<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/NCT04435990</url>
  </required_header>
  <id_info>
    <org_study_id>MM09-SIT-023</org_study_id>
    <secondary_id>2018-004262-34</secondary_id>
    <nct_id>NCT04435990</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites</brief_title>
  <acronym>MM09-SIT-023</acronym>
  <official_title>Randomized, Double-blinded, Placebo-controlled, Prospective, Multicenter Trial to Evaluate the Efficacy and Safety of SIC in Subjects With Mild/Moderate Asthma and Rhinitis/Rhinoconjunctivitis Sensitized to D.Pteronyssinus and/or D. Farinae</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inmunotek S.L.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BioClever 2005 S.L.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Inmunotek S.L.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active&#xD;
      treatment groups, compared to 1 placebo group, for the determination of the efficacy and&#xD;
      safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with mild&#xD;
      to moderate asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides&#xD;
      farinae.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects&#xD;
      sensitised to mites, from 14 to 65 years of age. Medication treatment of 1 year. The main&#xD;
      outcome: CSMS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 6, 2020</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving.&#xD;
The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed.&#xD;
So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CSMS: Combined Symptoms and Medication Score</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in asthma and rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication-free days</measure>
    <time_frame>12 months</time_frame>
    <description>Number of days that the subjects need no medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom-free days</measure>
    <time_frame>12 months</time_frame>
    <description>Number of days that the subjects have no symptom</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by MM09-SIT-023</measure>
    <time_frame>12 months</time_frame>
    <description>Comparison between the beginning and end of the trial and among active groups and placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life associated with asthma</measure>
    <time_frame>12 months</time_frame>
    <description>The quality of life associated with asthma will be measured following the GINA questionnaire.&#xD;
The GINA questionnaire consists of 4 questions. In questions 1-4, patients recall their experience during the last 4 weeks and answer using YES or NO.&#xD;
The interpretation of the answers is as follows:&#xD;
Well-controlled: None of the answers are YES Partly controlled: 1 - 2 answers are YES Uncontrolled: 3-4 answers are YES</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life associated with rhinitis</measure>
    <time_frame>12 months</time_frame>
    <description>The quality of life associated with rhinitis will be measured following the test ESPRINT-15.&#xD;
The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from &quot;0 = nothing has bothered me&quot; to &quot;6 = it has bothered me a lot&quot;) of the 14 items plus the score given in the general questionnaire (ranging from &quot;0 = Excellent&quot; to &quot;4 = Bad&quot;). This sum is divided by the total number of items (15 items).&#xD;
The interpretation of the scores is between 0 (low impact) and 6 (high impact).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>12 months</time_frame>
    <description>Visual Analogue Scale in which the subject has to indicate how he/she feels regarding to his allergy symptoms at the moment from 1 to 10. Being 1 very bad and 10 very well.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunological parameters</measure>
    <time_frame>12 months</time_frame>
    <description>Analyses of total Ig3 and specific IgA,IgG and IgG4</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Rhinitis, Allergic</condition>
  <condition>Rhinoconjunctivitis</condition>
  <condition>Asthma, Allergic</condition>
  <arm_group>
    <arm_group_label>Experimental:10,000 MM09</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10,000 TU/mL of subcutaneous immunotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: 30,000 MM09</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30,000 TU/mL of subcutaneous immunotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo subcutaneous</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The same solution and presentation as the active treatment, but without any active ingredients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>10,000 MM09</intervention_name>
    <description>Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL</description>
    <arm_group_label>Experimental:10,000 MM09</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>30,000 MM09</intervention_name>
    <description>Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL</description>
    <arm_group_label>Experimental: 30,000 MM09</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo subcutaneous</intervention_name>
    <description>The same solution and presentation as the active treatment, but without active ingredients.</description>
    <arm_group_label>Placebo subcutaneous</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
          -  Age between 14 and 65, both genders.&#xD;
&#xD;
          -  Positive suggestive clinical history of controlled intermittent or persistent asthma&#xD;
             with intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, due&#xD;
