<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/NCT03816722</url>
  </required_header>
  <id_info>
    <org_study_id>N-20180070</org_study_id>
    <nct_id>NCT03816722</nct_id>
  </id_info>
  <brief_title>High Flow in Interstitial Lung Disease</brief_title>
  <acronym>HiFloILD</acronym>
  <official_title>The Effect of High Flow, Nasal Cannula Delivered Air in Patients With Interstitial Lung Disease - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fisher and Paykel Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Aalborg University Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, 6 week cross-over study on the effect of High flow nasal cannula&#xD;
      (HFNC) delivered air in patients with interstitial lung disease (ILD), in need of ambulatory&#xD;
      oxygen therapy.&#xD;
&#xD;
      Primary outcome:&#xD;
&#xD;
      To investigate intra-personal differences in 6MWT, as well as SO2 and BORG score at the end&#xD;
      of the 6MWT, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences&#xD;
      in SGRQ at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in&#xD;
      quality of sleep, using the Richards-Campbell sleep questionnaire (RCSQ) at baseline, at 6&#xD;
      weeks and 12 weeks To investigate intra-personal differences in IC, at baseline, at 6 weeks&#xD;
      and 12 weeks&#xD;
&#xD;
      Secondary outcome:&#xD;
&#xD;
      To investigate intra-personal differences in FVC, at baseline, at 6 weeks and 12 weeks To&#xD;
      investigate intra-personal differences in DLCO at baseline, at 6 weeks and 12 weeks To&#xD;
      investigate intra-personal differences in mMRC-score at baseline, at 6 weeks and 12 weeks&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this pilot study we wish to investigate whether treatment with HFNC, delivered by MyAirvo2&#xD;
      (Fisher&amp;Paykel, Auckland, New Zealand) in patients with interstitial lung disease (ILD) in&#xD;
      need of ambulatory oxygen therapy (AOT).&#xD;
&#xD;
      Ten patients will be recruited from the outpatient clinic at Department of Respiratory&#xD;
      Diseases, Aalborg University Hospital.&#xD;
&#xD;
      The study is carried out as a cross over study, randomizing 5 patients to intitially 6 weeks'&#xD;
      HFNC treatment as add on to the patients' personalized usual care followed by 6 weeks&#xD;
      observation on usual care and 5 patients to 6 weeks' observation on the patients'&#xD;
      personalized usual care, followed by 6 weeks with HFNC as add on to usual care.&#xD;
&#xD;
      At inclusion patients' background information will be registered and patients will be&#xD;
      examined with body plethysmography, registering TLC, FVC, RV and IC, as well as DLCO.&#xD;
      Furthermore, a 6MWT will be performed, monitoring peripheral oxygen saturation (SO2)and BORG&#xD;
      score at the beginning and the end of the procedure as well as analysis of arterial blood&#xD;
      gasses (PaO2, PaCO2) at rest. In addition the modified Medical Research Council (mMRC)-&#xD;
      score; the Richards-Campbell Sleep Questionaire (RCSQ) and the St. George Respiratory&#xD;
      Questionaire (SGRQ) will be carried out at baseline. Following this, patients will be&#xD;
      randomized to either usual care or usual care plus HFNC, recommended flow 30 liters/minute,&#xD;
      recommended temperature 37o Celsius, recommended use 8 hours/day, preferably at night. After&#xD;
      6 weeks body plethysmography, 6MWT, mMRC, SGRQ, RCSQ and arterial blood gas analysis will be&#xD;
      repeated and following this, treatment will cross over; as such, patients initially in the&#xD;
      usual care arm will be treated with HFNC as add on according to the recommendations stated&#xD;
      above and the previous HFNC treated group will be referred to usual care for the following 6&#xD;
      weeks. At the end of the study period (t=12 weeks), body plethysmography, 6MWT, mMRC, RCSQ,&#xD;
      SGRQ and arterial puncture will be repeated in all patients as well as background information&#xD;
      will be revisited to note any changes.&#xD;
&#xD;
      Should the patient reach chronic respiratory failure (saturation at rest &lt; 88%) during the&#xD;
      study period, patients will remain in study and the airflow during HFNC be oxygenated with&#xD;
      whatever amount of oxygen is required to reach saturation &gt;88% during High Flow treatment.&#xD;
&#xD;
      Equipment:&#xD;
&#xD;
      Heated, humidified, air will be delivered to the patients by MyAirvo 2 (Fisher&amp;Paykel,&#xD;
      Auckland, New Zealand). Patients will be treated with an intended flow of 30 L/min, intended&#xD;
      use 8 hours per day, preferably nocturnal use. Should patients not tolerate the recommended&#xD;
      flow, changes in flow are allowed. The Airvo2 device will be delivered and serviced in the&#xD;
      patients' homes by VitalAire. Vitalaire will do readings of actual use on the device. At the&#xD;
      end of the study, all patients will be offered continuous treatment with the device if so&#xD;
      desired.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 3, 2021</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>Prospective, unblinded cross over study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>As blinding of high flow treatment in not possible this is an open label study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>6 minute walk test</measure>
    <time_frame>change between 6 and 12 weeks</time_frame>
    <description>walking distance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SO2</measure>
    <time_frame>change between 6 and 12 weeks</time_frame>
    <description>oxygen saturation of the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>modified BORG score</measure>
    <time_frame>6 and 12 weeks</time_frame>
    <description>score of dyspnea, ranging 0-10 where 0 is no dyspnea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>St George Respiratory Questionaire (SGRQ)</measure>
    <time_frame>change between 6 and 12 weeks</time_frame>
    <description>respiratory quality of life questionnaire, score with 20 questions all weighted in the final evaluation of the score. A change of 4 points is clinically relevant; a change of -4 an amelioration of quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Richards-Campbell's sleep questionnaire (RCSQ)</measure>
    <time_frame>change between 6 and 12 weeks</time_frame>
    <description>Quality of sleep questionnaire, based on 5 domains, evaluated individually by Visual Analog Scores(0-100), where 0 is the worst, 100 is the best outcome. All scores are equally weighted in the final score. The final, combined score is averaged, and expressed as a percentage of the total score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>inspiratory capacity</measure>
    <time_frame>change between 6 and 12 weeks</time_frame>
    <description>lung function measure (L, %)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Forced Vital Capacity</measure>
    <time_frame>change between 6 and 12 weeks</time_frame>
    <description>lung function measure (L, %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diffusion capacity of the lung for carbon monoxide (DLCO)</measure>
    <time_frame>change between 6 and 12 weeks</time_frame>
    <description>diffusion capacity measure, (% of expected value)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Medical Research Council score (mMRC-score)</measure>
    <time_frame>change between 6 and 12 weeks</time_frame>
    <description>dyspnea-score, scoring from 0-4 points</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Lung Diseases, Interstitial</condition>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients starting the cross over with 6 weeks of high flow treatment with Airvo2 in addition to usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients starting the cross over in the usual care Group but after 6 weeks receiving High Flow treatment with Airvo2</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Airvo2</intervention_name>
    <description>Treatment with HighFlow through the Airvo2 device, 8 hours per day</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>High flow treatment is investigated as an add on treatment to the personalized care already prescribed to the patients. As patients with interstitial lung disease very often demand very different treatment set ups treatment will vary in the individual patients. All will, however, be treated with ambulatory oxygen. &quot;Usual care&quot; will be unaltered a month before inclusion in the study in each of the individual patients</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>intervention</arm_group_label>
    <other_name>Ambulatory oxygen therapy, personalised medicine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Patient diagnosed with interstitial lung disease&#xD;
&#xD;
          -  Capable of understanding oral and written information and giving informed consent&#xD;
&#xD;
          -  Newly diagnosed with need of oxygen during physical activity (SO2 &lt;88%).&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Pneumonia or exacerbation of ILD &lt; 6 weeks prior to inclusion&#xD;
&#xD;
          -  Other terminal disease than ILD and life expectancy &lt; 3 months&#xD;
&#xD;
          -  Patients not capable of understanding and accepting written or verbal information&#xD;
&#xD;
          -  Patients with in need of continuous oxygen treatment at inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulla M Weinreich, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aalborg University Hospital, Mølleparkvej 4, 9100 Aalborg, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University Hospital</investigator_affiliation>
    <investigator_full_name>Ulla Møller Weinreich</investigator_full_name>
    <investigator_title>Principal Investgator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There a no IPD sharing plans at present</ipd_description>
  </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/NCT03816722
org study id: N-20180070
nct id: NCT03816722
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a prospective, 6 week cross-over study on the effect of High flow nasal cannula
      (HFNC) delivered air in patients with interstitial lung disease (ILD), in need of ambulatory
      oxygen therapy.

