<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/NCT03299231</url>
  </required_header>
  <id_info>
    <org_study_id>FMASU P56/2017</org_study_id>
    <nct_id>NCT03299231</nct_id>
  </id_info>
  <brief_title>Oscillating Positive Expiratory Pressure Devices and Acute Exacerbation of Chronic Obstructive Pulmonary Disease</brief_title>
  <acronym>SIMPLE</acronym>
  <official_title>Oscillating Positive Expiratory Pressure Device for Mucous Clearing in Severe Exacerbation of COPD Requiring Hospitalization Targeting Outcome: A Randomized, Double Blind, Sham Controlled Trial (SIMPLE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Trudell Medical International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sputum production increases in acute exacerbation of COPD, both in amount and consistency. It&#xD;
      increases airways obstruction and hence delays improvement and prolongs hospital stay.&#xD;
      oscillating positive expiratory pressure (OPEP) devices were extensively studied in cystic&#xD;
      fibrosis and bronchiectasis. Only seldom studied in chronic bronchitis. This study aims to&#xD;
      measure the effects of mucous clearing device in hospitalized patients with acute&#xD;
      exacerbation of COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, investigators will investigate the change of objective measurements of lung&#xD;
      functions and exercise capacity in addition to subjective measures of quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    COVID 19 consequences&#xD;
  </why_stopped>
  <start_date type="Actual">January 22, 2018</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Randomization carried by a third party not involved in the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>percent change of Forced expiratory volume in first second (FEV1)</measure>
    <time_frame>at 12 weeks after hospital discharge</time_frame>
    <description>change in volume of air expired forcefully in first second of expiration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percent change of Forced vital capacity (FVC)</measure>
    <time_frame>at 12 weeks after hospital discharge</time_frame>
    <description>change in total volume of air expired forcefully</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percent change of six minutes walking distance (6MWD)</measure>
    <time_frame>at 12 weeks after hospital discharge</time_frame>
    <description>distance in meters a subject walk within 6 minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in health related quality of life</measure>
    <time_frame>12 weeks after hospital discharge</time_frame>
    <description>measured by Saint George Respiratory Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in score of shortness of breath</measure>
    <time_frame>12 weeks after hospital discharge</time_frame>
    <description>measure by baseline and transitional dyspnea index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>first day of hospital admission to day of hospital discharge up to 12 weeks</time_frame>
    <description>measured in days of hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital readmission</measure>
    <time_frame>4 weeks after discharge</time_frame>
    <description>admission to hospital after 30 days of discharge due to COPD exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severe COPD exacerbation</measure>
    <time_frame>12 weeks after discharge</time_frame>
    <description>exacerbation of COPD need hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Moderate COPD exacerbation</measure>
    <time_frame>12 weeks after discharge</time_frame>
    <description>exacerbation of COPD need additional treatment as antibiotics and/or steroids</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Aerobika</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group of participants with COPD, hospitalized for severe exacerbation and using the active oscillating positive expiratory pressure device (OPEP). The device is a hand held one. Used mostly in subjects with bronchiectasis for mucus clearing. Estimated number of subjects in this arm is 80. The device has an adjustable resistance which will be set by a health care provider in the study team. The device is to be used three times daily from 10 to 20 minutes according to subject's effort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham device</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Group of participants using the same looking device which is devoid from nebulizer port valve so it is not functioning (sham device). The sham arm is a control arm. It will be used as the active comparator three times daily for 10 to 20 minutes according to subject's effort</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OPEP Aerobika</intervention_name>
    <description>Previous studies of OPEP device shows preliminary benefit in subjects with COPD. No serious adverse events were recorded in previous studies. The device is FDA registered.</description>
    <arm_group_label>Aerobika</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OPEP Aerobika Sham device</intervention_name>
    <description>The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.</description>
    <arm_group_label>Sham device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients, stages 3-4 according to GOLD guidelines 2016, with post bronchodilator&#xD;
             FEV1/FVC &lt; 70% of predicted and FEV1 &lt; 50% with exacerbations necessitates hospital&#xD;
             admission.&#xD;
&#xD;
          -  Smokers or Ex-smokers.&#xD;
&#xD;
          -  Able and willing to provide informed signed consent. Able and understanding the&#xD;
             correct use of the bronchial clearing device.&#xD;
&#xD;
          -  Able to perform effectively spirometry.&#xD;
&#xD;
          -  Able and willing to receive the management plane as indicated including systemic&#xD;
             steroids if seemed necessary.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other obstructive pulmonary diseases or those do not fulfill the criteria of COPD&#xD;
             diagnosis.&#xD;
&#xD;
          -  Nonsmokers.&#xD;
&#xD;
          -  Presence of major comorbidity causing organ dysfunction as cardiac (including severe&#xD;
