<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/NCT01718067</url>
  </required_header>
  <id_info>
    <org_study_id>2793</org_study_id>
    <nct_id>NCT01718067</nct_id>
  </id_info>
  <brief_title>Efficacy of Vakum Technology in Patients With Chronic Hypersecretion</brief_title>
  <official_title>Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Villa Pineta Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Villa Pineta Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist&#xD;
      patients with chronic retention of secretions. VAKÜM technology has been recently developed&#xD;
      with the aim to improve the respiratory condition in hypersecretive patients suffering from&#xD;
      chronic respiratory diseases.&#xD;
&#xD;
      The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients with&#xD;
      hypersecretion, and chronic respiratory diseases a clinical trial has been designed.&#xD;
&#xD;
      Patients with chronic respiratory diseases, hypersecretion (sputum production &gt;30 mL/die),&#xD;
      and reduced cough efficiency (Peak Cough Expiratory Flow &gt; 150 and &lt; 300 L*min-1) referred to&#xD;
      standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind&#xD;
      multicentre randomized trial with consecutive recruitment. Following a preliminary run-in&#xD;
      period, group comparison will be made between Intervention group using VAKÜM system (Free&#xD;
      Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group&#xD;
      using manual ELTGOL alone over 10 daily sessions.&#xD;
&#xD;
      Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of&#xD;
      life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale), sputum&#xD;
      volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory air&#xD;
      flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary&#xD;
      outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point&#xD;
      (SD 5) group difference change in the primary outcome at the end of the study period as&#xD;
      significant at the 0.05 level, at least 42 patients per group are needed. The minimum target&#xD;
      sample size will be then fixed at 50 patients per group.&#xD;
&#xD;
      An higher and faster significant reduction of the perceived dyspnea is supposed in the&#xD;
      Intervention group. Additional benefits among the secondary outcomes are also hypothesised in&#xD;
      the same group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">April 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in perceived dyspnea</measure>
    <time_frame>Baseline and 10 days</time_frame>
    <description>Visual Analogic Scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in peak expiratory air flows</measure>
    <time_frame>Baseline and 10 days</time_frame>
    <description>Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in arterial blood gases exchanges</measure>
    <time_frame>Baseline and 10 days</time_frame>
    <description>PaO2, PaCO2, SatO2, pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in spirometric lung volumes</measure>
    <time_frame>Baseline and 10 days</time_frame>
    <description>Static and dynamic lung volumes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory muscle strength</measure>
    <time_frame>Baseline and 10 days</time_frame>
    <description>Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sputum volume and characteristics</measure>
    <time_frame>Daily over 10 days</time_frame>
    <description>Volume, Density (D) and Purulence (P) (D and P assessed on a semi-quantitative 3-point scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline and 10 days</time_frame>
    <description>Quality of life questionnaires (CAT, MRF 28)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Bronchitis/Bronchiectasis</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Vakum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional manual ELTGOL technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VAKÜM system</intervention_name>
    <description>15 minutes, twice a day.</description>
    <arm_group_label>Vakum</arm_group_label>
    <other_name>Free Aspire, MPR, Legnano-I</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional manual ELTGOL technique</intervention_name>
    <description>20 minutes twice a day</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Vakum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with chronic respiratory diseases&#xD;
&#xD;
          -  hypersecretion condition(sputum production &gt;30 mL/die)&#xD;
&#xD;
          -  reduced cough efficiency (Peak Cough Expiratory Flow &gt; 150 and &lt; 300 L*min- 1)&#xD;
&#xD;
          -  patients admitted to standard pulmonary rehabilitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not able to use the device&#xD;
&#xD;
          -  concomitant cardiovascular or neoplastic diseases&#xD;
&#xD;
          -  utilization of Non Invasive Ventilation&#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>Enrico M Clini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Modena Reggio Emilia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Enrico M Clini, Prof.</last_name>
    <email>enrico.clini@unimore.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Villa Pineta Hospital</name>
      <address>
        <city>Modena</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Enrico M Clini, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>December 9, 2014</last_update_submitted>
  <last_update_submitted_qc>December 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Villa Pineta Hospital</investigator_affiliation>
    <investigator_full_name>Prof. Clini Enrico</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Chest physiotherapy</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Chronic respiratory diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Bronchitis, Chronic</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Bronchiectasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01718067
org study id: 2793
nct id: NCT01718067
lead sponsor: 
has dmc: No
Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist
      patients with chronic retention of secretions. VAKÜM technology has been recently developed
      with the aim to improve the respiratory condition in hypersecretive patients suffering from
      chronic respiratory diseases.

      The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients with
      hypersecretion, and chronic respiratory diseases a clinical trial has been designed.

      Patients with chronic respiratory diseases, hypersecretion (sputum production >30 mL/die),
      and reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min-1) referred to
      standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind
      multicentre randomized trial with consecutive recruitment. Following a preliminary run-in
      period, group comparison will be made between Intervention group using VAKÜM system (Free
      Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group
      using manual ELTGOL alone over 10 daily sessions.

      Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of
      life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale), sputum
      volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory air
      flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary
      outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point
      (SD 5) group difference change in the primary outcome at the end of the study period as
      significant at the 0.05 level, at least 42 patients per group are needed. The minimum target
      sample size will be then fixed at 50 patients per group.

      An higher and faster significant reduction of the perceived dyspnea is supposed in the
      Intervention group. Additional benefits among the secondary outcomes are also hypothesised in
      the same group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in perceived dyspnea
time frame: Baseline and 10 days
description: Visual Analogic Scale (VAS)
measure: Change in peak expiratory air flows
time frame: Baseline and 10 days
description: Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)
measure: Change in arterial blood gases exchanges
time frame: Baseline and 10 days
description: PaO2, PaCO2, SatO2, pH
measure: Change in spirometric lung volumes
time frame: Baseline and 10 days
description: Static and dynamic lung volumes
measure: Change in respiratory muscle strength
time frame: Baseline and 10 days
description: Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)
measure: Change in sputum volume and characteristics
time frame: Daily over 10 days
description: Volume, Density (D) and Purulence (P) (D and P assessed on a semi-quantitative 3-point scale)
measure: Change in quality of life
time frame: Baseline and 10 days
description: Quality of life questionnaires (CAT, MRF 28)
arm group label: Vakum
arm group type: Experimental
description: VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique
arm group label: Control
arm group type: Active Comparator
description: conventional manual ELTGOL technique
intervention type: Device
intervention name: VAKÜM system
description: 15 minutes, twice a day.
arm group label: Vakum
other name: Free Aspire, MPR, Legnano-I
intervention type: Other
intervention name: conventional manual ELTGOL technique
description: 20 minutes twice a day
arm group label: Control
arm group label: Vakum
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Enrico M Clini, MD
role: Principal Investigator
affiliation: University of Modena Reggio Emilia
last name: Enrico M Clini, Prof.
email: enrico.clini@unimore.it
facility: 
status: Recruiting
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Villa Pineta Hospital
investigator full name: Prof. Clini Enrico
investigator title: Prof.
mesh term: Bronchitis
mesh term: Bronchitis, Chronic
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Bronchiectasis