             to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of&#xD;
             asthma will be valid from 12 months prior to signing the informed consent form&#xD;
&#xD;
          -  Subjects with a positive skin prick-test wheal size &gt;5 mm higher diameter due to&#xD;
             Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and&#xD;
             negative control of the test should give consistent results&#xD;
&#xD;
          -  Specific immunoglobulin E against house dust mites &gt;3,5 KU/mL (InmunoCAP® o Immulite),&#xD;
             for the complete extract of Dermatophagoides pteronyssinus and / or for&#xD;
             Dermatophagoides farinae or for some of the molecular components of these allergenic&#xD;
             sources&#xD;
&#xD;
          -  Subjects should preferably be monosensitized to the study allergens. In case of&#xD;
             subjects sensitized to other aeroallergens, only those with the following&#xD;
             characteristics may be included in the study:&#xD;
&#xD;
               -  Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus&#xD;
                  destructor, whose specific IgE values do not exceed or equal the values for the&#xD;
                  study allergens. The maximum specific IgE value for these allergens is 3.5 KU/L.&#xD;
&#xD;
               -  Subjects with positive skin tests to epithelia, as long as they present&#xD;
                  occasional exposure and symptomatology.&#xD;
&#xD;
               -  Subjects with positive skin tests to pollens, whose specific IgE values do not&#xD;
                  exceed or equal the values of the allergens in the study and who do not present&#xD;
                  exacerbations during the pollen season. The maximum value of specific IgE for&#xD;
                  these allergens is 17.5 KU/L.&#xD;
&#xD;
          -  Women of childbearing age (from menarche) must present a urine pregnancy test with a&#xD;
             negative result at the time of joining the trial, before the first administration of&#xD;
             the IMP.&#xD;
&#xD;
          -  Women of childbearing age participating in the trial must agree to use an appropriate&#xD;
             method of contraception, meaning any act, device, or medication to prevent conception&#xD;
             or viable pregnancy, during the trial if they are sexually active.&#xD;
&#xD;
          -  Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.&#xD;
&#xD;
          -  Subjects capable of complying with the dosing regimen.&#xD;
&#xD;
          -  Subjects who own an smartphone for symptom registration and medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with positive prick test to fungus, whose specific IgE is &lt;0,35 KU/L&#xD;
&#xD;
          -  Subjects with positive prick test to epiteliums, whose specific IgE is &lt;0,35 KU/L&#xD;
&#xD;
          -  Subjects who have received prior immunotherapy in the preceding 5 years for any of the&#xD;
             epiteliums, fungus and dust mites.&#xD;
&#xD;
          -  Subjects in which immunotherapy may be subject to an absolute general contraindication&#xD;
             according to the criteria of the Immunotherapy Committee of the Spanish Society of&#xD;
             Allergy and Clinical Immunology and the European Allergy and Clinical Immunology&#xD;
             Immunotherapy Subcommittee.&#xD;
&#xD;
          -  Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1&#xD;
             &lt;70% with respect to the reference value despite adequate pharmacological treatment at&#xD;
             the time of inclusion in the trial. Likewise, subjects with intermittent or persistent&#xD;
             rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or&#xD;
             systemic antihistamine treatment is contraindicated.&#xD;
&#xD;
          -  Subjects who have previously presented a serious secondary reaction during the&#xD;
             performance of diagnostic skin tests using the prick test.&#xD;
&#xD;
          -  Subjects under treatment with β-blockers.&#xD;
&#xD;
          -  Clinically unstable subjects at the time of inclusion in the trial (acute asthma&#xD;
             exacerbation, respiratory infection, feverish process, acute urticaria, etc.).&#xD;
&#xD;
          -  Subjects with active chronic urticaria, severe dermography, severe atopic dermatitis,&#xD;
             sunburn, active psoriasis with lesions in areas where skin tests are performed, or a&#xD;
             history of hereditary angioedema.&#xD;
&#xD;
          -  Subjects that have some pathology in which the administration of adrenaline is&#xD;
             contraindicated (hyperthyroidism, hypertension, heart disease, etc.).&#xD;
&#xD;
          -  Subjects with some other disease not related to moderate rhinoconjunctivitis or&#xD;
             asthma, but of potential severity and that may interfere with treatment and follow-up&#xD;
             (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multiple&#xD;
             operations, kidney disease,).&#xD;
&#xD;
          -  Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a&#xD;
             diagnosis of immunodeficiencies.&#xD;
&#xD;
          -  Subject whose status prevents him from offering cooperation and or who has severe&#xD;
             psychiatric disorders.&#xD;
&#xD;
          -  Subjects with a known allergy to other components of the investigational medicinal&#xD;
             product other than the allergen.&#xD;
&#xD;
          -  Subjects with diseases of the lower respiratory tract other than asthma such as&#xD;
