<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/NCT02261987</url>
  </required_header>
  <id_info>
    <org_study_id>FR_FQ- 013</org_study_id>
    <nct_id>NCT02261987</nct_id>
  </id_info>
  <brief_title>Resistive Inspiratory Manoeuvre as Airway Clearance Technique in Cystic Fibrosis</brief_title>
  <official_title>Role of Resistive Inspiratory Manoeuvres During Bronchial Drainage Session in Cystic Fibrosis: a Randomized Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad San Jorge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cystic Fibrosis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad San Jorge</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed&#xD;
      previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus&#xD;
      clearance during a typical bronchial drainage session in adults, stable CF patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a multicenter study. 4 different Spain Cystic Fibrosis Foundations are included in the&#xD;
      study (Madrid, Valencia, Murcia and Aragón). All patients will perform three different arms&#xD;
      of treatment in a crossover randomization. Each arm of treatment will be apply only in one&#xD;
      session. The wash-out period will be one week. Before starting the trial, all patients will&#xD;
      perform a control session without any intervention, only the outcome measures will be assess.&#xD;
&#xD;
      During the study period the patients' pharmacological treatment remained unchanged&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wet sputum production</measure>
    <time_frame>24 hours</time_frame>
    <description>24h wet sputum production (g) after bronchial drainage session</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wet sputum production</measure>
    <time_frame>30 minutes</time_frame>
    <description>Wet sputum production (g) during bronchial drainage session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Computerized respiratory sounds</measure>
    <time_frame>30 minutes</time_frame>
    <description>Adventitous respiratory sounds: crackles and wheezes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function (simply spirometry)</measure>
    <time_frame>30 minutes</time_frame>
    <description>Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients´ perception</measure>
    <time_frame>30 minutes</time_frame>
    <description>Visual analogical scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pulse-oximetry, heart rate and dyspnea</measure>
    <time_frame>30 minutes</time_frame>
    <description>Safety and tolerability of session</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Autogenic drainage (AD)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistive inspiratory manoeuvre (RIM)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will perform the repetitive inspiratory manoeuvers by breathing through a fixed resistance (Power Breathe device, model KH1) . Each session will comprise to cycles of 5 inspiratory breaths (60% of maximal inspiratory pressure). Patients will be stay in both lateral decubitus position (15 min per side).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistive inspiratory manoeuvre+autogenic drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>First, patients will perform the resistive inspiratory manoeuvre during 10 minutes (5 min per side). Right after, patients will perform the autogenic drainage during 20 minutes.The instructions will be similar to described previously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autogenic drainage (AD)</intervention_name>
    <description>It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.</description>
    <arm_group_label>Autogenic drainage (AD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistive inspiratory manoeuvre (RIM)</intervention_name>
    <description>It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.</description>
    <arm_group_label>Resistive inspiratory manoeuvre (RIM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistive inspiratory manoeuvre+autogenic drainage</intervention_name>
    <description>It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.</description>
    <arm_group_label>Resistive inspiratory manoeuvre+autogenic drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium&gt;70 mmol/l or&#xD;
             sweat chloride of&gt;60 mmol/l)&#xD;
&#xD;
          -  Clinically stable at time of study entry (defined as no requirement for antibiotics or&#xD;
             change in respiratory medication in the preceding 4 wk);&#xD;
&#xD;
          -  Chronic sputum production, at least ≥ 15 ml /24h&#xD;
&#xD;
          -  Familiar and trained in the use of autogenic drainage technique (at least 6 months)&#xD;
             and resistive inspiratory manoeuvre (at least three previous sessions)&#xD;
&#xD;
          -  To be able to provide written, informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lung function: Forced expiratory volume in 1 second &lt; 30 % pred . ; Forced vital&#xD;
             capacity &lt; 40 % pred.&#xD;
&#xD;
          -  Active haemoptysis during the previous month&#xD;
&#xD;
          -  Supplemental oxygen or non-invasive ventilation (NIV)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beatriz Herrero, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad San Jorge</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cystic Fibrosis Association</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cystic Fibrosis Association</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cystic Fibrosis Association</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad San Jorge</name>
      <address>
        <city>Zaragoza</city>
        <zip>50830</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Chatham K, Ionescu AA, Nixon LS, Shale DJ. A short-term comparison of two methods of sputum expectoration in cystic fibrosis. Eur Respir J. 2004 Mar;23(3):435-9. doi: 10.1183/09031936.04.00084904.</citation>
    <PMID>15065835</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>November 11, 2016</last_update_submitted>
  <last_update_submitted_qc>November 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autogenic drainage</keyword>
  <keyword>Resistive inspiratory manoeuvre</keyword>
  <keyword>Computerized respiratory sounds</keyword>
  <keyword>Airway clearance techniques</keyword>
  <keyword>Mucus clearances</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Fibrosis</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/NCT02261987
org study id: FR_FQ- 013
nct id: NCT02261987
lead sponsor: 
collaborator: 
has dmc: Yes
This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed
      previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus
      clearance during a typical bronchial drainage session in adults, stable CF patients.
It is a multicenter study. 4 different Spain Cystic Fibrosis Foundations are included in the
      study (Madrid, Valencia, Murcia and Aragón). All patients will perform three different arms
      of treatment in a crossover randomization. Each arm of treatment will be apply only in one
      session. The wash-out period will be one week. Before starting the trial, all patients will
      perform a control session without any intervention, only the outcome measures will be assess.

      During the study period the patients' pharmacological treatment remained unchanged
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Wet sputum production
time frame: 24 hours
description: 24h wet sputum production (g) after bronchial drainage session
measure: Wet sputum production
time frame: 30 minutes
description: Wet sputum production (g) during bronchial drainage session
measure: Computerized respiratory sounds
time frame: 30 minutes
description: Adventitous respiratory sounds: crackles and wheezes
measure: Lung function (simply spirometry)
time frame: 30 minutes
description: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
measure: Patients´ perception
time frame: 30 minutes
description: Visual analogical scale
measure: Pulse-oximetry, heart rate and dyspnea
time frame: 30 minutes
description: Safety and tolerability of session
arm group label: Autogenic drainage (AD)
arm group type: Active Comparator
description: Patients will perform the autogenic drainage technique following the Chevallier and Agostini recommendations.
arm group label: Resistive inspiratory manoeuvre (RIM)
arm group type: Active Comparator
description: Patients will perform the repetitive inspiratory manoeuvers by breathing through a fixed resistance (Power Breathe device, model KH1) . Each session will comprise to cycles of 5 inspiratory breaths (60% of maximal inspiratory pressure). Patients will be stay in both lateral decubitus position (15 min per side).
arm group label: Resistive inspiratory manoeuvre+autogenic drainage
arm group type: Active Comparator
description: First, patients will perform the resistive inspiratory manoeuvre during 10 minutes (5 min per side). Right after, patients will perform the autogenic drainage during 20 minutes.The instructions will be similar to described previously.
intervention type: Other
intervention name: Autogenic drainage (AD)
description: It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
arm group label: Autogenic drainage (AD)
intervention type: Other
intervention name: Resistive inspiratory manoeuvre (RIM)
description: It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
arm group label: Resistive inspiratory manoeuvre (RIM)
intervention type: Other
intervention name: Resistive inspiratory manoeuvre+autogenic drainage
description: It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
arm group label: Resistive inspiratory manoeuvre+autogenic drainage
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Beatriz Herrero, Msc
role: Principal Investigator
affiliation: Universidad San Jorge
facility: 
facility: 
facility: 
facility: 
country: Spain
citation: Chatham K, Ionescu AA, Nixon LS, Shale DJ. A short-term comparison of two methods of sputum expectoration in cystic fibrosis. Eur Respir J. 2004 Mar;23(3):435-9. doi: 10.1183/09031936.04.00084904.
PMID: 15065835
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Respiratory Aspiration
mesh term: Fibrosis