<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/NCT03304548</url>
  </required_header>
  <id_info>
    <org_study_id>207754</org_study_id>
    <nct_id>NCT03304548</nct_id>
  </id_info>
  <brief_title>Qualitative Research to Explore Treatment Preference in Pulmonary Arterial Hypertension (PAH) Subjects</brief_title>
  <official_title>Qualitative Research to Explore Patient Preference for Modes of Administration in Pulmonary Arterial Hypertension Treatments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Adelphi Values</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</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>
      GlaxoSmithKline (GSK) is embarking on a clinical program to assess the treatment of PAH with&#xD;
      an Angiotensin converting enzyme 2 (ACE2). This new treatment may require subcutaneous&#xD;
      administration, in comparison to current treatments which are taken orally. Hence, GSK would&#xD;
      like to conduct this qualitative interview study with PAH subjects to explore subject's&#xD;
      perspective and preferences for various modes of treatment administration (daily or weekly&#xD;
      subcutaneous injection versus current treatment options). This will be a qualitative study&#xD;
      comprising the conduct of semi-structured telephone concept elicitation interviews with 8 to&#xD;
      10 PAH subjects (each approximately 30 minutes in duration) in the United States (US).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2017</start_date>
  <completion_date type="Actual">April 10, 2018</completion_date>
  <primary_completion_date type="Actual">April 10, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects who preferred subcutaneous injection versus current treatment options</measure>
    <time_frame>Up to 30 minutes</time_frame>
    <description>All recruited subjects will take part in a 30-minute telephone interview. Subjects will be given brief descriptions of hypothetical injection and inhaled treatments and will be asked for their thoughts towards these treatments individually.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Hypertension, Pulmonary</condition>
  <arm_group>
    <arm_group_label>All subjects with PAH</arm_group_label>
    <description>A total of 8 to 10 US-English speaking PAH subjects will be recruited. They will take part in a 30-minute telephone concept elicitation interview. All interviews will be audio-recorded and transcribed verbatim.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telephone concept elicitation interview</intervention_name>
    <description>All interview questions are designed to be very open-ended in order to ascertain subjects' preferences in an un-biased manner (as possible), with additional probes only being used when necessary to ensure all concepts of interest are covered. Subjects will be asked a series of broad, open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of taking oral treatment(s) for their PAH.</description>
    <arm_group_label>All subjects with PAH</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A sample of 8 to 10 US-English speaking subjects will be recruited. Recruitment will be&#xD;
        facilitated by a third-party vendor in the US. A purposive approach to sampling will be&#xD;
        employed to ensure subjects with a range of demographic and clinical characteristics are&#xD;
        recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, at least 18 years of age.&#xD;
&#xD;
          -  Subject is willing and able to provide written informed consent.&#xD;
&#xD;
          -  Subject must have a diagnosis of symptomatic Pulmonary Arterial Hypertension Type I as&#xD;
             per the World Health Organization (WHO) clinical classification system.&#xD;
&#xD;
          -  Subject must have the cognitive and linguistic capabilities sufficient to allow them&#xD;
             to actively participate in an interview lasting 30 minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a diagnosis of other cardiac or pulmonary disease.&#xD;
&#xD;
          -  Subject has a Type II-V diagnosis of PAH, as per the WHO clinical classification&#xD;
             system.&#xD;
&#xD;
          -  Subject is currently receiving treatment for PAH via modes of administration other&#xD;
             than intravenously or orally.&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 29, 2019</last_update_submitted>
  <last_update_submitted_qc>March 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telephone interviews</keyword>
  <keyword>Subcutaneous</keyword>
  <keyword>Low-interventional</keyword>
  <keyword>Qualitative research</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>
  <!-- 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/NCT03304548
org study id: 207754
nct id: NCT03304548
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
GlaxoSmithKline (GSK) is embarking on a clinical program to assess the treatment of PAH with
      an Angiotensin converting enzyme 2 (ACE2). This new treatment may require subcutaneous
      administration, in comparison to current treatments which are taken orally. Hence, GSK would
      like to conduct this qualitative interview study with PAH subjects to explore subject's
      perspective and preferences for various modes of treatment administration (daily or weekly
      subcutaneous injection versus current treatment options). This will be a qualitative study
      comprising the conduct of semi-structured telephone concept elicitation interviews with 8 to
      10 PAH subjects (each approximately 30 minutes in duration) in the United States (US).
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of subjects who preferred subcutaneous injection versus current treatment options
time frame: Up to 30 minutes
description: All recruited subjects will take part in a 30-minute telephone interview. Subjects will be given brief descriptions of hypothetical injection and inhaled treatments and will be asked for their thoughts towards these treatments individually.
arm group label: All subjects with PAH
description: A total of 8 to 10 US-English speaking PAH subjects will be recruited. They will take part in a 30-minute telephone concept elicitation interview. All interviews will be audio-recorded and transcribed verbatim.
intervention type: Other
intervention name: Telephone concept elicitation interview
description: All interview questions are designed to be very open-ended in order to ascertain subjects' preferences in an un-biased manner (as possible), with additional probes only being used when necessary to ensure all concepts of interest are covered. Subjects will be asked a series of broad, open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of taking oral treatment(s) for their PAH.
arm group label: All subjects with PAH
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension, Pulmonary
mesh term: Hypertension