<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/NCT01692041</url>
  </required_header>
  <id_info>
    <org_study_id>HeHe</org_study_id>
    <nct_id>NCT01692041</nct_id>
  </id_info>
  <brief_title>Effect of an add-on Treatment With Ivy Leaves Dry Extract on Lung Function in Bronchial Asthma</brief_title>
  <acronym>HeHe</acronym>
  <official_title>Tolerance and Effect of an add-on Treatment With a Cough Medicine Containing Ivy Leaves Dry Extract on Lung Function in Children With Bronchial Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial aims to record possible effects of a supplementary treatment with ivy leaves dry&#xD;
      extract on different lung function parameter, on bronchial hyperreactivity, on individual&#xD;
      markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is,&#xD;
      that the additional therapy might improve these parameters and might help to optimize asthma&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MEF75-25 before bronchodilation - relative change</measure>
    <time_frame>every 4 weeks</time_frame>
    <description>MEF75-25 will be measured at every time point of the study and relative changes will be followed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1 before bronchodilation - relative change</measure>
    <time_frame>every 4 weeks</time_frame>
    <description>FEV1 before bronchodilation will be measured at every study visit and changes will be documented</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MEF75-25 before bronchodilation - absolute change</measure>
    <time_frame>every 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1 before bronchodilation - absolute change</measure>
    <time_frame>every 4 weeks</time_frame>
    <description>FEV1 before bronchodilation will be measured every visit and changes documented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency treatment (beta agonist demand)</measure>
    <time_frame>daily</time_frame>
    <description>Emergency treatment (beta agonist demand)will be documented daily at home and checked at every study visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days with asthma symptoms</measure>
    <time_frame>daily</time_frame>
    <description>Number of days with asthma symptoms will be documented daily and checked at every study visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Ivy leave</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ivy leave placebo 5 ml twice daily p.o. for four weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ivy leaves dry extract</intervention_name>
    <description>5 ml twice daily po</description>
    <arm_group_label>Ivy leave</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>5 ml per os twice daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medical diagnosis of uncontrolled, mild, persistent, allergic bronchial asthma in&#xD;
             terms of the bronchial asthma NVL Version 1.3 (2011)&#xD;
&#xD;
          2. Children aged from 6 to 12 years (girls and boys)&#xD;
&#xD;
          3. Signed Informed Consent of the patient and his legal guardians to participate in the&#xD;
             trial after written and verbal briefing by the Investigator&#xD;
&#xD;
          4. Improvement of the FEV1≥12% after 2 puffs of terbutaline 100 µg dur-ing steroid&#xD;
             monotherapy with 400 µg budesonide equivalent/day or an ACT score ≤ 19 as an&#xD;
             indication of insufficient asthma control&#xD;
&#xD;
          5. Asthma diagnosis for at least 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anamnestically known intolerance/allergy to one of the drugs applied or to their&#xD;
             ingredients or to drugs of similar chemical structure&#xD;
&#xD;
          2. Participation of the patient in another clinical trial within the last four weeks&#xD;
             before enrollment in this trial&#xD;
&#xD;
          3. Evidence suggesting that the patient or their legal representative is not likely to&#xD;
             follow the trial protocol (e.g. lacking compliance)&#xD;
&#xD;
          4. Inability to measure lung function, to test bronchospasmolysis, to determine FeNO or&#xD;
             to collect exhaled breath condensate, inability to document the symptoms in a symptom&#xD;
             log book or questionnaire; in-ability to take the trial medication properly&#xD;
&#xD;
          5. Chronic illnesses of different aetiology&#xD;
&#xD;
          6. Vocal cord dysfunction&#xD;
&#xD;
          7. Premature birth or diagnosis of bronchopulmonary dysplasia&#xD;
&#xD;
          8. Gastroesophageal reflux&#xD;
&#xD;
          9. Acute respiratory infection within the previous 4 weeks&#xD;
&#xD;
         10. Hereditary fructose intolerance&#xD;
&#xD;
         11. Pregnant or breastfeeding girls -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christian Vogelberg, MD PhD</last_name>
    <phone>0049 351 458 2073</phone>
    <email>christian.vogelberg@uniklinikum-dresden.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus, Kinderklinik</name>
      <address>
        <city>Dresden</city>
        <state>Saxonia</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Vogelberg, MD PhD</last_name>
      <phone>0049 351 458</phone>
      <phone_ext>2073</phone_ext>
      <email>christian.vogelberg@uniklinikum-dresden.de</email>
    </contact>
    <investigator>
      <last_name>Christian Vogelberg, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sabine Zeil, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>May 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT01692041
org study id: HeHe
nct id: NCT01692041
lead sponsor: 
has dmc: Yes
The trial aims to record possible effects of a supplementary treatment with ivy leaves dry
      extract on different lung function parameter, on bronchial hyperreactivity, on individual
      markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is,
      that the additional therapy might improve these parameters and might help to optimize asthma
      therapy.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: MEF75-25 before bronchodilation - relative change
time frame: every 4 weeks
description: MEF75-25 will be measured at every time point of the study and relative changes will be followed
measure: FEV1 before bronchodilation - relative change
time frame: every 4 weeks
description: FEV1 before bronchodilation will be measured at every study visit and changes will be documented
measure: MEF75-25 before bronchodilation - absolute change
time frame: every 4 weeks
measure: FEV1 before bronchodilation - absolute change
time frame: every 4 weeks
description: FEV1 before bronchodilation will be measured every visit and changes documented
measure: Emergency treatment (beta agonist demand)
time frame: daily
description: Emergency treatment (beta agonist demand)will be documented daily at home and checked at every study visit
measure: Number of days with asthma symptoms
time frame: daily
description: Number of days with asthma symptoms will be documented daily and checked at every study visit.
arm group label: Ivy leave
arm group type: Active Comparator
description: active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Ivy leave placebo 5 ml twice daily p.o. for four weeks
intervention type: Drug
intervention name: ivy leaves dry extract
description: 5 ml twice daily po
arm group label: Ivy leave
intervention type: Drug
intervention name: Placebo
description: 5 ml per os twice daily
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Christian Vogelberg, MD PhD
phone: 0049 351 458 2073
email: christian.vogelberg@uniklinikum-dresden.de
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Asthma