<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/NCT01734265</url>
  </required_header>
  <id_info>
    <org_study_id>6078-PG-PSC-193</org_study_id>
    <secondary_id>2012-001699-12</secondary_id>
    <nct_id>NCT01734265</nct_id>
  </id_info>
  <brief_title>Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml).</brief_title>
  <official_title>Prospective, Open Uncontrolled Study to Evaluate the Safety of Depigoid With Two Pollen Combinations (Grasses/Olea and Grasses/Parietaria)2000DPP/ml in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Seasonal Asthma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratorios Leti, S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratorios Leti, S.L.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the safety and tolerance of a rush build&#xD;
      up administration of Depigoid forte pollen and the first maintenance dose administered 4&#xD;
      weeks later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to evaluate the safety and tolerance of a rush build&#xD;
      up administration of Depigoid forte pollen and the first maintenance dose administered 4&#xD;
      weeks later. The treatment period consists, thus, of 4 weeks.&#xD;
&#xD;
      Primary variable:&#xD;
&#xD;
      •Number of subjects [%] suffering at least one immediate or delayed systemic reaction of&#xD;
      grade 2 or higher during the 4-weeks treatment period [grading according to the 2006 EAACI&#xD;
      standards&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>immediate or delayed systemic reaction of grade 2 or higher during the treatment period</measure>
    <time_frame>4 weeks</time_frame>
    <description>The primary variable in this study is the number of subjects [%] who experienced at least one immediate or delayed systemic reaction of grade 2 or higher during the treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>immediate and/or delayed systemic reactions and immediate and/or delayed local reactions</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of subjects [%] suffering immediate and/or delayed systemic reactions broken down by grade (EAACI classification).&#xD;
Number of subjects [%] suffering immediate and/or delayed local reactions broken down by diameter (&lt; 5 cm, 5-10 cm or &gt; 10 cm).&#xD;
Number of immediate and/or delayed systemic reactions broken down by grade (EAACI classification).&#xD;
Number of immediate and/or delayed local reactions broken down by diameter (&lt; 5 cm, 5-10 cm and &gt; 10 cm).&#xD;
(Immunology assessment):Measurement of the following immunological parameters: sIgE and sIgG4 at baseline and at the end of the study (after two maintenance doses).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Allergy</condition>
  <condition>Rhinitis</condition>
  <condition>Rhinoconjunctivitis</condition>
  <condition>Seasonal Asthma</condition>
  <arm_group>
    <arm_group_label>Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Depigoid 50%Grasses/ 50% Olea europaea (2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Depigoid 50%Grasses/ 50% Parietaria judaica(2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)</intervention_name>
    <arm_group_label>Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)</intervention_name>
    <arm_group_label>Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has dated and signed the informed consent.&#xD;
&#xD;
          -  Men and women between 18 and 60 years of age (both inclusive).&#xD;
&#xD;
          -  Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at&#xD;
             least the preceding year, with or without allergic seasonal asthma caused by a&#xD;
             clinically relevant sensitization to pollens (grasses AND P. judaica or O. europaea).&#xD;
             Asthmatic patients can be included in the trial only if seasonal asthma is controlled&#xD;
             with a medium daily dose minor or equal to 800 μg/day of budesonide or an equivalent&#xD;
             or minor or equal to 400 μg/day of budesonide or an equivalent plus a long-acting- β2&#xD;
             agonist.&#xD;
&#xD;
          -  Asthmatic patients must be stable within 3 months prior to Visit 1 and on an stable&#xD;
             inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study. FEV1&#xD;
             must be ≥ 80% of predicted value.&#xD;
&#xD;
          -  The IgE-mediated sensitization must be demonstrated by the following:&#xD;
&#xD;
        medical history AND IgE specific CAP RAST ≥ 2 to the suspected relevant pollens (grass&#xD;
        pollen AND Olea and/or Parietaria) AND a positive skin prick test to grass and Olea and/or&#xD;
        Parietaria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication for treatment with allergen specific immunotherapy.&#xD;
&#xD;
          -  Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value &lt;80% of the&#xD;
             predicted normal value.&#xD;
&#xD;
          -  Clinically relevant allergy symptoms due to sensitization to perennial allergens&#xD;
             (mites, molds, epithelia) or other seasonal pollen which might interfere with the&#xD;
             safety of the IMP.&#xD;
&#xD;
          -  Asthma requiring a dose &gt; 800 μg/day of Budesonide or an equivalent, without&#xD;
             long-lasting beta-2 agonists or requiring a dose &gt; of 400 μg/day of Budesonide or an&#xD;
             equivalent plus a long-acting-β2 agonist to reach asthma control, according to the&#xD;
             Global Initiative for Asthma (GINA 2010)&#xD;
&#xD;
          -  Patients with non controlled bronchial asthma within 3 months prior to Visit 1.&#xD;
&#xD;
          -  Patients with asthma who have been treated with systemic steroids within 3 months&#xD;
             prior to V1.&#xD;
&#xD;
          -  Patients with hospital admission due to asthma exacerbations within 1 year prior to&#xD;
             V1.&#xD;
&#xD;
          -  Acute or chronic inflammatory or infectious diseases of the airways.&#xD;
&#xD;
          -  Chronic structural diseases of the respiratory system (for example, emphysema or&#xD;
             bronchiectasis).&#xD;
&#xD;
          -  Immune system diseases, both autoimmune diseases and immunodeficiency.&#xD;
&#xD;
          -  Any disease involving a contraindication for the use of adrenaline (for example,&#xD;
             hyperthyroidism).&#xD;
&#xD;
