<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/NCT02233426</url>
  </required_header>
  <id_info>
    <org_study_id>NKU-001</org_study_id>
    <nct_id>NCT02233426</nct_id>
  </id_info>
  <brief_title>Effect of Hypertonic Solutions on Allergic Rhinitis Patients</brief_title>
  <acronym>hypertonic</acronym>
  <official_title>Do Hypertonic Solutions Have an Impact on Nasal Eosinophilia in Allergic Rhinitis Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Namik Kemal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Namik Kemal University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectivity of using hypertonic nasal solutions&#xD;
      alone on the symptom scores and nasal eosinophil levels of allergic rhinitis patients,&#xD;
      retrospectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The medical records of the patients who admitted to outpatient clinic of otorhinolaryngology&#xD;
      department of a tertiary referral center were retrospectively investigated. The symptom&#xD;
      scores and nasal eosinophil levels of the patients were recorded. Patients using hypertonic&#xD;
      solutions alone or steroid nasal spray alone were compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The number of eosinophils in nasal secretions</measure>
    <time_frame>The number of eosinophils in nasal secretions that was counted before the therapy and after the first month of therapy would be recorded</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sinonasal Outcome Test (SNOT-22) questionairre scores</measure>
    <time_frame>SNOT-22 scores obtained before the treatment and after the first month of treatment would be recorded</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Allergic Rhinitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Medical records of patients who admitted to the outpatient clinic of a tertiary referral&#xD;
        center was enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with positive Prick's test to at least one allergen and diagnosed as having&#xD;
             allergic rhinitis were included&#xD;
&#xD;
          -  Patients who used hypertonic nasal solution alone for at least one month were included&#xD;
             as sthe study group&#xD;
&#xD;
          -  Patients who used nasal steroid spray alone or at least one month were included as&#xD;
             sthe study group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of asthma, urticeria, eczama, diabetes mellitus, hypertension,&#xD;
             COPD and other systemic diseases were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zafer Ciftci, Assist. Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Namik Kemal University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zafer Ciftci, Assist. Prof</last_name>
    <phone>00905325540605</phone>
    <email>zaferciftci@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Namik Kemal University, Department of Otorhinolaryngology</name>
      <address>
        <city>Tekirdag</city>
        <zip>59100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <contact>
      <last_name>Zafer Ciftci, Assist. Prof</last_name>
    </contact>
    <investigator>
      <last_name>Zafer Ciftci, Assist. Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 3, 2014</last_update_submitted>
  <last_update_submitted_qc>September 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Namik Kemal University</investigator_affiliation>
    <investigator_full_name>Zafer Ciftci</investigator_full_name>
    <investigator_title>Assist. Prof., M.D.</investigator_title>
  </responsible_party>
  <keyword>allergic rhinitis</keyword>
  <keyword>nasal steroid</keyword>
  <keyword>hypertonic saline</keyword>
  <keyword>eosinophil</keyword>
  <keyword>symptom score</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/NCT02233426
org study id: NKU-001
nct id: NCT02233426
lead sponsor: 
has dmc: No
The purpose of this study is to assess the effectivity of using hypertonic nasal solutions
      alone on the symptom scores and nasal eosinophil levels of allergic rhinitis patients,
      retrospectively.
The medical records of the patients who admitted to outpatient clinic of otorhinolaryngology
      department of a tertiary referral center were retrospectively investigated. The symptom
      scores and nasal eosinophil levels of the patients were recorded. Patients using hypertonic
      solutions alone or steroid nasal spray alone were compared.
observational model: Case-Control
time perspective: Retrospective
measure: The number of eosinophils in nasal secretions
time frame: The number of eosinophils in nasal secretions that was counted before the therapy and after the first month of therapy would be recorded
measure: Sinonasal Outcome Test (SNOT-22) questionairre scores
time frame: SNOT-22 scores obtained before the treatment and after the first month of treatment would be recorded
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Zafer Ciftci, Assist. Prof
role: Principal Investigator
affiliation: Namik Kemal University
last name: Zafer Ciftci, Assist. Prof
phone: 00905325540605
email: zaferciftci@yahoo.com
facility: 
contact: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Namik Kemal University
investigator full name: Zafer Ciftci
investigator title: Assist. Prof., M.D.
mesh term: Rhinitis
mesh term: Rhinitis, Allergic