<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/NCT03286049</url>
  </required_header>
  <id_info>
    <org_study_id>7/2017_C</org_study_id>
    <nct_id>NCT03286049</nct_id>
  </id_info>
  <brief_title>Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age</brief_title>
  <acronym>Rhino-Rep</acronym>
  <official_title>Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age - Rhino-Rep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto per la Ricerca e l'Innovazione Biomedica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto per la Ricerca e l'Innovazione Biomedica</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>
      Longitudinal, observational study to assess the short-term (test re-test) and mid-term&#xD;
      (within the span of 28 days) repeatability of active anterior rhinomanometry (AAR) measures&#xD;
      on 4 parallel groups of children with different rhinitis phenotypes, and 1 group of control&#xD;
      (healthy) children.&#xD;
&#xD;
      Secondary objectives are: i) assessing of association between AAR, exhaled FeNO (eFeNO) and&#xD;
      nasal FeNO (nFeNO); ii) assessing association between objective measurements (AAR, eFeNO and&#xD;
      nFeNO) and subjective measurements (Total 5 Symptom score, T5SS).&#xD;
&#xD;
      The study is intended to obtain useful information for improving rhinitis management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Short term repeatability of active anterior rhinomanometry (AAR)</measure>
    <time_frame>1 day</time_frame>
    <description>For each individual, it will be calculated the coefficient of variation of 5 measurements of AAR taken within 30 minutes, at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mid term repeatability of active anterior rhinomanometry (AAR)</measure>
    <time_frame>28 days</time_frame>
    <description>For each individual, it will be calculated the coefficient of variation of 3 measurements of AAR taken at baseline and then twice more within the span of 28 days (after one week and after two weeks).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between AAR and oral FeNO</measure>
    <time_frame>28 days</time_frame>
    <description>Correlation coefficients between measurements of AAR and oral FeNO (at each visit the mean of 3 consecutive measurements of oral FeNO is considered)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between AAR and nasal FeNO</measure>
    <time_frame>28 days</time_frame>
    <description>Correlation coefficients between measurements of AAR and nasal FeNO (at each visit the mean of 3 consecutive measurements of nasal FeNO is considered)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between AAR (objective perspective) and T5SS (subjective perspective)</measure>
    <time_frame>28 days</time_frame>
    <description>Correlation coefficients between measurements of AAR and total 5 symptom score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between FeNO (objective perspective) and T5SS (subjective perspective)</measure>
    <time_frame>28 days</time_frame>
    <description>Correlation coefficients between measurements of FeNO and total 5 symptom score</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Rhinitis</condition>
  <condition>Rhinitis, Allergic</condition>
  <condition>Rhinitis, Allergic, Seasonal</condition>
  <condition>Rhinitis, Allergic, Perennial</condition>
  <arm_group>
    <arm_group_label>Healthy children (HC)</arm_group_label>
    <description>10 healthy children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children with non allergic rhinitis (NAR)</arm_group_label>
    <description>10 children with non allergic rhinitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rhinitis children, perennial allergy (PAR)</arm_group_label>
    <description>10 rhinitis children, sensitized to perennial allergens</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rhinitis children, seasonal allergy, outside season (OSR)</arm_group_label>
    <description>10 rhinitis children sensitized to seasonal allergens, observed outside the allergen season</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rhinitis children, seasonal allergy, within season (WSR)</arm_group_label>
    <description>10 rhinitis children sensitized to seasonal allergens, observed during the allergen season</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A study population of 40 rhinitis children (10 for each of 4 different rhinitis phenotypes)&#xD;
&#xD;
        attending the outpatient clinic of Pediatric Allergology &amp; Pulmonology (PAP) within the&#xD;
        Institute&#xD;
&#xD;
        of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of&#xD;
        Palermo (IBIM CNR), and a control group of 10 healthy volunteers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Healthy volunteers (HC)&#xD;
&#xD;
        The inclusion criteria for HC are:&#xD;
&#xD;
          1. Negative bronchodilator response;&#xD;
&#xD;
          2. No major nasal septum malformations.&#xD;
&#xD;
        The exclusion criteria for HC are:&#xD;
&#xD;
          1. Upper airway infections in the previous 4 weeks;&#xD;
&#xD;
          2. Active smoker;&#xD;
&#xD;
          3. Lifetime history of asthma, rhinitis, or respiratory disease symptoms.&#xD;
&#xD;
        Children with non allergic rhinitis (NAR)&#xD;
&#xD;
        The inclusion criteria for NAR are:&#xD;
&#xD;
        1.T5SS&gt;5 in the last 4 weeks.&#xD;
&#xD;
        The exclusion criteria for NAR are:&#xD;
&#xD;
          1. At least one positive skin prick test for aeroallergens;&#xD;
