<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/NCT03287713</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-OXI-2017-18</org_study_id>
    <nct_id>NCT03287713</nct_id>
  </id_info>
  <brief_title>Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?</brief_title>
  <official_title>Can Nasal High-Flow Oxygen Therapy Improve Oxygenation During Exercise, Optimizing Benefits of Pulmonary Rehabilitation in Patients With Interstitial Lung Disease (ILD) With Exercise Desaturation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objectives: 1.- To compare the level of oxygenation achieved during muscular training with&#xD;
      conventional oxygen systems (nasal cannulas) versus nasal High-flow oxygen therapy. 2.-To&#xD;
      compare benefits achieved with both systems, in terms of: level of exercise during training;&#xD;
      effort tolerance in the 6 minutes walking test (6MWT); improvement of dyspnoea and&#xD;
      Health-related quality of life (HRQoL). And analyse the effects of nasal High-flow oxygen&#xD;
      therapy on the acute exercise in a subgroup of patients.&#xD;
&#xD;
      Method: Multicentric randomized clinical trial. Patients with ILD in fibrotic phase who&#xD;
      present oxygen desaturation during 6MWT (SpO2 mean ≤ 85%) will be included consecutively.&#xD;
      Will be randomized in two groups: ILD patients with conventional oxygen (EPIDOC) and ILD&#xD;
      patients with nasal High-Flow oxygen therapy (EPIDOAF). Both groups will perform a Pulmonary&#xD;
      Rehabilitation Program. Oxygen will be titrated respectively to flow and FiO2 needed to&#xD;
      maintain SpO2 ≥ 90% during training with both systems. Evaluation measures: SpO2 during&#xD;
      training in both groups; dyspnoea (mMRC scale and CRQ dyspnoea); exercise capacity (6MWT) and&#xD;
      HRQoL (self- administered KBILD questionnaire and SF36). In a subgroup of patients will be&#xD;
      compared time of endurance exercise to evaluate the effects of nasal high-flow oxygen therapy&#xD;
      in the acute exercise.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation</measure>
    <time_frame>8 weeks</time_frame>
    <description>To compare the level of oxygenation (in SatO2 %) achieved by conventional oxygen therapy and nasal high flow oxygen therapy during muscular training program in patients with ILD measured by pulseoxymetry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyspnoea (benefits in borg scale) DURING effort.</measure>
    <time_frame>8 weeks</time_frame>
    <description>To compare the benefits in dyspnoea achieved by both systems in terms of Effort level during the training period measured by Borg Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effort capacity (Benefits in terms of meters walked in the 6mwt).</measure>
    <time_frame>8 weeks</time_frame>
    <description>To compare the benefits achieved by both systems in terms of Effort tolerance after PR program, evaluated with the 6 minut waking test (6WT), in meters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal dyspnoea (mesured by mMRC scale).</measure>
    <time_frame>8 weeks</time_frame>
    <description>To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by mMRC scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire).</measure>
    <time_frame>8 weeks</time_frame>
    <description>To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by the dyspnoea area of CRQ questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF36 questionnaire).</measure>
    <time_frame>8 weeks</time_frame>
    <description>To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (KBILD questionnaire).</measure>
    <time_frame>8 weeks</time_frame>
    <description>To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Intersticial Lung Disease</condition>
  <arm_group>
    <arm_group_label>Conventional oxygen (EPIDOC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized in conventional oxygen (EPIDOC) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to flow needed to maintain SpO2 ≥ 90% during training with both systems.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal High-Flow oxygen therapy (EPIDOAF)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be randomized in nasal High-Flow oxygen therapy (EPIDOAF) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to FiO2 needed to maintain SpO2 ≥ 90% during training with both systems.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxygen therapy</intervention_name>
    <description>conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.</description>
    <arm_group_label>Conventional oxygen (EPIDOC)</arm_group_label>
    <arm_group_label>Nasal High-Flow oxygen therapy (EPIDOAF)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 30 years old&#xD;