             emphysema or bronchiectasis.&#xD;
&#xD;
          -  Direct investigator's relatives.&#xD;
&#xD;
          -  Pregnant women or breastfeeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Pujadas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quirón Palma de Mallorca</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mario Tubella, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cenvi Medic, Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alfonso Malet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allergocentre, Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miguel Ángel Añó, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alergocantabria, Santander</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miguel Herrías, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinica Privada Bilbao</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonio Letrán, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital HLA Jeréz Puerta del Sur</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Diego Gutiérrez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clínica Virgen del Rosario, Algeciras</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ignacio Garcia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinica Quirón Salud, Córdoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manuel Barceló, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinica Privada, Málaga.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mº José Pereira, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Médico Puerto, Jerez</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Isabella Raducán, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clínica TECMA, Alzira</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Noelia Colomer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clínica IMED, Valencia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eugenia Margarita Campos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clínica IMED, Elche</affiliation>
  </overall_official>
  <overall_official>
    <last_name>César Alías, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clínica Corachan, Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joaquín Martín, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital POLUSA, Lugo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francisco Moreno, MD</last_name>
    <phone>956292100</phone>
    <phone_ext>+34</phone_ext>
    <email>dr.moreno@drlobaton.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Miguel Casanovas, MD PhD</last_name>
    <phone>916510010</phone>
    <phone_ext>+34</phone_ext>
    <email>mcasanovas@inmunotek.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IMED Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Eugenia Margarita Campos, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinica Virgen del Rosario</name>
      <address>
        <city>Algeciras</city>
        <state>Cadiz</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Dexeus</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluña</state>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elena Botey, DM</last_name>
    </contact>
    <investigator>
      <last_name>Begoña Navarro, DM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clínica Dermatológica y Alergia</name>
      <address>
        <city>Badajoz</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Irán Sánchez, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Zafra</name>
      <address>
        <city>Badajoz</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Silvia Sánchez, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Allergocenter</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cenvi Medic</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clínica Corachan</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>César Alías, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinica privada</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro Médico ASISA Dr. Lobatón</name>
      <address>
        <city>Cadiz</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Francisco Moreno, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centro Médico Puerto</name>
      <address>
        <city>Cadiz</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron Salud Córdoba</name>
      <address>
        <city>Córdoba</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ignacio Garcia Núñez, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital HLA Jerez Puerta Sur</name>
      <address>
        <city>Jerez De La Frontera</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Polusa</name>
      <address>
        <city>Lugo</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Joaquín Martín, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinica privada</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Manuel Barceló Muñoz, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alergocantabria</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinica IMED</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Rivera Povisa</name>
      <address>
        <city>Vigo</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Carmen Mogío, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Piacentini GL, Vicentini L, Mazzi P, Chilosi M, Martinati L, Boner AL. Mite-antigen avoidance can reduce bronchial epithelial shedding in allergic asthmatic children. Clin Exp Allergy. 1998 May;28(5):561-7. doi: 10.1046/j.1365-2222.1998.00260.x.</citation>
    <PMID>9645592</PMID>
  </reference>
  <reference>
