<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/NCT01734811</url>
  </required_header>
  <id_info>
    <org_study_id>MV130-SLG-002</org_study_id>
    <secondary_id>2012-002450-24</secondary_id>
    <nct_id>NCT01734811</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Evaluation in Recurrent Wheezing Attacks</brief_title>
  <acronym>MV130</acronym>
  <official_title>Randomized Double-blind Placebo-controlled, Parallel, Multi Centre Clinical Trial of Sublingual Bacterial Vaccine in Children With Recurrent Bronchospasm (Wheezing Attacks) for the Evaluation of Efficacy, Security and Clinical Impact.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inmunotek S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unidad de Investigacion Medica en Epidemiologia Clinica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Inmunotek S.L.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will be conducted in two hospitals of the same geographic area. It will be included&#xD;
      children &lt;3-years-old with recurrent wheezing attacks, confirmed by the review of the medical&#xD;
      records, in the previous 12 months or a shorter time for those younger than one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, double-blind, placebo-controlled, parallel-group study will included 120&#xD;
      children &lt;3 years old with ≥3 episodes of wheezing during the previous year. They will&#xD;
      receive active treatment or placebo for six months. The main outcome will be the number of&#xD;
      wheezing attacks during one year. Other outcomes were duration and severity of wheezing&#xD;
      attacks , symptom and medication scores, and use of health resources.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">May 2016</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>
    <intervention_model_description>Randomized, double-blind, placebo-controlled, multi centre, parallel-group study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Recurrent Bronchospasm (Wheezing Attacks)</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of reduction of bronchospasm (wheezing attacks) episodes at 12 months. The number of bronchospasm (wheezing attacks) episodes, in active and placebo group will be compared</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration (Days) of Wheezing Attacks (WA)</measure>
    <time_frame>12 months</time_frame>
    <description>Review of bronchospasm (wheezing attacks) duration per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Until Appearance of First WA</measure>
    <time_frame>12 months</time_frame>
    <description>time (days) until appearance of first wheezing attack (WA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With Wheezing Attacks During the Study</measure>
    <time_frame>12 months</time_frame>
    <description>Review of the number of days with wheezing attacks during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Recurrent WA During the Study</measure>
    <time_frame>12 months</time_frame>
    <description>Review of number of patients with recurrent WA during the whole study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Score During Wheezing Attacks</measure>
    <time_frame>12 months</time_frame>
    <description>Total of Symptom score during wheezing attacks. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.&#xD;
The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.&#xD;
The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Score During WA</measure>
    <time_frame>12 months</time_frame>
    <description>Review of medication consumption during wheezing attacks. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.&#xD;
The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Symptom Score</measure>
    <time_frame>12 months</time_frame>
    <description>Review of symptoms during the whole study. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.&#xD;
The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.&#xD;
The total symptom score was calculated as the sum of all individual scores during the whole study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Medication Score</measure>
    <time_frame>12 months</time_frame>
    <description>Review of medication consumption during the whole study. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.&#xD;
The total symptom score was calculated as the sum of all individual scores during the whole study.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Use of Health and Social Resources During the Whole Period of the Study.</measure>
    <time_frame>12 months</time_frame>
    <description>The use of health and social resources during the study was also recorded: days of hospitalization in ward and/or intensive care unit, visits to the emergency units, unscheduled visits to the pediatrician and/or to the specialist, telephone calls to the pediatrician, complementary tests (chest radiogram, blood analysis, others), days of school absenteeism and caregiver-days when the children needed them. The data were obtained from the diary cards and confirmed through the review of medical records.&#xD;
Maximum value corresponds to the maximum days spent in health resources (specified above) and the minimum value corresponds to the minimum of days spent in health resources (specified above)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Bronchospasm; Bronchiolitis</condition>
  <condition>Bronchospasm; Bronchitis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biological vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Biological vaccine</intervention_name>
    <description>daily spray (2 puff of 100 µL) for six months</description>
    <arm_group_label>Biological vaccine</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects whose parents /legal representative have given written informed consent.&#xD;
&#xD;
          -  Both gender&#xD;
&#xD;
          -  Subject up to 36 months of age.&#xD;
&#xD;
          -  Subjects with recurrent bronchospasms (wheezing attacks); 3 or more exacerbations in&#xD;
             the last 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects whose parents/legal representative have not given written informed consent.&#xD;
&#xD;
          -  Subjects out of aged range&#xD;
&#xD;
          -  Subjects with malignancies or chemotherapy treatment&#xD;
&#xD;
          -  Subjects included in another clinical trial in the last 12 months.&#xD;
&#xD;
          -  Subject in immunosuppressive or immunostimulatory treatment&#xD;
&#xD;
          -  Subjects who have received iv gamma globulin in the past 12 months.&#xD;
&#xD;
          -  Subjects diagnosed with candidiasis or fungal recurrent infections.&#xD;
&#xD;
          -  Subjects diagnosed with malabsorption syndrome&#xD;
&#xD;
          -  Subjects with clinical allergy to common aeroallergens in the geographical area.&#xD;
&#xD;
          -  Subjects with hepatitis virus infections, HIV and tuberculosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miguel Casanovas, PhD; MD</last_name>
    <role>Study Director</role>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Manises</name>
      <address>
        <city>Manises</city>
        <state>Valencia</state>
        <zip>46940</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politécnico La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Alecsandru D, Valor L, Sanchez-Ramon S, Gil J, Carbone J, Navarro J, Rodriguez J, Rodriguez-Sainz C, Fernandez-Cruz E. Sublingual therapeutic immunization with a polyvalent bacterial preparation in patients with recurrent respiratory infections: immunomodulatory effect on antigen-specific memory CD4+ T cells and impact on clinical outcome. Clin Exp Immunol. 2011 Apr;164(1):100-7. doi: 10.1111/j.1365-2249.2011.04320.x.</citation>
    <PMID>21391984</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>May 28, 2020</results_first_submitted>
  <results_first_submitted_qc>August 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 4, 2020</results_first_posted>
  <last_update_submitted>November 4, 2021</last_update_submitted>
  <last_update_submitted_qc>November 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaccine</keyword>
  <keyword>Bronchospasm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Bronchial Spasm</mesh_term>
    <mesh_term>Respiratory Sounds</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>October 2012 - May 2015 subjects enrollment. 120 children &lt;3 years old with recurrent WA, defined as 3 or more episodes of WA during the previous year. . WA were confirmed by the review of the medical records. Aeroallergen sensitization at baseline was used as an exclusion criterion to avoid an eventual WA due to allergic asthma.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
        </group>
        <group group_id="P2">
          <title>Biological Vaccine</title>
          <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>&lt;3 years old with recurrent WA, defined as 3 or more episodes of WA during the previous year.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
        </group>
        <group group_id="B2">
          <title>Biological Vaccine</title>
          <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</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="58"/>
            <count group_id="B2" value="62"/>
            <count group_id="B3" value="120"/>
          </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="58"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 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>
                  <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>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23" spread="8"/>
                    <measurement group_id="B2" value="23" spread="7"/>
                    <measurement group_id="B3" value="23" spread="8"/>
                  </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="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="69"/>
                  </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>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Recurrent Bronchospasm (Wheezing Attacks)</title>
        <description>Assessment of reduction of bronchospasm (wheezing attacks) episodes at 12 months. The number of bronchospasm (wheezing attacks) episodes, in active and placebo group will be compared</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Recurrent Bronchospasm (Wheezing Attacks)</title>
          <description>Assessment of reduction of bronchospasm (wheezing attacks) episodes at 12 months. The number of bronchospasm (wheezing attacks) episodes, in active and placebo group will be compared</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299"/>
                    <measurement group_id="O2" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration (Days) of Wheezing Attacks (WA)</title>
        <description>Review of bronchospasm (wheezing attacks) duration per patient</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Duration (Days) of Wheezing Attacks (WA)</title>
          <description>Review of bronchospasm (wheezing attacks) duration per patient</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" lower_limit="6.2" upper_limit="11.0"/>
                    <measurement group_id="O2" value="6.0" lower_limit="4.0" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Until Appearance of First WA</title>
        <description>time (days) until appearance of first wheezing attack (WA)</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Time Until Appearance of First WA</title>
          <description>time (days) until appearance of first wheezing attack (WA)</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="2.0" upper_limit="28.8"/>
                    <measurement group_id="O2" value="41.0" lower_limit="15.0" upper_limit="94.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With Wheezing Attacks During the Study</title>
        <description>Review of the number of days with wheezing attacks during the study</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With Wheezing Attacks During the Study</title>
          <description>Review of the number of days with wheezing attacks during the study</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0" lower_limit="17.0" upper_limit="57.5"/>
                    <measurement group_id="O2" value="19.2" lower_limit="8.5" upper_limit="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Recurrent WA During the Study</title>
        <description>Review of number of patients with recurrent WA during the whole study</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Recurrent WA During the Study</title>
          <description>Review of number of patients with recurrent WA during the whole study</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptom Score During Wheezing Attacks</title>
        <description>Total of Symptom score during wheezing attacks. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.&#xD;
The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.&#xD;
The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Score During Wheezing Attacks</title>
          <description>Total of Symptom score during wheezing attacks. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.&#xD;
The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.&#xD;
The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155.0" lower_limit="79.0" upper_limit="244.5"/>
                    <measurement group_id="O2" value="80.0" lower_limit="19.5" upper_limit="154.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Score During WA</title>
        <description>Review of medication consumption during wheezing attacks. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.&#xD;
The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Score During WA</title>
          <description>Review of medication consumption during wheezing attacks. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.&#xD;
The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="424.0" lower_limit="185.0" upper_limit="738.5"/>
                    <measurement group_id="O2" value="164.0" lower_limit="43.5" upper_limit="311.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Symptom Score</title>
        <description>Review of symptoms during the whole study. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.&#xD;
The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.&#xD;
The total symptom score was calculated as the sum of all individual scores during the whole study</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Symptom Score</title>
          <description>Review of symptoms during the whole study. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.&#xD;
The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.&#xD;
The total symptom score was calculated as the sum of all individual scores during the whole study</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="421.0" lower_limit="303.0" upper_limit="673.0"/>
                    <measurement group_id="O2" value="276.5" lower_limit="151.0" upper_limit="426.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Medication Score</title>
        <description>Review of medication consumption during the whole study. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.&#xD;
The total symptom score was calculated as the sum of all individual scores during the whole study.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Medication Score</title>
          <description>Review of medication consumption during the whole study. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.&#xD;
Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.&#xD;
The total symptom score was calculated as the sum of all individual scores during the whole study.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1043.5" lower_limit="669.5" upper_limit="1696.0"/>
                    <measurement group_id="O2" value="618.5" lower_limit="318.3" upper_limit="1035.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Use of Health and Social Resources During the Whole Period of the Study.</title>
        <description>The use of health and social resources during the study was also recorded: days of hospitalization in ward and/or intensive care unit, visits to the emergency units, unscheduled visits to the pediatrician and/or to the specialist, telephone calls to the pediatrician, complementary tests (chest radiogram, blood analysis, others), days of school absenteeism and caregiver-days when the children needed them. The data were obtained from the diary cards and confirmed through the review of medical records.&#xD;
Maximum value corresponds to the maximum days spent in health resources (specified above) and the minimum value corresponds to the minimum of days spent in health resources (specified above)</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
          <group group_id="O2">
            <title>Biological Vaccine</title>
            <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Health and Social Resources During the Whole Period of the Study.</title>
          <description>The use of health and social resources during the study was also recorded: days of hospitalization in ward and/or intensive care unit, visits to the emergency units, unscheduled visits to the pediatrician and/or to the specialist, telephone calls to the pediatrician, complementary tests (chest radiogram, blood analysis, others), days of school absenteeism and caregiver-days when the children needed them. The data were obtained from the diary cards and confirmed through the review of medical records.&#xD;
Maximum value corresponds to the maximum days spent in health resources (specified above) and the minimum value corresponds to the minimum of days spent in health resources (specified above)</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="2" upper_limit="52"/>
                    <measurement group_id="O2" value="11.0" lower_limit="0" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 12 months.</time_frame>
      <desc>Adverse Events were registered throughout the trial. Grading was according to EAACI guidelines.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
        </group>
        <group group_id="E2">
          <title>Biological Vaccine</title>
          <description>The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation&#xD;
Biological vaccine: daily spray (2 puff of 100 µL) for six months</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epilectic seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
              </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>Medical Director</name_or_title>
      <organization>Inmunotek</organization>
      <phone>916 510 010</phone>
      <email>mcasanovas@inmunotek.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/NCT01734811
org study id: MV130-SLG-002
secondary id: 2012-002450-24
nct id: NCT01734811
lead sponsor: 
collaborator: 
has dmc: No
The study will be conducted in two hospitals of the same geographic area. It will be included
      children <3-years-old with recurrent wheezing attacks, confirmed by the review of the medical
      records, in the previous 12 months or a shorter time for those younger than one year.
This randomized, double-blind, placebo-controlled, parallel-group study will included 120
      children <3 years old with ≥3 episodes of wheezing during the previous year. They will
      receive active treatment or placebo for six months. The main outcome will be the number of
      wheezing attacks during one year. Other outcomes were duration and severity of wheezing
      attacks , symptom and medication scores, and use of health resources.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Number of Recurrent Bronchospasm (Wheezing Attacks)
time frame: 12 months
description: Assessment of reduction of bronchospasm (wheezing attacks) episodes at 12 months. The number of bronchospasm (wheezing attacks) episodes, in active and placebo group will be compared
measure: Duration (Days) of Wheezing Attacks (WA)
time frame: 12 months
description: Review of bronchospasm (wheezing attacks) duration per patient
measure: Time Until Appearance of First WA
time frame: 12 months
description: time (days) until appearance of first wheezing attack (WA)
measure: Number of Days With Wheezing Attacks During the Study
time frame: 12 months
description: Review of the number of days with wheezing attacks during the study
measure: Number of Patients With Recurrent WA During the Study
time frame: 12 months
description: Review of number of patients with recurrent WA during the whole study
measure: Symptom Score During Wheezing Attacks
time frame: 12 months
description: Total of Symptom score during wheezing attacks. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.
Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.
The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.
The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.
measure: Medication Score During WA
time frame: 12 months
description: Review of medication consumption during wheezing attacks. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.
Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.
The total symptom score was calculated as the sum of all individual scores during the wheezing attacks.
measure: Overall Symptom Score
time frame: 12 months
description: Review of symptoms during the whole study. The patients were reviewed at our clinics every three months. These scores were recorded daily in a diary card by the parents, who were duly instructed.
Scale use to evaluate symptom during wheezing attacks is called the Symptom scores (SS) scale. Minimum value is 0 (meant improvement) and maximum value (meant not improvement) is 3.
The rating was: 0=absent (no sign/symptom evident); 1=mild (sign/symptom clearly present, but easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable) and 3=severe (sign/symptom that is hard to tolerate; causes interference with activities of daily life and/or sleeping). Fever was scored as number of days with temperature over 37ºC.
The total symptom score was calculated as the sum of all individual scores during the whole study
measure: Overall Medication Score
time frame: 12 months
description: Review of medication consumption during the whole study. The patients were reviewed at our clinics every three months. Medication scores were recorded daily in a diary card by the parents, who were duly instructed.
Medication was rated from 0 (minimum value) and the maximum value correspond to the maximum medication consumed per 24h. Rating was according to Dreborg et al. with slight modifications: two points were given for one tablet of 4 mg of Montelukast, for one puff of 50 μg budesonide-equivalent or for one dose of oral prednisolone, and 3 for the inhalation of one puff of 200 μg budesonide-equivalent. In the case of antibiotics and antipyretic/-anti-inflammatory drugs, the number of daily doses of these drugs was recorded.
The total symptom score was calculated as the sum of all individual scores during the whole study.
measure: Use of Health and Social Resources During the Whole Period of the Study.
time frame: 12 months
description: The use of health and social resources during the study was also recorded: days of hospitalization in ward and/or intensive care unit, visits to the emergency units, unscheduled visits to the pediatrician and/or to the specialist, telephone calls to the pediatrician, complementary tests (chest radiogram, blood analysis, others), days of school absenteeism and caregiver-days when the children needed them. The data were obtained from the diary cards and confirmed through the review of medical records.
Maximum value corresponds to the maximum days spent in health resources (specified above) and the minimum value corresponds to the minimum of days spent in health resources (specified above)
arm group label: Placebo
arm group type: Placebo Comparator
description: The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation
arm group label: Biological vaccine
arm group type: Experimental
description: The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation
intervention type: Biological
intervention name: Biological vaccine
description: daily spray (2 puff of 100 µL) for six months
arm group label: Biological vaccine
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Months
maximum age: 36 Months
healthy volunteers: No
last name: Miguel Casanovas, PhD; MD
role: Study Director
facility: 
facility: 
country: Spain
citation: Alecsandru D, Valor L, Sanchez-Ramon S, Gil J, Carbone J, Navarro J, Rodriguez J, Rodriguez-Sainz C, Fernandez-Cruz E. Sublingual therapeutic immunization with a polyvalent bacterial preparation in patients with recurrent respiratory infections: immunomodulatory effect on antigen-specific memory CD4+ T cells and impact on clinical outcome. Clin Exp Immunol. 2011 Apr;164(1):100-7. doi: 10.1111/j.1365-2249.2011.04320.x.
PMID: 21391984
responsible party type: Sponsor
mesh term: Bronchiolitis
mesh term: Bronchitis
mesh term: Bronchial Spasm
mesh term: Respiratory Sounds
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 