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NCT Number: NCT03286049

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

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.

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Key information

Conditions

Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Palermo, Sicily, 90146, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

1.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.

Treatment and study plan

Primary outcomes

  1. Short term repeatability of active anterior rhinomanometry (AAR)

    Time frame: 1 day

    For each individual, it will be calculated the coefficient of variation of 5 measurements of AAR taken within 30 minutes, at baseline.

  2. Mid term repeatability of active anterior rhinomanometry (AAR)

    Time frame: 28 days

    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).

Secondary outcomes

  1. Correlation between AAR and oral FeNO

    Time frame: 28 days

    Correlation coefficients between measurements of AAR and oral FeNO (at each visit the mean of 3 consecutive measurements of oral FeNO is considered)

  2. Correlation between AAR and nasal FeNO

    Time frame: 28 days

    Correlation coefficients between measurements of AAR and nasal FeNO (at each visit the mean of 3 consecutive measurements of nasal FeNO is considered)

  3. Correlation between AAR (objective perspective) and T5SS (subjective perspective)

    Time frame: 28 days

    Correlation coefficients between measurements of AAR and total 5 symptom score

  4. Correlation between FeNO (objective perspective) and T5SS (subjective perspective)

    Time frame: 28 days

    Correlation coefficients between measurements of FeNO and total 5 symptom score

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Official study title

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

Acronym: Rhino-Rep

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2017
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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