<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/NCT03760120</url>
  </required_header>
  <id_info>
    <org_study_id>2291</org_study_id>
    <nct_id>NCT03760120</nct_id>
  </id_info>
  <brief_title>Short-term Effects of Physiotherapy on LCI</brief_title>
  <acronym>SPICy</acronym>
  <official_title>Short-term Effects of Positive Expiratory Pressure Mask on Ventilation Inhomogeneity in Children and Adolescents With Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although some studies have brought some evidences about the efficacy of positive expiratory&#xD;
      pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly&#xD;
      understood what is the contribution of this technique in modifying peripheral ventilation&#xD;
      inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).&#xD;
&#xD;
      The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in&#xD;
      children and adolescents, with moderate to normal CF lung disease by the change in acinar&#xD;
      airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived&#xD;
      from nitrogen multiple-breath washout test (N2MBW).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask.&#xD;
&#xD;
      Standard Operating Procedures used for evaluating CF lung disease and ventilation&#xD;
      inhomogeneity.&#xD;
&#xD;
      Sample size: Based on preliminary data collected on seven subjects who performed nitrogen&#xD;
      multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin,&#xD;
      the study requires a sample size of 18 subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2016</start_date>
  <completion_date type="Actual">December 2022</completion_date>
  <primary_completion_date type="Actual">August 2022</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>
    <intervention_model_description>Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Technicians performing multiple-breath washout tests are blinded to treatment allocation; physiotherapists performing the treatment are blinded to multiple breath washout results; patients are blinded to the purpose of the study; the statistician will be blind to treatment allocation together with outcome assessors.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of PEP-MASK on ventilation heterogeneity (Sacin)</measure>
    <time_frame>Right after intervention/sham procedure</time_frame>
    <description>Acinar airways (Sacin) mean difference between treatments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of PEP-MASK on ventilation heterogeneity (Scond)</measure>
    <time_frame>Right after intervention/sham procedure</time_frame>
    <description>Conductive airways (Scond) mean difference between treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of PEP-MASK on ventilation heterogeneity (LCI)</measure>
    <time_frame>Right after intervention/sham procedure</time_frame>
    <description>Ventilation heterogeneity (LCI) mean difference between treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sputum weight</measure>
    <time_frame>From the beginning to the end of each intervention/sham procedure</time_frame>
    <description>Sputum weight (grams) will be collected throughout the active or sham interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>From the beginning to the end of each intervention/sham procedure</time_frame>
    <description>Oxygen saturation (SpO2) will be monitored throughout the active or sham interventions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>PEP standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PEP sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEP-MASK</intervention_name>
    <arm_group_label>PEP sham</arm_group_label>
    <arm_group_label>PEP standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CF diagnosis&#xD;
&#xD;
          -  Patients hospitalized for a scheduled intravenous antibiotics cycle and regularly&#xD;
             followed-up by the CF Centre&#xD;
&#xD;
          -  ≥ 15 kilograms&#xD;
&#xD;
          -  FEV1 ≥ 40%predicted&#xD;
&#xD;
          -  Ability to perform NMBW test&#xD;
&#xD;
          -  Ability to perform spirometry&#xD;
&#xD;
          -  Willing to adhere to protocol procedures&#xD;
&#xD;
          -  Patients in treatment with PEP-MASK&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pulmonary Exacerbation within two last week&#xD;
&#xD;
          -  Burkholderia cepacia infection&#xD;
&#xD;
          -  Patients in lung transplantation waiting list&#xD;
&#xD;
          -  Patients undergoing non invasive mechanical ventilation or oxygen therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carla Colombo</last_name>
    <role>Study Director</role>
    <affiliation>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Meyer</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Regionale di Riferimento Fibrosi Cistica</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.mbwtraining.com/ECFS_MBW_SOP.pdf</url>
    <description>Standard Operating Procedures LCI</description>
  </link>
  <reference>
    <citation>Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.</citation>
    <PMID>16055882</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>December 28, 2022</last_update_submitted>
  <last_update_submitted_qc>December 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physiotherapy</keyword>
  <keyword>pulmonary function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03760120
org study id: 2291
nct id: NCT03760120
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although some studies have brought some evidences about the efficacy of positive expiratory
      pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly
      understood what is the contribution of this technique in modifying peripheral ventilation
      inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).

      The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in
      children and adolescents, with moderate to normal CF lung disease by the change in acinar
      airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived
      from nitrogen multiple-breath washout test (N2MBW).
Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask.

      Standard Operating Procedures used for evaluating CF lung disease and ventilation
      inhomogeneity.

      Sample size: Based on preliminary data collected on seven subjects who performed nitrogen
      multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin,
      the study requires a sample size of 18 subjects.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Technicians performing multiple-breath washout tests are blinded to treatment allocation; physiotherapists performing the treatment are blinded to multiple breath washout results; patients are blinded to the purpose of the study; the statistician will be blind to treatment allocation together with outcome assessors.
measure: Effect of PEP-MASK on ventilation heterogeneity (Sacin)
time frame: Right after intervention/sham procedure
description: Acinar airways (Sacin) mean difference between treatments
measure: Effect of PEP-MASK on ventilation heterogeneity (Scond)
time frame: Right after intervention/sham procedure
description: Conductive airways (Scond) mean difference between treatments
measure: Effect of PEP-MASK on ventilation heterogeneity (LCI)
time frame: Right after intervention/sham procedure
description: Ventilation heterogeneity (LCI) mean difference between treatments
measure: Sputum weight
time frame: From the beginning to the end of each intervention/sham procedure
description: Sputum weight (grams) will be collected throughout the active or sham interventions
measure: Oxygen saturation
time frame: From the beginning to the end of each intervention/sham procedure
description: Oxygen saturation (SpO2) will be monitored throughout the active or sham interventions
arm group label: PEP standard
arm group type: Active Comparator
arm group label: PEP sham
arm group type: Sham Comparator
intervention type: Device
intervention name: PEP-MASK
arm group label: PEP sham
arm group label: PEP standard
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Carla Colombo
role: Study Director
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
facility: 
facility: 
country: Italy
url: http://www.mbwtraining.com/ECFS_MBW_SOP.pdf
description: Standard Operating Procedures LCI
citation: Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PMID: 16055882
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: Undecided