<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/NCT01660737</url>
  </required_header>
  <id_info>
    <org_study_id>180A12PALL</org_study_id>
    <nct_id>NCT01660737</nct_id>
  </id_info>
  <brief_title>Observational Study With PASCALLERG ® in Patients With Hay Fever</brief_title>
  <official_title>Observational Study With PASCALLERG ® in Patients With Hay Fever</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pascoe Pharmazeutische Praeparate GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pascoe Pharmazeutische Praeparate GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this observational study is to document the therapeutic use of PASCALLERG ® for&#xD;
      hay fever. Based on the survey is a decrease in disease-specific symptoms when taking&#xD;
      PASCALLERG ® over a period of 4 weeks will be documented. In addition to the compatibility&#xD;
      can be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are documented male and female patients over the age of one year who suffer from hay&#xD;
      fever. The traetment time is about a period of 4 weeks with PASCALLERG® tablets.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Efficacy of Pascallerg</measure>
    <time_frame>appr. 4 weeks after baseline (after appr. 4 weeks of treatment)</time_frame>
    <description>Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerability of Pascallerg</measure>
    <time_frame>app. 4 weeks after baseline (treatment app. for 4 weeks)</time_frame>
    <description>Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale Well Beeing (Pre- Post)</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Symptom Dry Eyes (Pre- Post)</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Symptom Itching Eyes (Pre- Post)</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Symptom Burning Eyes (Pre-post)</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Symptom Bronchial Complaints (Pre-post)</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Symptom Sneezing (Pre-post)</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Symptom Rhinitis (Pre-post)</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Symtom Fatigue / Tiredness</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Symptom Headache (Pre-post)</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Symptom Tearing Eyes (Pre-post)</measure>
    <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
    <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">123</enrollment>
  <condition>Hay Fever</condition>
  <arm_group>
    <arm_group_label>PASCALLERG® tablets in patients with hay fever</arm_group_label>
    <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients from natural practioners and doctors from Germany&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hay fever&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lactose intolerance and / or&#xD;
&#xD;
          -  Chromium hypersensitivity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jennifer Lebert</name>
      <address>
        <city>Gießen</city>
        <zip>35390</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <results_first_submitted>April 21, 2016</results_first_submitted>
  <results_first_submitted_qc>April 4, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2017</results_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hay fever</keyword>
  <keyword>Pascallerg</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
          <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
          <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="123"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.00" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy of Pascallerg</title>
        <description>Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)</description>
        <time_frame>appr. 4 weeks after baseline (after appr. 4 weeks of treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of Pascallerg</title>
          <description>Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very good efficacy (symptoms complete decline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good efficacy (symptoms clearly improved)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate efficacy (smptoms slightly improved)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No efficacy (symptoms unchanged o worsend)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No data available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tolerability of Pascallerg</title>
        <description>Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)</description>
        <time_frame>app. 4 weeks after baseline (treatment app. for 4 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Tolerability of Pascallerg</title>
          <description>Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bad tolerability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numerical Rating Scale Well Beeing (Pre- Post)</title>
        <description>Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Numerical Rating Scale Well Beeing (Pre- Post)</title>
          <description>Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>detoriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Symptom Dry Eyes (Pre- Post)</title>
        <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Symptom Dry Eyes (Pre- Post)</title>
          <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deteriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Symptom Itching Eyes (Pre- Post)</title>
        <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Symptom Itching Eyes (Pre- Post)</title>
          <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deteriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Symptom Burning Eyes (Pre-post)</title>
        <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Symptom Burning Eyes (Pre-post)</title>
          <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deteriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Symptom Bronchial Complaints (Pre-post)</title>
        <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Symptom Bronchial Complaints (Pre-post)</title>
          <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deterioreated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Symptom Sneezing (Pre-post)</title>
        <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Symptom Sneezing (Pre-post)</title>
          <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deteriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Symptom Rhinitis (Pre-post)</title>
        <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Symptom Rhinitis (Pre-post)</title>
          <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deteriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Symtom Fatigue / Tiredness</title>
        <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Symtom Fatigue / Tiredness</title>
          <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deteriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Symptom Headache (Pre-post)</title>
        <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Symptom Headache (Pre-post)</title>
          <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deteriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Symptom Tearing Eyes (Pre-post)</title>
        <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
        <time_frame>Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
            <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Symptom Tearing Eyes (Pre-post)</title>
          <description>Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unchanged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>deteriorated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PASCALLERG® Tablets in Patients With Hay Fever</title>
          <description>Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="123"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jennifer Lebert</name_or_title>
      <organization>PASCOE Pharamzeutische Präparate GmbH</organization>
      <phone>0049+(0)641-7960-955</phone>
      <email>Jennifer.lebert@pascoe.de</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01660737
org study id: 180A12PALL
nct id: NCT01660737
lead sponsor: 
has dmc: No
The aim of this observational study is to document the therapeutic use of PASCALLERG ® for
      hay fever. Based on the survey is a decrease in disease-specific symptoms when taking
      PASCALLERG ® over a period of 4 weeks will be documented. In addition to the compatibility
      can be assessed.
There are documented male and female patients over the age of one year who suffer from hay
      fever. The traetment time is about a period of 4 weeks with PASCALLERG® tablets.
observational model: Cohort
time perspective: Prospective
measure: Efficacy of Pascallerg
time frame: appr. 4 weeks after baseline (after appr. 4 weeks of treatment)
description: Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)
measure: Tolerability of Pascallerg
time frame: app. 4 weeks after baseline (treatment app. for 4 weeks)
description: Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)
measure: Numerical Rating Scale Well Beeing (Pre- Post)
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)
measure: Change of Symptom Dry Eyes (Pre- Post)
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
measure: Change of Symptom Itching Eyes (Pre- Post)
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
measure: Change of Symptom Burning Eyes (Pre-post)
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
measure: Change of Symptom Bronchial Complaints (Pre-post)
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
measure: Change of Symptom Sneezing (Pre-post)
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
measure: Change of Symptom Rhinitis (Pre-post)
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
measure: Change of Symtom Fatigue / Tiredness
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
measure: Change of Symptom Headache (Pre-post)
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
measure: Change of Symptom Tearing Eyes (Pre-post)
time frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)
description: Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)
arm group label: PASCALLERG® tablets in patients with hay fever
description: Patients with lactose intolerance and / or chromium hypersensitivity are excluded from the observational study.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Rhinitis, Allergic, Seasonal
mesh term: Fever
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 