    <citation>Yepes-Nunez JJ, Gomez C, Espinoza Y, Cardona R. [The impact of subcutaneous immunotherapy with Dermatophagoides farinae and Dermatophagoides pteronyssinus on the quality of life of patients with allergic rhinitis and asthma]. Biomedica. 2014 Apr-Jun;34(2):282-90. doi: 10.1590/S0120-41572014000200014. Spanish.</citation>
    <PMID>24967933</PMID>
  </reference>
  <reference>
    <citation>Cardona R, Lopez E, Beltran J, Sanchez J. Safety of immunotherapy in patients with rhinitis, asthma or atopic dermatitis using an ultra-rush buildup. A retrospective study. Allergol Immunopathol (Madr). 2014 Mar-Apr;42(2):90-5. doi: 10.1016/j.aller.2012.07.005. Epub 2012 Dec 20.</citation>
    <PMID>23265265</PMID>
  </reference>
  <reference>
    <citation>Bousquet J, Hejjaoui A, Clauzel AM, Guerin B, Dhivert H, Skassa-Brociek W, Michel FB. Specific immunotherapy with a standardized Dermatophagoides pteronyssinus extract. II. Prediction of efficacy of immunotherapy. J Allergy Clin Immunol. 1988 Dec;82(6):971-7. doi: 10.1016/0091-6749(88)90133-9.</citation>
    <PMID>3204255</PMID>
  </reference>
  <reference>
    <citation>Branco Ferreira M, Spinola Santos A, Pereira Santos MC, Palma Carlos ML, Pereira Barbosa MA, Palma Carlos AG. Efficacy and safety of specific immunotherapy with a modified mite extract. Allergol Immunopathol (Madr). 2005 Mar-Apr;33(2):80-5. doi: 10.1157/13072918.</citation>
    <PMID>15808114</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rhinitis/ Rhinoconjunctivitis</keyword>
  <keyword>Mild to moderate asthma</keyword>
  <keyword>Allergy</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Mites</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435990
org study id: MM09-SIT-023
secondary id: 2018-004262-34
nct id: NCT04435990
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active
      treatment groups, compared to 1 placebo group, for the determination of the efficacy and
      safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with mild
      to moderate asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides
      farinae.
Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects
      sensitised to mites, from 14 to 65 years of age. Medication treatment of 1 year. The main
      outcome: CSMS
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, placebo-controlled, multi centre, parallel-group study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving.
The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed.
So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.
measure: CSMS: Combined Symptoms and Medication Score
time frame: 12 months
description: Evaluation of the number of symptoms and the consumption of medication necessary for the control of such symptoms in asthma and rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.
measure: Medication-free days
time frame: 12 months
description: Number of days that the subjects need no medication
measure: Symptom-free days
time frame: 12 months
description: Number of days that the subjects have no symptom
measure: Number of participants with treatment-related adverse events as assessed by MM09-SIT-023
time frame: 12 months
description: Comparison between the beginning and end of the trial and among active groups and placebo
measure: Quality of life associated with asthma
time frame: 12 months
description: The quality of life associated with asthma will be measured following the GINA questionnaire.
The GINA questionnaire consists of 4 questions. In questions 1-4, patients recall their experience during the last 4 weeks and answer using YES or NO.
The interpretation of the answers is as follows:
Well-controlled: None of the answers are YES Partly controlled: 1 - 2 answers are YES Uncontrolled: 3-4 answers are YES
measure: Quality of life associated with rhinitis
time frame: 12 months
description: The quality of life associated with rhinitis will be measured following the test ESPRINT-15.
The scoring of the questionnaire will be carried out as follows: The global sum of the scores (ranging from "0 = nothing has bothered me" to "6 = it has bothered me a lot") of the 14 items plus the score given in the general questionnaire (ranging from "0 = Excellent" to "4 = Bad"). This sum is divided by the total number of items (15 items).
The interpretation of the scores is between 0 (low impact) and 6 (high impact).
measure: Visual Analogue Scale (VAS)
time frame: 12 months
description: Visual Analogue Scale in which the subject has to indicate how he/she feels regarding to his allergy symptoms at the moment from 1 to 10. Being 1 very bad and 10 very well.
measure: Immunological parameters
time frame: 12 months
description: Analyses of total Ig3 and specific IgA,IgG and IgG4
arm group label: Experimental:10,000 MM09
arm group type: Experimental
description: 10,000 TU/mL of subcutaneous immunotherapy
arm group label: Experimental: 30,000 MM09
arm group type: Experimental
description: 30,000 TU/mL of subcutaneous immunotherapy
arm group label: Placebo subcutaneous
arm group type: Placebo Comparator
description: The same solution and presentation as the active treatment, but without any active ingredients.
intervention type: Biological
intervention name: 10,000 MM09
description: Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
arm group label: Experimental:10,000 MM09
intervention type: Biological
intervention name: 30,000 MM09
description: Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
arm group label: Experimental: 30,000 MM09
intervention type: Biological
intervention name: Placebo subcutaneous
description: The same solution and presentation as the active treatment, but without active ingredients.
