<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/NCT03293407</url>
  </required_header>
  <id_info>
    <org_study_id>19398</org_study_id>
    <nct_id>NCT03293407</nct_id>
  </id_info>
  <brief_title>Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension</brief_title>
  <acronym>VENTASTEP</acronym>
  <official_title>Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
      The main aim of the observational VENTASTEP study was to investigate the association between&#xD;
      changes in clinical outcome measures and changes in device outcome measures in PAH patients&#xD;
      using the new Breelib nebulizer in a real life setting.&#xD;
&#xD;
      The study was not designed to investigate or confirm the effectiveness and safety of&#xD;
      iloprost.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">January 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Six-minute walking distance (6MWD)</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Clinical outcome measured by study nurse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of laboratory results of the biomarkers NT-pro BNP/BNP</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of World Health Organization functional class</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Distance Walked per day</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Number of Steps per day</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of number of floors climbed (10 feet) per day</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of time spent at home per day</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of number of relevant location changes per day</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of number of times leaving home per day</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of number of times standing up per day</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of 6MWD</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Device based outcome measured by smart device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rates during baseline and observation period</measure>
    <time_frame>Up to 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The average daily inhalation duration per session</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The average number of daily inhalations</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of sleep quality</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Measured by Pittsburgh Sleep Quality Index (PSQI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs</measure>
    <time_frame>Up to 3 months after first inhalation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of heart rate during 6MWD</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The average daily proportion of complete/incomplete inhalations</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The average association between physical activity level (wearable device based) and time to last inhalation</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">31</enrollment>
  <condition>Hypertension, Pulmonary</condition>
  <arm_group>
    <arm_group_label>BAYQ6256_Ventavis</arm_group_label>
    <description>Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iloprost (Ventavis, BAYQ6256)</intervention_name>
    <description>Using Breelib device</description>
    <arm_group_label>BAYQ6256_Ventavis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Breelib nebulizer</intervention_name>
    <description>Used for inhalation of Ventavis</description>
    <arm_group_label>BAYQ6256_Ventavis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with pulmonary hypertension at intermediate risk and WHO FC III who failed to&#xD;
        respond adequately to initial therapy with one or more PAH drugs or who clinically&#xD;
        deteriorated after initial treatment response and for whom a therapy escalation with&#xD;
        Ventavis (Iloprost) has been agreed by patient and physician.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ventavis-treatment naïve patients aged ≥18 years at initiation of Ventavis (Iloprost)&#xD;
             therapy diagnosed with pulmonary arterial hypertension WHO FC III&#xD;
&#xD;
          -  Patients who are planned to be treated with Ventavis (Iloprost) and where the decision&#xD;
             to use the Breelib has been agreed by physician and patient&#xD;
&#xD;
          -  Patients who are willing to wear a smart watch (iWatch2) over the observation period&#xD;
             of 3 months ± 2 weeks&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients allergic to Nickel and Methacrylates&#xD;
&#xD;
          -  Patients participating in an investigational program with interventions outside of&#xD;
             routine clinical practice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <reference>
    <citation>Mueller C, Stollfuss B, Roitenberg A, Harder J, Richter MJ. Evaluation of Clinical Outcomes and Simultaneous Digital Tracking of Daily Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Protocol for the Observational VENTASTEP Study. JMIR Res Protoc. 2019 Apr 15;8(4):e12144. doi: 10.2196/12144.</citation>
    <PMID>30985279</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>May 25, 2021</last_update_submitted>
  <last_update_submitted_qc>May 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary arterial hypertension</keyword>
  <keyword>PAH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iloprost</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/NCT03293407
org study id: 19398
nct id: NCT03293407
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of the observational VENTASTEP study was to investigate the association between
      changes in clinical outcome measures and changes in device outcome measures in PAH patients
      using the new Breelib nebulizer in a real life setting.

      The study was not designed to investigate or confirm the effectiveness and safety of
      iloprost.
observational model: Cohort
time perspective: Prospective
measure: Change of Six-minute walking distance (6MWD)
time frame: Baseline and 3 months
description: Clinical outcome measured by study nurse.
measure: Change of laboratory results of the biomarkers NT-pro BNP/BNP
time frame: Baseline and 3 months
measure: Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D)
time frame: Baseline and 3 months
measure: Change of World Health Organization functional class
time frame: Baseline and 3 months
measure: Change of Distance Walked per day
time frame: Baseline and 3 months
measure: Change of Number of Steps per day
time frame: Baseline and 3 months
measure: Change of number of floors climbed (10 feet) per day
time frame: Baseline and 3 months
measure: Change of time spent at home per day
time frame: Baseline and 3 months
measure: Change of number of relevant location changes per day
time frame: Baseline and 3 months
measure: Change of number of times leaving home per day
time frame: Baseline and 3 months
measure: Change of number of times standing up per day
time frame: Baseline and 3 months
measure: Change of 6MWD
time frame: Baseline and 3 months
description: Device based outcome measured by smart device.
measure: Heart rates during baseline and observation period
time frame: Up to 3 months
measure: The average daily inhalation duration per session
time frame: Up to 3 months
measure: The average number of daily inhalations
time frame: Up to 3 months
measure: Change of sleep quality
time frame: Baseline and 3 months
description: Measured by Pittsburgh Sleep Quality Index (PSQI).
measure: Incidence of AEs
time frame: Up to 3 months after first inhalation
measure: Change of heart rate during 6MWD
time frame: Baseline and 3 months
measure: The average daily proportion of complete/incomplete inhalations
time frame: Up to 3 months
measure: The average association between physical activity level (wearable device based) and time to last inhalation
time frame: Up to 3 months
arm group label: BAYQ6256_Ventavis
description: Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician
intervention type: Drug
intervention name: Iloprost (Ventavis, BAYQ6256)
description: Using Breelib device
arm group label: BAYQ6256_Ventavis
intervention type: Device
intervention name: Breelib nebulizer
description: Used for inhalation of Ventavis
arm group label: BAYQ6256_Ventavis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
url: https://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
citation: Mueller C, Stollfuss B, Roitenberg A, Harder J, Richter MJ. Evaluation of Clinical Outcomes and Simultaneous Digital Tracking of Daily Physical Activity, Heart Rate, and Inhalation Behavior in Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost: Protocol for the Observational VENTASTEP Study. JMIR Res Protoc. 2019 Apr 15;8(4):e12144. doi: 10.2196/12144.
PMID: 30985279
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Iloprost