<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/NCT01674595</url>
  </required_header>
  <id_info>
    <org_study_id>AV-X-01</org_study_id>
    <secondary_id>2011-004852-20</secondary_id>
    <nct_id>NCT01674595</nct_id>
  </id_info>
  <brief_title>An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy</brief_title>
  <official_title>An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ALK-Abelló A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ALK-Abelló A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is an open, national, multi-centre trial. The trial will be initiated after olive&#xD;
      pollen season 2012 and subjects will receive treatment for 6 weeks.&#xD;
&#xD;
      The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The&#xD;
      frequency of patients with adverse reactions will be the primary endpoint.&#xD;
&#xD;
      Frequency of patients with systemic reactions according to EAACI classification, increase in&#xD;
      IgG4 and in IgE and reduction in immediate skin reactivity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of patients with adverse reactions.</measure>
    <time_frame>Participants will be followed for an expected average of 6 week.s</time_frame>
    <description>From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of patients with systemic reactions according to EAACI classification.</measure>
    <time_frame>Participants will be followed for an expected average of 6 weeks.</time_frame>
    <description>From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Allergic Rhinitis Due to Olea Europaea Pollen</condition>
  <arm_group>
    <arm_group_label>Immunotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AVANZ</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AVANZ olea</intervention_name>
    <description>Immunotherapy Olea europaea</description>
    <arm_group_label>Immunotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients 18-65 years of age.&#xD;
&#xD;
          2. A clinical history of olive pollen induced allergic rhinoconjunctivitis with or&#xD;
             without asthma at least one year prior to trial entry.&#xD;
&#xD;
          3. Positive SPT to olive pollen (wheal diameter ≥ 3 mm).&#xD;
&#xD;
          4. A positive specific IgE against olive pollen (≥Class 2; ≥0.70 KU/L) documented in the&#xD;
             last 5 y&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. FEV1 &lt; 70% of predicted value at screening after adequate pharmacologic treatment.&#xD;
&#xD;
          2. Uncontrolled or severe asthma.&#xD;
&#xD;
          3. A clinically relevant history of symptomatic perennial allergic rhinitis and/or&#xD;
             conjunctivitis caused by an allergen to which the subject is regularly exposed and&#xD;
             sensitized.&#xD;
&#xD;
          4. History of severe asthma exacerbation or emergency room visit or admission for asthma&#xD;
             in the previous 12 months.&#xD;
&#xD;
          5. At screening, current symptoms of, or treatment for, upper respiratory tract&#xD;
             infection, acute sinusitis, acute otitis media or other relevant infection (serous&#xD;
             otitis media is not an exclusion criterion).&#xD;
&#xD;
          6. Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the&#xD;
             previous 3 months or during the study (except for steroids if needed as rescue&#xD;
             medication).&#xD;
&#xD;
          7. Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic&#xD;
             antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug&#xD;
             containing alum (e.g. antacids) taken on a daily basis.&#xD;
&#xD;
          8. Previous treatment by other allergen concomitant IT or immunotherapy with Olea&#xD;
             europaea extracts within the previous 5 years (initiation of subcutaneous&#xD;
             immunotherapy is acceptable if treatment has been discontinued before reaching&#xD;
             maintenance dose; for SLIT 3 months in the last 5 years is accepted).&#xD;
&#xD;
          9. History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.&#xD;
&#xD;
         10. History of severe and recurrent angioedema.&#xD;
&#xD;
         11. Any contraindication according to the Investigator Brochure (IB).&#xD;
&#xD;
         12. Use of an investigational drug within 30 days prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CARMEN MORENO, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HOSPITAL UNIVERSITARIO REINA SOFÍA Córdoba- Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofía</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>April 29, 2013</last_update_submitted>
  <last_update_submitted_qc>April 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Olea sensitization</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>
  </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/NCT01674595
org study id: AV-X-01
secondary id: 2011-004852-20
nct id: NCT01674595
lead sponsor: 
has dmc: No
This trial is an open, national, multi-centre trial. The trial will be initiated after olive
      pollen season 2012 and subjects will receive treatment for 6 weeks.

      The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The
      frequency of patients with adverse reactions will be the primary endpoint.

      Frequency of patients with systemic reactions according to EAACI classification, increase in
      IgG4 and in IgE and reduction in immediate skin reactivity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of patients with adverse reactions.
time frame: Participants will be followed for an expected average of 6 week.s
description: From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.
measure: Frequency of patients with systemic reactions according to EAACI classification.
time frame: Participants will be followed for an expected average of 6 weeks.
description: From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.
arm group label: Immunotherapy
arm group type: Experimental
description: AVANZ
intervention type: Biological
intervention name: AVANZ olea
description: Immunotherapy Olea europaea
arm group label: Immunotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: CARMEN MORENO, MD
role: Principal Investigator
affiliation: HOSPITAL UNIVERSITARIO REINA SOFÍA Córdoba- Spain
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic