<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/NCT02245360</url>
  </required_header>
  <id_info>
    <org_study_id>GRAS3001</org_study_id>
    <nct_id>NCT02245360</nct_id>
  </id_info>
  <brief_title>Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the SQ Grass SLIT-tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the immunologic effects and safety of 60-day treatment of the Standardized&#xD;
      Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass&#xD;
      pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum</measure>
    <time_frame>baseline versus end of treatment (approx. 60 days)</time_frame>
    <description>measurement of IgG4 in serum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment</measure>
    <time_frame>baseline versus end of treatment (approx. 60 days)</time_frame>
    <description>measurement of IgE in serum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Seasonal Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Grass tablet 75,000 SQ-T</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phleum pratense grass pollen allergen extract</intervention_name>
    <description>Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days</description>
    <arm_group_label>Grass tablet 75,000 SQ-T</arm_group_label>
    <other_name>GRAZAX/GRASTEK</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo tablet given once daily over 60 days</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.&#xD;
&#xD;
          -  Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.&#xD;
&#xD;
          -  Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.&#xD;
&#xD;
          -  If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram&#xD;
             budesonide or equivalent&#xD;
&#xD;
          -  Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined&#xD;
             as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reduced lung function (defined as FEV1 &lt; 70% (FEV1=Forced Expiratory Volume in 1&#xD;
             second) of predicted value after adequate pharmacologic treatment) measured at Visit 1&#xD;
             and Visit 2&#xD;
&#xD;
          -  Clinical history of uncontrolled asthma within 3 months prior to the screening visit&#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>Dmitri Kazei, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research facility ID ORG-001086</name>
      <address>
        <city>Moscow</city>
        <zip>105077</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001018</name>
      <address>
        <city>Moscow</city>
        <zip>115446</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001005</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001009</name>
      <address>
        <city>Moscow</city>
        <zip>119333</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001016</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001006</name>
      <address>
        <city>Moscow</city>
        <zip>123182</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001085</name>
      <address>
        <city>Moscow</city>
        <zip>123182</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001014</name>
      <address>
        <city>Moscow</city>
        <zip>142190</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001015</name>
      <address>
        <city>Samara</city>
        <zip>443099</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001021</name>
      <address>
        <city>Saratov</city>
        <zip>410028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001017</name>
      <address>
        <city>Smolensk</city>
        <zip>214019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001007</name>
      <address>
        <city>St. Petersburg</city>
        <zip>193231</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001019</name>
      <address>
        <city>St. Petersburg</city>
        <zip>195030</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001008</name>
      <address>
        <city>St. Petersburg</city>
        <zip>198216</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001020</name>
      <address>
        <city>Ufa</city>
        <zip>450000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>November 3, 2015</results_first_submitted>
  <results_first_submitted_qc>November 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 8, 2015</results_first_posted>
  <last_update_submitted>December 9, 2015</last_update_submitted>
  <last_update_submitted_qc>December 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GRAZAX</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>Rhinitis, Allergic, Seasonal</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Grass Tablet 75,000 SQ-T</title>
          <description>Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)&#xD;
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo&#xD;
placebo: placebo tablet given once daily over 60 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Grass Tablet 75,000 SQ-T</title>
          <description>Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)&#xD;
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo&#xD;
placebo: placebo tablet given once daily over 60 days</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="107"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.8" spread="11.2"/>
                    <measurement group_id="B2" value="34.1" spread="10.1"/>
                    <measurement group_id="B3" value="34.9" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Russian Federation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum</title>
        <description>measurement of IgG4 in serum</description>
        <time_frame>baseline versus end of treatment (approx. 60 days)</time_frame>
        <population>In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>Grass Tablet 75,000 SQ-T</title>
            <description>Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)&#xD;
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
placebo: placebo tablet given once daily over 60 days</description>
          </group>
        </group_list>
        <measure>
          <title>The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum</title>
          <description>measurement of IgG4 in serum</description>
          <population>In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.</population>
          <units>mgA/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.684" spread="1.691"/>
                    <measurement group_id="O2" value="0.050" spread="0.588"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment</title>
        <description>measurement of IgE in serum</description>
        <time_frame>baseline versus end of treatment (approx. 60 days)</time_frame>
        <population>In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.</population>
        <group_list>
          <group group_id="O1">
            <title>Grass Tablet 75,000 SQ-T</title>
            <description>Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)&#xD;
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
placebo: placebo tablet given once daily over 60 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment</title>
          <description>measurement of IgE in serum</description>
          <population>In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.</population>
          <units>UA/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.751" spread="29.364"/>
                    <measurement group_id="O2" value="-2.756" spread="16.933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Grass Tablet 75,000 SQ-T</title>
          <description>Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)&#xD;
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo&#xD;
placebo: placebo tablet given once daily over 60 days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oral pruritus</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Tongue oedema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="53"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dmitri Kazei MD, PhD</name_or_title>
      <organization>Abbott</organization>
      <phone>+31 294477008</phone>
      <email>dmitri.kazei@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02245360
org study id: GRAS3001
nct id: NCT02245360
lead sponsor: 
has dmc: No
To investigate the immunologic effects and safety of 60-day treatment of the Standardized
      Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass
      pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
time frame: baseline versus end of treatment (approx. 60 days)
description: measurement of IgG4 in serum
measure: Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
time frame: baseline versus end of treatment (approx. 60 days)
description: measurement of IgE in serum
arm group label: Grass tablet 75,000 SQ-T
arm group type: Experimental
description: Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Phleum pratense grass pollen allergen extract
description: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
arm group label: Grass tablet 75,000 SQ-T
other name: GRAZAX/GRASTEK
intervention type: Drug
intervention name: placebo
description: placebo tablet given once daily over 60 days
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dmitri Kazei, MD PhD
role: Study Director
affiliation: Abbott
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country: Russian Federation
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal
participant flow: 
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reported events: 
certain agreements: 
point of contact: 