&#xD;
          -  Diagnostic of ILD according to the national and international guidelines 23&#xD;
&#xD;
          -  Being clinically stable the previous 4 weeks&#xD;
&#xD;
          -  Acceptance to participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have been enrolled in a PR program in the last previous 6 months&#xD;
&#xD;
          -  Respiratory Diseases other than ILD or severe comorbidities&#xD;
&#xD;
          -  Osteoarticular diseases which don't allow training&#xD;
&#xD;
          -  End-stage ILD, treatment with opiates or survival &lt; 6 months&#xD;
&#xD;
          -  Cognitive alterations that preclude colaboration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</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>Lung Diseases</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/NCT03287713
org study id: IIBSP-OXI-2017-18
nct id: NCT03287713
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objectives: 1.- To compare the level of oxygenation achieved during muscular training with
      conventional oxygen systems (nasal cannulas) versus nasal High-flow oxygen therapy. 2.-To
      compare benefits achieved with both systems, in terms of: level of exercise during training;
      effort tolerance in the 6 minutes walking test (6MWT); improvement of dyspnoea and
      Health-related quality of life (HRQoL). And analyse the effects of nasal High-flow oxygen
      therapy on the acute exercise in a subgroup of patients.

      Method: Multicentric randomized clinical trial. Patients with ILD in fibrotic phase who
      present oxygen desaturation during 6MWT (SpO2 mean ≤ 85%) will be included consecutively.
      Will be randomized in two groups: ILD patients with conventional oxygen (EPIDOC) and ILD
      patients with nasal High-Flow oxygen therapy (EPIDOAF). Both groups will perform a Pulmonary
      Rehabilitation Program. Oxygen will be titrated respectively to flow and FiO2 needed to
      maintain SpO2 ≥ 90% during training with both systems. Evaluation measures: SpO2 during
      training in both groups; dyspnoea (mMRC scale and CRQ dyspnoea); exercise capacity (6MWT) and
      HRQoL (self- administered KBILD questionnaire and SF36). In a subgroup of patients will be
      compared time of endurance exercise to evaluate the effects of nasal high-flow oxygen therapy
      in the acute exercise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation
time frame: 8 weeks
description: To compare the level of oxygenation (in SatO2 %) achieved by conventional oxygen therapy and nasal high flow oxygen therapy during muscular training program in patients with ILD measured by pulseoxymetry.
measure: Dyspnoea (benefits in borg scale) DURING effort.
time frame: 8 weeks
description: To compare the benefits in dyspnoea achieved by both systems in terms of Effort level during the training period measured by Borg Scale.
measure: Effort capacity (Benefits in terms of meters walked in the 6mwt).
time frame: 8 weeks
description: To compare the benefits achieved by both systems in terms of Effort tolerance after PR program, evaluated with the 6 minut waking test (6WT), in meters.
measure: Basal dyspnoea (mesured by mMRC scale).
time frame: 8 weeks
description: To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by mMRC scale.
measure: Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire).
time frame: 8 weeks
description: To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by the dyspnoea area of CRQ questionnaire.
measure: Quality of life (SF36 questionnaire).
time frame: 8 weeks
description: To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire).
measure: Quality of life (KBILD questionnaire).
time frame: 8 weeks
description: To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire).
arm group label: Conventional oxygen (EPIDOC)
arm group type: Active Comparator
description: Patients randomized in conventional oxygen (EPIDOC) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to flow needed to maintain SpO2 ≥ 90% during training with both systems.
arm group label: Nasal High-Flow oxygen therapy (EPIDOAF)
arm group type: Active Comparator
description: Patients will be randomized in nasal High-Flow oxygen therapy (EPIDOAF) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to FiO2 needed to maintain SpO2 ≥ 90% during training with both systems.
intervention type: Drug
intervention name: oxygen therapy
description: conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.
arm group label: Conventional oxygen (EPIDOC)
arm group label: Nasal High-Flow oxygen therapy (EPIDOAF)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Lung Diseases