      Primary outcome:

      To investigate intra-personal differences in 6MWT, as well as SO2 and BORG score at the end
      of the 6MWT, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences
      in SGRQ at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in
      quality of sleep, using the Richards-Campbell sleep questionnaire (RCSQ) at baseline, at 6
      weeks and 12 weeks To investigate intra-personal differences in IC, at baseline, at 6 weeks
      and 12 weeks

      Secondary outcome:

      To investigate intra-personal differences in FVC, at baseline, at 6 weeks and 12 weeks To
      investigate intra-personal differences in DLCO at baseline, at 6 weeks and 12 weeks To
      investigate intra-personal differences in mMRC-score at baseline, at 6 weeks and 12 weeks
In this pilot study we wish to investigate whether treatment with HFNC, delivered by MyAirvo2
      (Fisher&Paykel, Auckland, New Zealand) in patients with interstitial lung disease (ILD) in
      need of ambulatory oxygen therapy (AOT).

      Ten patients will be recruited from the outpatient clinic at Department of Respiratory
      Diseases, Aalborg University Hospital.

      The study is carried out as a cross over study, randomizing 5 patients to intitially 6 weeks'
      HFNC treatment as add on to the patients' personalized usual care followed by 6 weeks
      observation on usual care and 5 patients to 6 weeks' observation on the patients'
      personalized usual care, followed by 6 weeks with HFNC as add on to usual care.