          -  Serious uncontrolled diseases involving a risk for the subjects participating in this&#xD;
             study&#xD;
&#xD;
          -  Malignant disease with activity in the last 5 years.&#xD;
&#xD;
          -  Excessive consumption of alcohol, drugs or medication.&#xD;
&#xD;
          -  Serious psychiatric, psychological or neurological disorders.&#xD;
&#xD;
          -  Systemic or topical treatment with beta-blocker drugs 1 week before visit 2.&#xD;
&#xD;
          -  Treatment with substances interfering with the immune system 2 weeks before visit 2.&#xD;
&#xD;
          -  Use of tricyclic, tetracyclic and IMAO antidepressants. It will not be allowed to wash&#xD;
             up antidepressants to enter the study because of the risks of interrupting&#xD;
             antidepressant treatment, so patients on antidepressants therapy cannot be included in&#xD;
             the trial.&#xD;
&#xD;
          -  Use of systemic corticosteroids 3 months before visit 1.&#xD;
&#xD;
          -  Immunization with prophylactic (bacterial or viral) vaccines within 7 days before&#xD;
             visit 1 (prophylactic vaccines are allowed during the administration of IMP period&#xD;
             provided they are administered at least one week after IMP administration and the next&#xD;
             IMP administration is administered at least 14 days later).&#xD;
&#xD;
          -  Participation of the subject in another clinical trial 30 days before visit 2&#xD;
&#xD;
          -  Subjects who are going to donate stem cells, blood, organs or bone marrow in the&#xD;
             course of the study.&#xD;
&#xD;
          -  Female subjects who are pregnant or nursing and women with a positive pregnancy test&#xD;
             at visit 1 or 2.&#xD;
&#xD;
          -  Women of childbearing potential not using highly effective methods of birth control.&#xD;
&#xD;
          -  Subjects who are unable to comply with the requirements of the study or who in the&#xD;
             opinion of the investigator should not participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pedro Guardia, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Virgen Macarena</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joaquín Quiralte, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Virgen del Rocío</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luis Angel Navarro, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Luis Alcañiz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Santiago Nevot, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Manresa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Manresa</name>
      <address>
        <city>Manresa</city>
        <state>Barcelona</state>
        <zip>08243</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Luis Alcañiz</name>
      <address>
        <city>Xativa</city>
        <state>Valencia</state>
        <zip>46800</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>January 28, 2014</last_update_submitted>
  <last_update_submitted_qc>January 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <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/NCT01734265
org study id: 6078-PG-PSC-193
secondary id: 2012-001699-12
nct id: NCT01734265
lead sponsor: 
has dmc: No
The primary objective of this study is to evaluate the safety and tolerance of a rush build
      up administration of Depigoid forte pollen and the first maintenance dose administered 4
      weeks later.
The primary objective of this study is to evaluate the safety and tolerance of a rush build
      up administration of Depigoid forte pollen and the first maintenance dose administered 4
      weeks later. The treatment period consists, thus, of 4 weeks.

      Primary variable:

      •Number of subjects [%] suffering at least one immediate or delayed systemic reaction of
      grade 2 or higher during the 4-weeks treatment period [grading according to the 2006 EAACI
      standards
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: immediate or delayed systemic reaction of grade 2 or higher during the treatment period
time frame: 4 weeks
description: The primary variable in this study is the number of subjects [%] who experienced at least one immediate or delayed systemic reaction of grade 2 or higher during the treatment period.
measure: immediate and/or delayed systemic reactions and immediate and/or delayed local reactions
time frame: 4 weeks
description: Number of subjects [%] suffering immediate and/or delayed systemic reactions broken down by grade (EAACI classification).
Number of subjects [%] suffering immediate and/or delayed local reactions broken down by diameter (< 5 cm, 5-10 cm or > 10 cm).
Number of immediate and/or delayed systemic reactions broken down by grade (EAACI classification).
Number of immediate and/or delayed local reactions broken down by diameter (< 5 cm, 5-10 cm and > 10 cm).
(Immunology assessment):Measurement of the following immunological parameters: sIgE and sIgG4 at baseline and at the end of the study (after two maintenance doses).
arm group label: Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)
arm group type: Experimental
description: Depigoid 50%Grasses/ 50% Olea europaea (2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later.
arm group label: Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)
arm group type: Experimental
description: Depigoid 50%Grasses/ 50% Parietaria judaica(2.000 DPP/ml) The administration regimen will consist of a rush build-up regimen: 0.2 ml followed by 0.3 ml after 30 minutes if no adverse events occur a second maintenance dose of 0,5 ml 4 weeks later.
intervention type: Drug
intervention name: Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)
arm group label: Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)
intervention type: Drug
intervention name: Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)
arm group label: Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Pedro Guardia, Dr
role: Principal Investigator
affiliation: H. Virgen Macarena
last name: Joaquín Quiralte, Dr
role: Principal Investigator
affiliation: H. Virgen del Rocío
last name: Luis Angel Navarro, Dr
role: Principal Investigator
affiliation: H. Luis Alcañiz
last name: Santiago Nevot, Dr
role: Principal Investigator
affiliation: H. Manresa
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Asthma