<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/NCT03821077</url>
  </required_header>
  <id_info>
    <org_study_id>ROX-ALE-2018-01</org_study_id>
    <nct_id>NCT03821077</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of &quot;Allergovac Poliplus&quot; in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Asthma</brief_title>
  <acronym>ARES</acronym>
  <official_title>Prospective Observational Study to Evaluate the Efficacy and Safety of Treatment With &quot;Allergovac Poliplus&quot; in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Associated Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roxall Medicina España S.A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Roxall Medicina España S.A</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational prospective multicenter clinical study, to evaluate the efficacy and&#xD;
      safety of the treatment with Allergovac Poliplus subcutaneous immunotherapy (SCIT) with a&#xD;
      mixture of 2 allergenic extracts (pollens or mites), in polymerized-depot formulation,&#xD;
      administered in its different available allergenic extracts mixtures (2 pollens or 2 mites),&#xD;
      and in one of the 2 recommended administration schedules (1 Day or Rapid).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2018</start_date>
  <completion_date type="Actual">September 13, 2021</completion_date>
  <primary_completion_date type="Actual">September 13, 2021</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>Combined Symptoms and Medication Score (CSMS)</measure>
    <time_frame>Basal-12 months</time_frame>
    <description>The score ranged from 0 to 6 points and is obtained as follows:&#xD;
Symptoms Score (SS) (from 0 to 3 points) + Medication Score (MS) (from 0 to 3 points). Through these 2 sub-scales the total score of the Combined Symptom and Medication Scale (CSMS) is obtained as follows:&#xD;
CSMS = SS (0-3) + MS (0-3) = 0-6 points The 0 value indicate no symptoms and no medication, and 6 points indicate the worst state of symptoms and the highest medication step</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)</measure>
    <time_frame>Basal-12 months</time_frame>
    <description>The RQLQ has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). It is a self-administered questionnaire where patients respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores reflect lower quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number, percentage, severity and gradation of adverse reactions</measure>
    <time_frame>Basal- 6 months-12 months</time_frame>
    <description>Total number, percentage, severity and gradation of adverse reactions reported (local and systemics), in relation to the total number of patients and the total administered doses, both globally and according to each administration schedule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient´s Tolerability assessment using a Likert-type scale</measure>
    <time_frame>6 months-12 months</time_frame>
    <description>Patient´s Tolerability assessment using a Likert-type scale, with a score of 1 to 4 points (from 1 = I have tolerated it very well to 4 = I have tolerated it very badly)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's perception of the improvement in their global status using a Likert-type scale</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation of the patient's perception of the improvement in the global state of the pathology, using a Likert-type scale, with a score of 1 to 4 points (from 1= good or excellent improvement to 4 = worsening)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Satisfaction using a Likert scale</measure>
    <time_frame>12 months</time_frame>
    <description>Degree of patients' satisfaction with the treatment using a Likert scale, with a score of 1 to 4 points (from 1 = Very Satisfied to 4 = Very dissatisfied)</description>
  </secondary_outcome>
  <enrollment type="Actual">122</enrollment>
  <condition>Rhinitis, Allergic</condition>
  <condition>Rhinoconjunctivitis</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Allergen Immunotherapy (AIT)</intervention_name>
    <description>Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation</description>
    <other_name>Allergovac Poliplus</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without&#xD;
        asthma, polisensitized to pollens/mites.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged between 5 and 60 years with allergic rhinitis or rhinoconjunctivitis&#xD;
             mediated by IgE, caused by sensitization to more than one allergenic source (pollens&#xD;
             or mites) and with or without associated mild / moderate asthma.&#xD;
&#xD;
          2. Patients susceptible to receive treatment with Allergovac Poliplus (SCIT), according&#xD;
             to usual clinical practice&#xD;
&#xD;
          3. Patients who have given their signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have received or initiated treatment with Allergovac Poliplus previously&#xD;
             to study inclusion.&#xD;
&#xD;
          2. Patients who have received previous immunotherapy treatment, both subcutaneous (SCIT)&#xD;
             and sublingual (SLIT), with any of the allergenic extracts that they plan to receive,&#xD;
             in the 5 years prior to study inclusion.&#xD;
&#xD;
          3. Patients who in the opinion of the investigator may present difficulties that prevent&#xD;
             the understanding of what was written in the informed consent form or the completion&#xD;
             of self-administered questionnaires / scales or the patient's diary.&#xD;
&#xD;
          4. Patients who are participating in another clinical trial or observational study with&#xD;
             any drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Assistencial Baix Llobregat</name>
      <address>
        <city>Cornellà De Llobregat</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Igualada</name>
      <address>
        <city>Igualada</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GAME Centre Medic</name>
      <address>
        <city>Sant Boi De Llobregat</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Hospital Calahorra</name>
      <address>
        <city>Calahorra</city>
        <state>La Rioja</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAR SAn Millán</name>
      <address>
        <city>Logroño</city>
        <state>La Rioja</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro médico Promosalud</name>
      <address>
        <city>Logroño</city>
        <state>La Rioja</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allercen</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Medic Catalonia</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital QuironSalud Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sanitas CIMA</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Allergen immunotherapy (AIT)</keyword>
  <keyword>Rhinitis</keyword>
  <keyword>Rhinoconjunctivitis</keyword>
  <keyword>Subcutaneous Immunotherapy (SCIT)</keyword>
  <keyword>Allergovac Poliplus</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>Conjunctivitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunomodulating Agents</mesh_term>
  </intervention_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/NCT03821077
org study id: ROX-ALE-2018-01
nct id: NCT03821077
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational prospective multicenter clinical study, to evaluate the efficacy and
      safety of the treatment with Allergovac Poliplus subcutaneous immunotherapy (SCIT) with a
      mixture of 2 allergenic extracts (pollens or mites), in polymerized-depot formulation,
      administered in its different available allergenic extracts mixtures (2 pollens or 2 mites),
      and in one of the 2 recommended administration schedules (1 Day or Rapid).
observational model: Cohort
time perspective: Prospective
measure: Combined Symptoms and Medication Score (CSMS)
time frame: Basal-12 months
description: The score ranged from 0 to 6 points and is obtained as follows:
Symptoms Score (SS) (from 0 to 3 points) + Medication Score (MS) (from 0 to 3 points). Through these 2 sub-scales the total score of the Combined Symptom and Medication Scale (CSMS) is obtained as follows:
CSMS = SS (0-3) + MS (0-3) = 0-6 points The 0 value indicate no symptoms and no medication, and 6 points indicate the worst state of symptoms and the highest medication step
measure: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
time frame: Basal-12 months
description: The RQLQ has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). It is a self-administered questionnaire where patients respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores reflect lower quality of life.
measure: Total number, percentage, severity and gradation of adverse reactions
time frame: Basal- 6 months-12 months
description: Total number, percentage, severity and gradation of adverse reactions reported (local and systemics), in relation to the total number of patients and the total administered doses, both globally and according to each administration schedule.
measure: Patient´s Tolerability assessment using a Likert-type scale
time frame: 6 months-12 months
description: Patient´s Tolerability assessment using a Likert-type scale, with a score of 1 to 4 points (from 1 = I have tolerated it very well to 4 = I have tolerated it very badly)
measure: Patient's perception of the improvement in their global status using a Likert-type scale
time frame: 12 months
description: Evaluation of the patient's perception of the improvement in the global state of the pathology, using a Likert-type scale, with a score of 1 to 4 points (from 1= good or excellent improvement to 4 = worsening)
measure: Patient's Satisfaction using a Likert scale
time frame: 12 months
description: Degree of patients' satisfaction with the treatment using a Likert scale, with a score of 1 to 4 points (from 1 = Very Satisfied to 4 = Very dissatisfied)
intervention type: Biological
intervention name: Allergen Immunotherapy (AIT)
description: Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation
other name: Allergovac Poliplus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Conjunctivitis
mesh term: Immunomodulating Agents
sharing ipd: No