<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/NCT02214303</url>
  </required_header>
  <id_info>
    <org_study_id>SAIRA-1017/2012</org_study_id>
    <nct_id>NCT02214303</nct_id>
  </id_info>
  <brief_title>The Role of Th9 Cells and Eosinophils Activity in Allergic Airway Diseases</brief_title>
  <acronym>SAIRA</acronym>
  <official_title>The Role of Th9 Cells Expression and Eosinophils Activity in the Course of Allergic Airway Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lithuanian University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lithuanian University of Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of allergic diseases, especially airway allergic diseases, has increased&#xD;
      dramatically over the last twenty years all over the world including Lithuania. Allergic&#xD;
      diseases are associated with significantly reduced quality of life and can sometimes cause&#xD;
      death. Allergic diseases have turned into an important economic and social burden and&#xD;
      nowadays take a more and more important place in the health system. Despite all intensive&#xD;
      investigations, the pathogenesis of allergic airway diseases still remains unclear. As&#xD;
      allergic diseases have a systemic pattern and multicomponent pathogenesis, it is important to&#xD;
      investigate not individual cells, but examine various inflammatory cells instead, including&#xD;
      their biological products and possible cellular interactions along the course of allergic&#xD;
      diseases. This research focuses on the cells that are claimed to be important in the&#xD;
      pathogenesis of allergic airway diseases, i.e. a newly found effector T helper cell subset&#xD;
      (Th9 cells), which still lacks deeper investigation, and the main inflammatory cell,&#xD;
      eosinophil. This study aims at determining the importance the way the Th9 lymphocytes&#xD;
      perform, the eosinophil's activity, as well as molecular factors affecting these cells has in&#xD;
      the process of prognostication of allergic airway diseases, namely allergic rhinitis and&#xD;
      allergic asthma. An allergen challenge test will be performed in order to define the meaning&#xD;
      of pathogenetic changes. The results of this research may reveal useful information in the&#xD;
      course of allergic diseases and may be valuable when creating strategic principles of&#xD;
      prophylaxis. The findings could be used for prevention and early diagnostics of allergic&#xD;
      diseases and it could also open doors to discovering new and effective treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Th9 cells and eosinophil apoptosis</measure>
    <time_frame>24 hours after bronchial allergen challenge</time_frame>
    <description>Blood and sputum eosinophils also peripheral blood th9 cells will be investigated.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Allergic Asthma</condition>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Allergic asthma</arm_group_label>
    <description>Allergic asthma (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Allergic rhinitis</arm_group_label>
    <description>allergic rhinitis patients (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Healthy subjects</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Induced sputum and peripheral blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Allergic asthma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        I. Inclusion criteria:&#xD;
&#xD;
          1. Men and women between the ages of 18-50 years;&#xD;
&#xD;
          2. Allergic asthma (skin prick test positive for D. pteronyssinus, 5 grass mixture or&#xD;
             birch pollen);&#xD;
&#xD;
          3. Symptoms more than one year;&#xD;
&#xD;
          4. Positive Bronchial challenge with methacholine or documented completely reversible&#xD;
             bronchial obstruction;&#xD;
&#xD;
          5. Stable lung function (FEV1≥70 perc.);&#xD;
&#xD;
          6. Allergic rhinitis diagnosed according ARIA criteria.&#xD;
&#xD;
          7. Postmenopausal women. Premenopausal women if pregnancy test is negative&#xD;
&#xD;
          8. Healthy (subjects who are not sick with acute or chronic inflammatory, infectious,&#xD;
             oncologic or immune diseases) - control group&#xD;
&#xD;
          9. Participants who gave his/her informed written consent.&#xD;
&#xD;
        II. Exclusion criteria&#xD;
&#xD;
          1. Asthma and rhinitis exacerbation;&#xD;
&#xD;
          2. Clinically significant permanent allergy symptoms (ex. cat or dog dander induced&#xD;
             allergy);&#xD;
&#xD;
          3. Active airway infection 1 month prior the study;&#xD;
&#xD;
          4. Used medicaments:&#xD;
&#xD;
               1. Inhaled glucocorticoids intake 1 month prior the study;&#xD;
&#xD;
               2. Antihistamines intake 7 days prior the study;&#xD;
&#xD;
               3. Short acting β2 agonists 12 hours prior the study;&#xD;
&#xD;
               4. Long acting β2 agonists 2 days prior the study;&#xD;
&#xD;
               5. Leukotriene receptor antagonists prior 14 days;&#xD;
&#xD;
          5. If the histamine mean wheal diameter is &lt;= 3 mm or control mean wheal diameter is &gt;= 3&#xD;