      At inclusion patients' background information will be registered and patients will be
      examined with body plethysmography, registering TLC, FVC, RV and IC, as well as DLCO.
      Furthermore, a 6MWT will be performed, monitoring peripheral oxygen saturation (SO2)and BORG
      score at the beginning and the end of the procedure as well as analysis of arterial blood
      gasses (PaO2, PaCO2) at rest. In addition the modified Medical Research Council (mMRC)-
      score; the Richards-Campbell Sleep Questionaire (RCSQ) and the St. George Respiratory
      Questionaire (SGRQ) will be carried out at baseline. Following this, patients will be
      randomized to either usual care or usual care plus HFNC, recommended flow 30 liters/minute,
      recommended temperature 37o Celsius, recommended use 8 hours/day, preferably at night. After
      6 weeks body plethysmography, 6MWT, mMRC, SGRQ, RCSQ and arterial blood gas analysis will be
      repeated and following this, treatment will cross over; as such, patients initially in the
      usual care arm will be treated with HFNC as add on according to the recommendations stated
      above and the previous HFNC treated group will be referred to usual care for the following 6
      weeks. At the end of the study period (t=12 weeks), body plethysmography, 6MWT, mMRC, RCSQ,
      SGRQ and arterial puncture will be repeated in all patients as well as background information
      will be revisited to note any changes.

      Should the patient reach chronic respiratory failure (saturation at rest < 88%) during the
      study period, patients will remain in study and the airflow during HFNC be oxygenated with
      whatever amount of oxygen is required to reach saturation >88% during High Flow treatment.

      Equipment:

      Heated, humidified, air will be delivered to the patients by MyAirvo 2 (Fisher&Paykel,
      Auckland, New Zealand). Patients will be treated with an intended flow of 30 L/min, intended
      use 8 hours per day, preferably nocturnal use. Should patients not tolerate the recommended
      flow, changes in flow are allowed. The Airvo2 device will be delivered and serviced in the
      patients' homes by VitalAire. Vitalaire will do readings of actual use on the device. At the
      end of the study, all patients will be offered continuous treatment with the device if so
      desired.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Prospective, unblinded cross over study
primary purpose: Supportive Care
masking: None (Open Label)
masking description: As blinding of high flow treatment in not possible this is an open label study
measure: 6 minute walk test
time frame: change between 6 and 12 weeks
description: walking distance
measure: SO2
time frame: change between 6 and 12 weeks
description: oxygen saturation of the blood
measure: modified BORG score
time frame: 6 and 12 weeks
description: score of dyspnea, ranging 0-10 where 0 is no dyspnea
measure: St George Respiratory Questionaire (SGRQ)
time frame: change between 6 and 12 weeks
description: respiratory quality of life questionnaire, score with 20 questions all weighted in the final evaluation of the score. A change of 4 points is clinically relevant; a change of -4 an amelioration of quality of life
measure: Richards-Campbell's sleep questionnaire (RCSQ)
time frame: change between 6 and 12 weeks
description: Quality of sleep questionnaire, based on 5 domains, evaluated individually by Visual Analog Scores(0-100), where 0 is the worst, 100 is the best outcome. All scores are equally weighted in the final score. The final, combined score is averaged, and expressed as a percentage of the total score
measure: inspiratory capacity
time frame: change between 6 and 12 weeks
description: lung function measure (L, %)
measure: Forced Vital Capacity
time frame: change between 6 and 12 weeks
description: lung function measure (L, %)
measure: diffusion capacity of the lung for carbon monoxide (DLCO)
time frame: change between 6 and 12 weeks
description: diffusion capacity measure, (% of expected value)
measure: modified Medical Research Council score (mMRC-score)
time frame: change between 6 and 12 weeks
description: dyspnea-score, scoring from 0-4 points
arm group label: intervention
arm group type: Experimental
description: Patients starting the cross over with 6 weeks of high flow treatment with Airvo2 in addition to usual care
arm group label: control
arm group type: Experimental
description: Patients starting the cross over in the usual care Group but after 6 weeks receiving High Flow treatment with Airvo2
intervention type: Device
intervention name: Airvo2
description: Treatment with HighFlow through the Airvo2 device, 8 hours per day
arm group label: control
arm group label: intervention
intervention type: Other
intervention name: Usual care
description: High flow treatment is investigated as an add on treatment to the personalized care already prescribed to the patients. As patients with interstitial lung disease very often demand very different treatment set ups treatment will vary in the individual patients. All will, however, be treated with ambulatory oxygen. "Usual care" will be unaltered a month before inclusion in the study in each of the individual patients
arm group label: control
arm group label: intervention
other name: Ambulatory oxygen therapy, personalised medicine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulla M Weinreich, MD, PhD
role: Principal Investigator
affiliation: Aalborg University Hospital, Mølleparkvej 4, 9100 Aalborg, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University Hospital
investigator full name: Ulla Møller Weinreich
investigator title: Principal Investgator
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
sharing ipd: No
ipd description: There a no IPD sharing plans at present