<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/NCT02201082</url>
  </required_header>
  <id_info>
    <org_study_id>Physionebu</org_study_id>
    <nct_id>NCT02201082</nct_id>
  </id_info>
  <brief_title>Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the optimal time for the nebulization depending on&#xD;
      the respiratory physiotherapy session in cystic fibrosis patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2013</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary excretion of amikacin</measure>
    <time_frame>24h after the nebulization</time_frame>
    <description>Pharmacokinetic study of the urinary excretion of amikacin after nebulization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amikacin concentration into the sputum</measure>
    <time_frame>At the end of the nebulization, an expected average of 20 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Nebulization and airway clearance technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>nebulization combined to airway clearance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nebulization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nebulization</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Airway clearance technique</intervention_name>
    <arm_group_label>Nebulization and airway clearance technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amikacin nebulization</intervention_name>
    <arm_group_label>Nebulization</arm_group_label>
    <arm_group_label>Nebulization and airway clearance technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable cystic fibrosis patients older than 16 y.o.&#xD;
&#xD;
          -  Pseudomonas aeruginosa colonization&#xD;
&#xD;
          -  Hypersecretion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Kidney failure&#xD;
&#xD;
          -  No pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>February 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>August 24, 2015</last_update_submitted>
  <last_update_submitted_qc>August 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2015</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>Cystic Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amikacin</mesh_term>
  </intervention_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/NCT02201082
org study id: Physionebu
nct id: NCT02201082
lead sponsor: 
has dmc: No
The purpose of this study is to determine the optimal time for the nebulization depending on
      the respiratory physiotherapy session in cystic fibrosis patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Urinary excretion of amikacin
time frame: 24h after the nebulization
description: Pharmacokinetic study of the urinary excretion of amikacin after nebulization
measure: Amikacin concentration into the sputum
time frame: At the end of the nebulization, an expected average of 20 minutes
arm group label: Nebulization and airway clearance technique
arm group type: Experimental
description: nebulization combined to airway clearance
arm group label: Nebulization
arm group type: Active Comparator
description: nebulization
intervention type: Procedure
intervention name: Airway clearance technique
arm group label: Nebulization and airway clearance technique
intervention type: Drug
intervention name: Amikacin nebulization
arm group label: Nebulization
arm group label: Nebulization and airway clearance technique
criteria: 
gender: All
minimum age: 16 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Amikacin