             mm;&#xD;
&#xD;
          6. Psychiatric disorders;&#xD;
&#xD;
          7. Alcohol or narcotic abuse;&#xD;
&#xD;
          8. Pregnancy.&#xD;
&#xD;
          9. Breast-feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raimundas Sakalauskas, Prof., dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Lithuanian University of Health Sciences, Pulmonology and Immunology department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raimundas Sakalauskas, prof., dr.</last_name>
    <phone>376953</phone>
    <phone_ext>+370</phone_ext>
    <email>raimundas.sakalauskas@kaunoklinikos.lt</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Deimante Hoppenot, MD</last_name>
    <phone>67439677</phone>
    <phone_ext>+370</phone_ext>
    <email>deimante@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Lithuanian University of Health Sciences</name>
      <address>
        <city>Kaunas</city>
        <zip>50009</zip>
        <country>Lithuania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raimundas Sakalauskas, prof., dr.</last_name>
      <phone>37326953</phone>
      <phone_ext>+370</phone_ext>
      <email>raimundas.sakalauskas@kaunoklinikos.lt</email>
    </contact>
    <contact_backup>
      <last_name>Deimante Hoppenot, MD</last_name>
      <phone>67439677</phone>
      <phone_ext>+370</phone_ext>
      <email>deimante@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Lithuania</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 10, 2014</last_update_submitted>
  <last_update_submitted_qc>August 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lithuanian University of Health Sciences</investigator_affiliation>
    <investigator_full_name>Raimundas Sakalauskas</investigator_full_name>
    <investigator_title>prof., dr.</investigator_title>
  </responsible_party>
  <keyword>Allergic asthma</keyword>
  <keyword>Allergic rhinitis</keyword>
  <keyword>Healthy subjects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02214303
org study id: SAIRA-1017/2012
nct id: NCT02214303
lead sponsor: 
has dmc: Yes
The prevalence of allergic diseases, especially airway allergic diseases, has increased
      dramatically over the last twenty years all over the world including Lithuania. Allergic
      diseases are associated with significantly reduced quality of life and can sometimes cause
      death. Allergic diseases have turned into an important economic and social burden and
      nowadays take a more and more important place in the health system. Despite all intensive
      investigations, the pathogenesis of allergic airway diseases still remains unclear. As
      allergic diseases have a systemic pattern and multicomponent pathogenesis, it is important to
      investigate not individual cells, but examine various inflammatory cells instead, including
      their biological products and possible cellular interactions along the course of allergic
      diseases. This research focuses on the cells that are claimed to be important in the
      pathogenesis of allergic airway diseases, i.e. a newly found effector T helper cell subset
      (Th9 cells), which still lacks deeper investigation, and the main inflammatory cell,
      eosinophil. This study aims at determining the importance the way the Th9 lymphocytes
      perform, the eosinophil's activity, as well as molecular factors affecting these cells has in
      the process of prognostication of allergic airway diseases, namely allergic rhinitis and
      allergic asthma. An allergen challenge test will be performed in order to define the meaning
      of pathogenetic changes. The results of this research may reveal useful information in the
      course of allergic diseases and may be valuable when creating strategic principles of
      prophylaxis. The findings could be used for prevention and early diagnostics of allergic
      diseases and it could also open doors to discovering new and effective treatment.
time perspective: Prospective
measure: Th9 cells and eosinophil apoptosis
time frame: 24 hours after bronchial allergen challenge
description: Blood and sputum eosinophils also peripheral blood th9 cells will be investigated.
arm group label: Allergic asthma
description: Allergic asthma (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens)
arm group label: Allergic rhinitis
description: allergic rhinitis patients (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens)
arm group label: Control group
description: Healthy subjects
Induced sputum and peripheral blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raimundas Sakalauskas, Prof., dr.
role: Study Chair
affiliation: Lithuanian University of Health Sciences, Pulmonology and Immunology department
last name: Raimundas Sakalauskas, prof., dr.
phone: 376953
phone ext: +370
email: raimundas.sakalauskas@kaunoklinikos.lt
last name: Deimante Hoppenot, MD
phone: 67439677
phone ext: +370
email: deimante@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Lithuania
responsible party type: Principal Investigator
investigator affiliation: Lithuanian University of Health Sciences
investigator full name: Raimundas Sakalauskas
investigator title: prof., dr.
mesh term: Rhinitis
mesh term: Rhinitis, Allergic