<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/NCT01728285</url>
  </required_header>
  <id_info>
    <org_study_id>GT-17 ITALY</org_study_id>
    <secondary_id>2006-004820-35</secondary_id>
    <nct_id>NCT01728285</nct_id>
  </id_info>
  <brief_title>Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis</brief_title>
  <acronym>GT-17</acronym>
  <official_title>A Multicentric Open Randomised, Cross-over Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis</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>
      Adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic&#xD;
      diseases. GRAZAX® is a registered drug in Europe, with established efficacy in the treatment&#xD;
      of allergic rhinitis, which has to be taken daily by patients. This study was aimed to&#xD;
      establish if a device with the characteristics of a mechanical dispenser (Memozax®) could&#xD;
      improve adherence to treatment in subjects with hay fever due to allergy to grass&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2007</start_date>
  <completion_date type="Actual">October 2009</completion_date>
  <primary_completion_date type="Actual">June 2009</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate if compliance with grass Allergy Immunotherapy Tablet can be increased by providing an electronic compliance device (CED) (Memozax; a tablet-container with a programmable daily acoustic alarm)</measure>
    <time_frame>up to 1 year per patient</time_frame>
    <description>To evaluate if compliance of once daily dosing with Grazax in adult subjects with grass pollen induced allergic rhinoconjunctivitis can be increased by providing patients with an electronic compliance device. Compliance in the two groups (with Memozax and without Memozax) was evaluated by tablet counts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of GRAZAX® treatment on QoL as compared to previous season</measure>
    <time_frame>up to 1 year per patient</time_frame>
    <description>To evaluate after one-year treatment with Grazax tablets the impact on quality of life in comparison with previous pollen seasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of GRAZAX® treatment on allergy symptoms as compared to previous season</measure>
    <time_frame>up to 1 year per patient</time_frame>
    <description>To evaluate after one-year treatment with Grazax tablets the impact on symptom score in comparison with previous pollen seasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of GRAZAX® on treatment acceptance as compared to previous season</measure>
    <time_frame>up to 1 year per patient</time_frame>
    <description>To evaluate after one-year treatment with Grazax tablets the impact on patient's acceptance in comparison with previous pollen seasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recording of all adverse events and serious adverse events</measure>
    <time_frame>up to 1 year per patient</time_frame>
    <description>The safety assessments included recording of all adverse events (AE) and serious adverse events (SAE) findings from physical examinations and from vital signs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">261</enrollment>
  <condition>Allergic Rhinitis</condition>
  <condition>Grass Allergy</condition>
  <arm_group>
    <arm_group_label>Electronic compliance device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No electronic compliance device</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) without any electronic compliance device (Memozax®)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electronic compliance device (Memozax®)</intervention_name>
    <description>An electronic compliance device is distributed to patients allocated to the active arm</description>
    <arm_group_label>Electronic compliance device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A clinical history of grass pollen-induced allergic rhinoconjunctivitis (with or&#xD;
             without asthma) having received treatment during the previous grass pollen season.&#xD;
&#xD;
          -  Positive skin prick test (SPT) response (wheal diameter ≥3mm) to Phleum pratense&#xD;
&#xD;
          -  Positive specific IgE against Phleum pratense (IgE titer &gt; class 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical history of chronic sinusitis during the last 2 years or of symptomatic&#xD;
             perennial or seasonal allergic rhinitis and/or asthma having received regular&#xD;
             medication, due to another allergen during - or potentially overlapping - the grass&#xD;
             pollen season.&#xD;
&#xD;
          -  Clinical history of severe asthma (GINA Step 4 and children with Forced Expiratory&#xD;
             Volume in 1 second (FEV1) &lt; 80% of expected value after treatment with inhaled&#xD;
             corticosteroids and short-acting β2 agonists)&#xD;
&#xD;
          -  Previous treatment by immunotherapy with grass pollen allergen or any other allergen&#xD;
             within the previous 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <state>PV</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Alesina R, Milani M, Pecora S. A multicenter, randomized, parallel-group trial assessing compliance, tolerability, safety, and efficacy to treatment with grass allergy tablets in 261 patients with grass pollen rhinoconjunctivitis. J Allergy (Cairo). 2012;2012:673502. doi: 10.1155/2012/673502. Epub 2011 Nov 9.</citation>
    <PMID>22131999</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>November 14, 2012</last_update_submitted>
  <last_update_submitted_qc>November 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>specific allergen immunotherapy</keyword>
  <keyword>sublingual immunotherapy</keyword>
  <keyword>allergen tablets</keyword>
  <keyword>compliance</keyword>
  <keyword>electronic compliance device</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/NCT01728285
org study id: GT-17 ITALY
secondary id: 2006-004820-35
nct id: NCT01728285
lead sponsor: 
has dmc: No
Adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic
      diseases. GRAZAX® is a registered drug in Europe, with established efficacy in the treatment
      of allergic rhinitis, which has to be taken daily by patients. This study was aimed to
      establish if a device with the characteristics of a mechanical dispenser (Memozax®) could
      improve adherence to treatment in subjects with hay fever due to allergy to grass
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate if compliance with grass Allergy Immunotherapy Tablet can be increased by providing an electronic compliance device (CED) (Memozax; a tablet-container with a programmable daily acoustic alarm)
time frame: up to 1 year per patient
description: To evaluate if compliance of once daily dosing with Grazax in adult subjects with grass pollen induced allergic rhinoconjunctivitis can be increased by providing patients with an electronic compliance device. Compliance in the two groups (with Memozax and without Memozax) was evaluated by tablet counts
measure: Impact of GRAZAX® treatment on QoL as compared to previous season
time frame: up to 1 year per patient
description: To evaluate after one-year treatment with Grazax tablets the impact on quality of life in comparison with previous pollen seasons
measure: Impact of GRAZAX® treatment on allergy symptoms as compared to previous season
time frame: up to 1 year per patient
description: To evaluate after one-year treatment with Grazax tablets the impact on symptom score in comparison with previous pollen seasons
measure: Impact of GRAZAX® on treatment acceptance as compared to previous season
time frame: up to 1 year per patient
description: To evaluate after one-year treatment with Grazax tablets the impact on patient's acceptance in comparison with previous pollen seasons
measure: Recording of all adverse events and serious adverse events
time frame: up to 1 year per patient
description: The safety assessments included recording of all adverse events (AE) and serious adverse events (SAE) findings from physical examinations and from vital signs
arm group label: Electronic compliance device
arm group type: Active Comparator
description: Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®)
arm group label: No electronic compliance device
arm group type: No Intervention
description: Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) without any electronic compliance device (Memozax®)
intervention type: Device
intervention name: Electronic compliance device (Memozax®)
description: An electronic compliance device is distributed to patients allocated to the active arm
arm group label: Electronic compliance device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Italy
citation: Alesina R, Milani M, Pecora S. A multicenter, randomized, parallel-group trial assessing compliance, tolerability, safety, and efficacy to treatment with grass allergy tablets in 261 patients with grass pollen rhinoconjunctivitis. J Allergy (Cairo). 2012;2012:673502. doi: 10.1155/2012/673502. Epub 2011 Nov 9.
PMID: 22131999
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic