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Status:

COMPLETED

Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age

Lead Sponsor:

Istituto per la Ricerca e l'Innovazione Biomedica

Conditions:

Rhinitis

Rhinitis, Allergic

Eligibility:

All Genders

10-16 years

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • Healthy volunteers (HC)
  • The inclusion criteria for HC are:
  • Negative bronchodilator response;
  • No major nasal septum malformations.
  • The exclusion criteria for HC are:
  • Upper airway infections in the previous 4 weeks;
  • Active smoker;
  • Lifetime history of asthma, rhinitis, or respiratory disease symptoms.
  • Children with non allergic rhinitis (NAR)
  • The inclusion criteria for NAR are:
  • T5SS\>5 in the last 4 weeks.
  • The exclusion criteria for NAR are:
  • At least one positive skin prick test for aeroallergens;
  • Upper airway infections in the previous 4 weeks;
  • Active smoker;
  • Major nasal septum malformations.
  • Rhinitis children, perennial allergy (PAR)
  • The inclusion criteria for PAR are:
  • T5SS\>5 in the last 4 weeks.
  • At least one positive skin prick test for perennial aeroallergens;
  • The exclusion criteria for PAR are:
  • At least one positive skin prick test for seasonal aeroallergens;
  • Upper airway infections in the previous 4 weeks;
  • Active smoker;
  • Major nasal septum malformations.
  • Rhinitis children, seasonal allergy, outside season (OSR)
  • The inclusion criteria for OSR are:
  • T5SS\>5 in the last 4 weeks.
  • At least one positive skin prick test for seasonal aeroallergens;
  • The exclusion criteria for OSR are:
  • At least one positive skin prick test for perennial aeroallergens;
  • Upper airway infections in the previous 4 weeks;
  • Active smoker;
  • Major nasal septum malformations.
  • Rhinitis children, seasonal allergy, within season (OSR)
  • The inclusion criteria for OSR are:
  • T5SS\>5 in the last 4 weeks.
  • At least one positive skin prick test for seasonal aeroallergens;
  • The exclusion criteria for OSR are:
  • At least one positive skin prick test for perennial aeroallergens;
  • Upper airway infections in the previous 4 weeks;
  • Active smoker;
  • Major nasal septum malformations.

Exclusion

    Key Trial Info

    Start Date :

    January 10 2018

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    July 31 2018

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT03286049

    Start Date

    January 10 2018

    End Date

    July 31 2018

    Last Update

    November 16 2018

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

    Palermo, Sicily, Italy, 90146

    Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age | DecenTrialz