<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/NCT03276416</url>
  </required_header>
  <id_info>
    <org_study_id>7/2017_A</org_study_id>
    <nct_id>NCT03276416</nct_id>
  </id_info>
  <brief_title>RAPP-children, Rhinitis &amp; Asthma in Patient Perspective: Development and Validation of a Questionnaire for Quality of Life Evaluation in Children With Asthma and Allergic Rhinitis</brief_title>
  <acronym>RAPP</acronym>
  <official_title>RAPP-children, Rhinitis &amp; Asthma in Patient Perspective: Development and Validation of a Questionnaire for Quality of Life Evaluation in Children With Asthma and Allergic Rhinitis</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>
      This observational study aims at developing and validating a simple questionnaire to be&#xD;
      routinely applied in the clinical practice, for the evaluation of the quality of life in&#xD;
      children with concomitant asthma and allergic rhinitis. The study consists of two phases:&#xD;
&#xD;
      Phase 1: Development of the RAPP-children questionnaire starting from the validated&#xD;
      RHINASTHMA-children questionnaire.&#xD;
&#xD;
      Phase 2: Administration and validation of the RAPP-children questionnaire. 150 children with&#xD;
      concomitant asthma and allergic rhinitis will be followed-up for one month. Both at baseline&#xD;
      and after one month, the RAPP children and several other standardized questionnaires will be&#xD;
      administered.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>RAPP-children response patterns</measure>
    <time_frame>1 months</time_frame>
    <description>Multivariate analyses of the responses to the RAPP-children questions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>RHINASTHMA-children response patterns</measure>
    <time_frame>1 months</time_frame>
    <description>Frequency distributions of the responses to the RHINASTHMA-children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-ACT response patterns</measure>
    <time_frame>1 months</time_frame>
    <description>Frequency distributions of the responses to the C-ACT (Childhood Asthma Control Test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS response pattern</measure>
    <time_frame>1 months</time_frame>
    <description>Frequency distribution of the response to the VAS (Visual Analog Scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kiddy-KINDL response patterns</measure>
    <time_frame>1 months</time_frame>
    <description>Frequency distributions of the response to the Kiddy-KINDL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function: FEV1</measure>
    <time_frame>1 months</time_frame>
    <description>Forced expiratory volume in the first second</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function: FVC</measure>
    <time_frame>1 months</time_frame>
    <description>Forced vital capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function: FEF25-75</measure>
    <time_frame>1 months</time_frame>
    <description>Forced expiratory flow at 25-75%</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Asthma</condition>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>150 children with concomitant asthma and rhinitis</arm_group_label>
    <description>Baseline and one-month administration of RAPP-children, RHINASTHMA-children, C-ACT, VAS, Kiddy KINDLE, GRS. Baseline and one-month spirometry.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A study population of 150 children with concomitant asthma and allergic rhinitis, aged 6 to&#xD;
        11 years, both males and females, followed-up for one month at the outpatient clinic of&#xD;
        Pediatric Allergology &amp; Pulmonology (PAP) within the Institute of Biomedicine and Molecular&#xD;
        Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 6 and 11 years&#xD;
&#xD;
          -  Concomitant asthma and allergic rhinitis&#xD;
&#xD;
          -  Males and Females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunological and metabolic systemic disease&#xD;
&#xD;
          -  Major malformations of the upper airways&#xD;
&#xD;
          -  Active smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</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>September 2019</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</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>MD. 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>Asthma</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/NCT03276416
org study id: 7/2017_A
nct id: NCT03276416
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study aims at developing and validating a simple questionnaire to be
      routinely applied in the clinical practice, for the evaluation of the quality of life in
      children with concomitant asthma and allergic rhinitis. The study consists of two phases:

      Phase 1: Development of the RAPP-children questionnaire starting from the validated
      RHINASTHMA-children questionnaire.

      Phase 2: Administration and validation of the RAPP-children questionnaire. 150 children with
      concomitant asthma and allergic rhinitis will be followed-up for one month. Both at baseline
      and after one month, the RAPP children and several other standardized questionnaires will be
      administered.
observational model: Other
time perspective: Prospective
measure: RAPP-children response patterns
time frame: 1 months
description: Multivariate analyses of the responses to the RAPP-children questions
measure: RHINASTHMA-children response patterns
time frame: 1 months
description: Frequency distributions of the responses to the RHINASTHMA-children
measure: C-ACT response patterns
time frame: 1 months
description: Frequency distributions of the responses to the C-ACT (Childhood Asthma Control Test)
measure: VAS response pattern
time frame: 1 months
description: Frequency distribution of the response to the VAS (Visual Analog Scale)
measure: Kiddy-KINDL response patterns
time frame: 1 months
description: Frequency distributions of the response to the Kiddy-KINDL
measure: Pulmonary function: FEV1
time frame: 1 months
description: Forced expiratory volume in the first second
measure: Pulmonary function: FVC
time frame: 1 months
description: Forced vital capacity
measure: Pulmonary function: FEF25-75
time frame: 1 months
description: Forced expiratory flow at 25-75%
arm group label: 150 children with concomitant asthma and rhinitis
description: Baseline and one-month administration of RAPP-children, RHINASTHMA-children, C-ACT, VAS, Kiddy KINDLE, GRS. Baseline and one-month spirometry.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
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: MD. 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: Asthma
mesh term: Rhinitis, Allergic