             pulmonary hypertension), renal, or liver impairment (not including diabetes, arterial&#xD;
             hypertension, or obesity).&#xD;
&#xD;
          -  Presence of lobar pneumonia.&#xD;
&#xD;
          -  Suspicion of bronchogenic malignancy.&#xD;
&#xD;
          -  Any other complication either at admission or during hospital stay as pneumothorax,&#xD;
             pulmonary embolism, myocardial infarction, acute coronary syndrome, cerebrovascular&#xD;
             accidents, ...&#xD;
&#xD;
          -  Patients unable or not willing to provide informed signed consent.&#xD;
&#xD;
          -  Patients unable to use the bronchial clearing device.&#xD;
&#xD;
          -  Patients unable to perform spirometry.&#xD;
&#xD;
          -  Patients unable or not willing to comply to the management plan or the study protocol.&#xD;
&#xD;
          -  Patients receiving regular oral steroids or non-selective beta blockers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vladimir Kushnarev</last_name>
    <role>Study Director</role>
    <affiliation>Trudell Medical International</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hesham H Raafat, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yasser Mostafa, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian W Carlin</last_name>
    <role>Study Director</role>
    <affiliation>West Penn Allegheny Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>March 2, 2022</last_update_submitted>
  <last_update_submitted_qc>March 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Hesham Raafat</investigator_full_name>
    <investigator_title>Ass. Professor of chest medicine</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>acute exacerbation</keyword>
  <keyword>OPEP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03299231
org study id: FMASU P56/2017
nct id: NCT03299231
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Sputum production increases in acute exacerbation of COPD, both in amount and consistency. It
      increases airways obstruction and hence delays improvement and prolongs hospital stay.
      oscillating positive expiratory pressure (OPEP) devices were extensively studied in cystic
      fibrosis and bronchiectasis. Only seldom studied in chronic bronchitis. This study aims to
      measure the effects of mucous clearing device in hospitalized patients with acute
      exacerbation of COPD.
In this study, investigators will investigate the change of objective measurements of lung
      functions and exercise capacity in addition to subjective measures of quality of life.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, Parallel group (1:1), Randomized, double blind, sham controlled, single center.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Randomization carried by a third party not involved in the study.
measure: percent change of Forced expiratory volume in first second (FEV1)
time frame: at 12 weeks after hospital discharge
description: change in volume of air expired forcefully in first second of expiration
measure: percent change of Forced vital capacity (FVC)
time frame: at 12 weeks after hospital discharge
description: change in total volume of air expired forcefully
measure: percent change of six minutes walking distance (6MWD)
time frame: at 12 weeks after hospital discharge
description: distance in meters a subject walk within 6 minutes
measure: change in health related quality of life
time frame: 12 weeks after hospital discharge
description: measured by Saint George Respiratory Questionnaire
measure: change in score of shortness of breath
time frame: 12 weeks after hospital discharge
description: measure by baseline and transitional dyspnea index
measure: hospital stay
time frame: first day of hospital admission to day of hospital discharge up to 12 weeks
description: measured in days of hospital stay
measure: hospital readmission
time frame: 4 weeks after discharge
description: admission to hospital after 30 days of discharge due to COPD exacerbation
measure: severe COPD exacerbation
time frame: 12 weeks after discharge
description: exacerbation of COPD need hospitalization
measure: Moderate COPD exacerbation
time frame: 12 weeks after discharge
description: exacerbation of COPD need additional treatment as antibiotics and/or steroids
arm group label: Aerobika
arm group type: Active Comparator
description: Group of participants with COPD, hospitalized for severe exacerbation and using the active oscillating positive expiratory pressure device (OPEP). The device is a hand held one. Used mostly in subjects with bronchiectasis for mucus clearing. Estimated number of subjects in this arm is 80. The device has an adjustable resistance which will be set by a health care provider in the study team. The device is to be used three times daily from 10 to 20 minutes according to subject's effort.
arm group label: Sham device
arm group type: Sham Comparator
description: Group of participants using the same looking device which is devoid from nebulizer port valve so it is not functioning (sham device). The sham arm is a control arm. It will be used as the active comparator three times daily for 10 to 20 minutes according to subject's effort
intervention type: Device
intervention name: OPEP Aerobika
description: Previous studies of OPEP device shows preliminary benefit in subjects with COPD. No serious adverse events were recorded in previous studies. The device is FDA registered.
arm group label: Aerobika
intervention type: Device
intervention name: OPEP Aerobika Sham device
description: The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.
arm group label: Sham device
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Vladimir Kushnarev
role: Study Director
affiliation: Trudell Medical International
last name: Hesham H Raafat, M.D.
role: Principal Investigator
affiliation: Ain Shams University
last name: Yasser Mostafa, M.D.
role: Study Director
affiliation: Ain Shams University
last name: Brian W Carlin
role: Study Director
affiliation: West Penn Allegheny Health System
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Hesham Raafat
investigator title: Ass. Professor of chest medicine
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No