<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/NCT03014661</url>
  </required_header>
  <id_info>
    <org_study_id>PQ-HOM-001</org_study_id>
    <nct_id>NCT03014661</nct_id>
  </id_info>
  <brief_title>Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen</brief_title>
  <official_title>Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universität des Saarlandes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universität des Saarlandes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Questionnaire to measure and control the quality of life of patients with hay fever who are&#xD;
      treated or were treated with Pollinex quattro&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Questionnaire including 19 questions concerning the Quality of life of patients with hayfeyer&#xD;
      under or after therapy with a specific immuntherapy with Pollinex quattro&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life questionnaire (DLQI)</measure>
    <time_frame>during year one, year two, year three of therapy or within 6 months after completion of therapy</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">58</enrollment>
  <condition>Rhinitis, Allergic, Seasonal</condition>
  <arm_group>
    <arm_group_label>Single group study</arm_group_label>
    <description>Single Group study investigating retrospectively the Quality of life of patients with pollinosis under or after specific immunotherapy with Pollinex quattro</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality of life under or after therapy with Pollinex quattro</intervention_name>
    <description>To measure Quality of life using the DLQI-index in year one, year two, year three or six month after therapy with Pollinex quattro plus.</description>
    <arm_group_label>Single group study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult persons with hayfever treated with a specific immunotherapy with Pollinex quattro&#xD;
        plus (Allergens: birch/alder/Hazel or grass/rye or mugwort)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pollinosis/seasonal Rhinitis based on an allergy against birch/alder/Hazel pollen OR&#xD;
             grass/rye pollen OR mugwort&#xD;
&#xD;
          -  Therapy with Polinex quattro&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years.&#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>Saarland University Hospital. Department of Dermatology</name>
      <address>
        <city>Homburg</city>
        <state>Saarland</state>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universität des Saarlandes</investigator_affiliation>
    <investigator_full_name>Claudia Pföhler</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>pollinosis, quality of life, specific immunotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03014661
org study id: PQ-HOM-001
nct id: NCT03014661
lead sponsor: 
has dmc: No
Questionnaire to measure and control the quality of life of patients with hay fever who are
      treated or were treated with Pollinex quattro
Questionnaire including 19 questions concerning the Quality of life of patients with hayfeyer
      under or after therapy with a specific immuntherapy with Pollinex quattro
observational model: Cohort
time perspective: Retrospective
measure: Quality of life questionnaire (DLQI)
time frame: during year one, year two, year three of therapy or within 6 months after completion of therapy
arm group label: Single group study
description: Single Group study investigating retrospectively the Quality of life of patients with pollinosis under or after specific immunotherapy with Pollinex quattro
intervention type: Other
intervention name: Quality of life under or after therapy with Pollinex quattro
description: To measure Quality of life using the DLQI-index in year one, year two, year three or six month after therapy with Pollinex quattro plus.
arm group label: Single group study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Universität des Saarlandes
investigator full name: Claudia Pföhler
investigator title: Prof. Dr.
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal
sharing ipd: No