&#xD;
          2. Upper airway infections in the previous 4 weeks;&#xD;
&#xD;
          3. Active smoker;&#xD;
&#xD;
          4. Major nasal septum malformations.&#xD;
&#xD;
        Rhinitis children, perennial allergy (PAR)&#xD;
&#xD;
        The inclusion criteria for PAR are:&#xD;
&#xD;
          1. T5SS&gt;5 in the last 4 weeks.&#xD;
&#xD;
          2. At least one positive skin prick test for perennial aeroallergens;&#xD;
&#xD;
        The exclusion criteria for PAR are:&#xD;
&#xD;
          1. At least one positive skin prick test for seasonal aeroallergens;&#xD;
&#xD;
          2. Upper airway infections in the previous 4 weeks;&#xD;
&#xD;
          3. Active smoker;&#xD;
&#xD;
          4. Major nasal septum malformations.&#xD;
&#xD;
        Rhinitis children, seasonal allergy, outside season (OSR)&#xD;
&#xD;
        The inclusion criteria for OSR are:&#xD;
&#xD;
          1. T5SS&gt;5 in the last 4 weeks.&#xD;
&#xD;
          2. At least one positive skin prick test for seasonal aeroallergens;&#xD;
&#xD;
        The exclusion criteria for OSR are:&#xD;
&#xD;
          1. At least one positive skin prick test for perennial aeroallergens;&#xD;
&#xD;
          2. Upper airway infections in the previous 4 weeks;&#xD;
&#xD;
          3. Active smoker;&#xD;
&#xD;
          4. Major nasal septum malformations.&#xD;
&#xD;
        Rhinitis children, seasonal allergy, within season (OSR)&#xD;
&#xD;
        The inclusion criteria for OSR are:&#xD;
&#xD;
          1. T5SS&gt;5 in the last 4 weeks.&#xD;
&#xD;
          2. At least one positive skin prick test for seasonal aeroallergens;&#xD;
&#xD;
        The exclusion criteria for OSR are:&#xD;
&#xD;
          1. At least one positive skin prick test for perennial aeroallergens;&#xD;
&#xD;
          2. Upper airway infections in the previous 4 weeks;&#xD;
&#xD;
          3. Active smoker;&#xD;
&#xD;
          4. Major nasal septum malformations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council</name>
      <address>
        <city>Palermo</city>
        <state>Sicily</state>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto per la Ricerca e l'Innovazione Biomedica</investigator_affiliation>
    <investigator_full_name>Stefania La Grutta, MD</investigator_full_name>
    <investigator_title>Ph.D. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
    <mesh_term>Rhinitis, Allergic, Perennial</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/NCT03286049
org study id: 7/2017_C
nct id: NCT03286049
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Longitudinal, observational study to assess the short-term (test re-test) and mid-term
      (within the span of 28 days) repeatability of active anterior rhinomanometry (AAR) measures
      on 4 parallel groups of children with different rhinitis phenotypes, and 1 group of control
      (healthy) children.

      Secondary objectives are: i) assessing of association between AAR, exhaled FeNO (eFeNO) and
      nasal FeNO (nFeNO); ii) assessing association between objective measurements (AAR, eFeNO and
      nFeNO) and subjective measurements (Total 5 Symptom score, T5SS).

      The study is intended to obtain useful information for improving rhinitis management.
observational model: Other
time perspective: Prospective
measure: Short term repeatability of active anterior rhinomanometry (AAR)
time frame: 1 day
description: For each individual, it will be calculated the coefficient of variation of 5 measurements of AAR taken within 30 minutes, at baseline.
measure: Mid term repeatability of active anterior rhinomanometry (AAR)
time frame: 28 days
description: For each individual, it will be calculated the coefficient of variation of 3 measurements of AAR taken at baseline and then twice more within the span of 28 days (after one week and after two weeks).
measure: Correlation between AAR and oral FeNO
time frame: 28 days
description: Correlation coefficients between measurements of AAR and oral FeNO (at each visit the mean of 3 consecutive measurements of oral FeNO is considered)
measure: Correlation between AAR and nasal FeNO
time frame: 28 days
description: Correlation coefficients between measurements of AAR and nasal FeNO (at each visit the mean of 3 consecutive measurements of nasal FeNO is considered)
measure: Correlation between AAR (objective perspective) and T5SS (subjective perspective)
time frame: 28 days
description: Correlation coefficients between measurements of AAR and total 5 symptom score
measure: Correlation between FeNO (objective perspective) and T5SS (subjective perspective)
time frame: 28 days
description: Correlation coefficients between measurements of FeNO and total 5 symptom score
arm group label: Healthy children (HC)
description: 10 healthy children
arm group label: Children with non allergic rhinitis (NAR)
description: 10 children with non allergic rhinitis
arm group label: Rhinitis children, perennial allergy (PAR)
description: 10 rhinitis children, sensitized to perennial allergens
arm group label: Rhinitis children, seasonal allergy, outside season (OSR)
description: 10 rhinitis children sensitized to seasonal allergens, observed outside the allergen season
arm group label: Rhinitis children, seasonal allergy, within season (WSR)
description: 10 rhinitis children sensitized to seasonal allergens, observed during the allergen season
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
investigator full name: Stefania La Grutta, MD
investigator title: Ph.D. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal
mesh term: Rhinitis, Allergic, Perennial