arm group label: Placebo subcutaneous
criteria: 
gender: All
minimum age: 14 Years
maximum age: 65 Years
healthy volunteers: No
last name: Daniel Pujadas, MD
role: Principal Investigator
affiliation: Quirón Palma de Mallorca
last name: Mario Tubella, MD
role: Principal Investigator
affiliation: Cenvi Medic, Barcelona
last name: Alfonso Malet, MD
role: Principal Investigator
affiliation: Allergocentre, Barcelona
last name: Miguel Ángel Añó, MD
role: Principal Investigator
affiliation: Alergocantabria, Santander
last name: Miguel Herrías, MD
role: Principal Investigator
affiliation: Clinica Privada Bilbao
last name: Antonio Letrán, MD
role: Principal Investigator
affiliation: Hospital HLA Jeréz Puerta del Sur
last name: Diego Gutiérrez, MD
role: Principal Investigator
affiliation: Clínica Virgen del Rosario, Algeciras
last name: Ignacio Garcia, MD
role: Principal Investigator
affiliation: Clinica Quirón Salud, Córdoba
last name: Manuel Barceló, MD
role: Principal Investigator
affiliation: Clinica Privada, Málaga.
last name: Mº José Pereira, MD
role: Principal Investigator
affiliation: Centro Médico Puerto, Jerez
last name: Isabella Raducán, MD
role: Principal Investigator
affiliation: Clínica TECMA, Alzira
last name: Noelia Colomer, MD
role: Principal Investigator
affiliation: Clínica IMED, Valencia
last name: Eugenia Margarita Campos, MD
role: Principal Investigator
affiliation: Clínica IMED, Elche
last name: César Alías, MD
role: Principal Investigator
affiliation: Clínica Corachan, Barcelona
last name: Joaquín Martín, MD
role: Principal Investigator
affiliation: Hospital POLUSA, Lugo
last name: Francisco Moreno, MD
phone: 956292100
phone ext: +34
email: dr.moreno@drlobaton.org
last name: Miguel Casanovas, MD PhD
phone: 916510010
phone ext: +34
email: mcasanovas@inmunotek.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
investigator: 
country: Spain
citation: Piacentini GL, Vicentini L, Mazzi P, Chilosi M, Martinati L, Boner AL. Mite-antigen avoidance can reduce bronchial epithelial shedding in allergic asthmatic children. Clin Exp Allergy. 1998 May;28(5):561-7. doi: 10.1046/j.1365-2222.1998.00260.x.
PMID: 9645592
citation: Yepes-Nunez JJ, Gomez C, Espinoza Y, Cardona R. [The impact of subcutaneous immunotherapy with Dermatophagoides farinae and Dermatophagoides pteronyssinus on the quality of life of patients with allergic rhinitis and asthma]. Biomedica. 2014 Apr-Jun;34(2):282-90. doi: 10.1590/S0120-41572014000200014. Spanish.
PMID: 24967933
citation: Cardona R, Lopez E, Beltran J, Sanchez J. Safety of immunotherapy in patients with rhinitis, asthma or atopic dermatitis using an ultra-rush buildup. A retrospective study. Allergol Immunopathol (Madr). 2014 Mar-Apr;42(2):90-5. doi: 10.1016/j.aller.2012.07.005. Epub 2012 Dec 20.
PMID: 23265265
citation: Bousquet J, Hejjaoui A, Clauzel AM, Guerin B, Dhivert H, Skassa-Brociek W, Michel FB. Specific immunotherapy with a standardized Dermatophagoides pteronyssinus extract. II. Prediction of efficacy of immunotherapy. J Allergy Clin Immunol. 1988 Dec;82(6):971-7. doi: 10.1016/0091-6749(88)90133-9.
PMID: 3204255
citation: Branco Ferreira M, Spinola Santos A, Pereira Santos MC, Palma Carlos ML, Pereira Barbosa MA, Palma Carlos AG. Efficacy and safety of specific immunotherapy with a modified mite extract. Allergol Immunopathol (Madr). 2005 Mar-Apr;33(2):80-5. doi: 10.1157/13072918.
PMID: 15808114
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Asthma
mesh term: Rhinitis, Allergic
mesh term: Conjunctivitis
sharing ipd: No