.&#xD;
      While effective airway clearance is widely accepted as a first line treatment, the choice of&#xD;
      airway clearance method is complicated by lacking evidence base. One of the obstacles to&#xD;
      establishing evidence of efficacy of an airway clearance technique or device is the&#xD;
      limitations in the choice of endpoints.&#xD;
&#xD;
      Aerobika (Trudell medical international, Canada) is an oscillating positive expiratory&#xD;
      pressure (oPEP) device, designed and developed for the effective clearance of secretions in&#xD;
      people with suppurative lung diseases. It has been tested and found safe and effective in&#xD;
      chronic obstructive pulmonary disease (COPD) - chronic bronchitis.&#xD;
&#xD;
      The lung clearance index (LCI) measured by multiple breath washout (MBW) is a measure of&#xD;
      ventilation inhomogeneity and has been shown to be a sensitive lung function test in early&#xD;
      lung disease. Its usefulness has been demonstrated in cystic fibrosis (CF), particularly in&#xD;
      children and adults with mild disease. LCI has been assessed in bronchiectasis and has been&#xD;
      found to be significantly different from normal subjects, and to correlate with Forced&#xD;
      Expiratory Volume in 1 second (FEV1).&#xD;
&#xD;
      The aim of this study is to test the long term effect of daily lung clearance on LCI, quality&#xD;
      of life and exacerbations using the Aerobika oPEP device versus autogenic drainage (AD) in&#xD;
      people with bronchiectasis.&#xD;
&#xD;
      50 patients with confirmed bronchiectasis will be enrolled in this study. Participants will&#xD;
      be randomized to daily physiotherapy with either Aerobika or Autogenic drainage. Change in&#xD;
      LCI, measured before and after one month, will be the primary endpoint of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 9, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in LCI</measure>
    <time_frame>1 month</time_frame>
    <description>LCI will be determined before intervention and after 1 month and change will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total score on QOL- B questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and total score will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on respiratory domain of QOL-B questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and score on respiratory domain will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1 (% predicted)- difference from baseline</measure>
    <time_frame>1 month</time_frame>
    <description>Spirometry will be performed before and after 1 month of the intervention, and change in FEV1 (% of predicted) will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume (FVC) (% predicted)- difference from baseline</measure>
    <time_frame>1 month</time_frame>
    <description>Spirometry will be performed before and after 1 month of the intervention, and change in FVC (% of predicted) will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Bronchiectasis</condition>
  <arm_group>
    <arm_group_label>Autogenic drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oPEP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>oPEP</intervention_name>
    <description>Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.</description>
    <arm_group_label>oPEP</arm_group_label>
    <other_name>Aerobika device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Autogenic drainage</intervention_name>
    <description>Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.</description>
    <arm_group_label>Autogenic drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. High Resolution chest computerized tomography (HRCT) during stable disease imaging&#xD;
             bronchiectasis in at least 2 lung lobes&#xD;
&#xD;
          2. Sputum production during most days of the year&#xD;
&#xD;
          3. Stable chronic therapy during last 4 weeks&#xD;
&#xD;
          4. FEV1 = 70% predicted or higher on spirometry&#xD;
&#xD;
          5. Able to give informed consent or assent&#xD;
&#xD;
          6. Age: 18- 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. An exacerbation during last 4 weeks before randomization&#xD;
&#xD;
          2. Any change in respiratory medications during the past 4 weeks before randomization&#xD;
&#xD;
          3. A diagnosis of cystic fibrosis&#xD;
&#xD;
          4. A diagnosis of primary ciliary dyskinesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3436209</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michal Shteinberg, Md PhD</last_name>
      <phone>972506265846</phone>
      <email>michalsh4@clalit.org.il</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pulmonology Institute, Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michal Shteinberg, MD, PhD</last_name>
      <phone>97248250517</phone>
      <email>michal.shteinberg@gmail.com</email>
    </contact>
    <contact_backup>
      <phone>97248250517</phone>
    </contact_backup>
    <investigator>
      <last_name>Yochai Adir, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michal Shteinberg, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Assaf Jacobi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <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>
    <PMID>22640850</PMID>
  </reference>
  <reference>
    <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].</citation>
    <PMID>23397305</PMID>
  </reference>
  <results_reference>
    <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>
    <PMID>24884343</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>24428575</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>July 25, 2019</last_update_submitted>
  <last_update_submitted_qc>July 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiectasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03013452
org study id: CMC-16-0087-CTIL
nct id: NCT03013452
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 modes of physiotherapy: 1- autogenic drainage; 2- oscillating positive expiratory pressure device
primary purpose: Treatment
masking: None (Open Label)
measure: Change in LCI
time frame: 1 month
description: LCI will be determined before intervention and after 1 month and change will be recorded.
measure: Total score on QOL- B questionnaire
time frame: 1 month
description: Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and total score will be recorded.
measure: Score on respiratory domain of QOL-B questionnaire
time frame: 1 month
description: Patients will answer QOL-B questionnaire before and after 1 month of the intervention, and score on respiratory domain will be recorded.
measure: FEV1 (% predicted)- difference from baseline
time frame: 1 month
description: Spirometry will be performed before and after 1 month of the intervention, and change in FEV1 (% of predicted) will be recorded.
measure: Forced Expiratory Volume (FVC) (% predicted)- difference from baseline
time frame: 1 month
description: Spirometry will be performed before and after 1 month of the intervention, and change in FVC (% of predicted) will be recorded.
arm group label: Autogenic drainage
arm group type: Active Comparator
description: 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.
arm group label: oPEP
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: oPEP
description: Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.
arm group label: oPEP
other name: Aerobika device
intervention type: Behavioral
intervention name: Autogenic drainage
description: Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.
arm group label: Autogenic drainage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Israel
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.
PMID: 22640850
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].
PMID: 23397305
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.
PMID: 24884343
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.
PMID: 24428575
responsible party type: Sponsor
mesh term: Bronchiectasis
sharing ipd: No