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CompletedNCT03286049Rhino-RepUpdated Nov 16, 2018

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

An observational study in Rhinitis, Rhinitis, Allergic and Rhinitis, Allergic, Seasonal, sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Completed at 1 site in Italy. Open to participants aged 10 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-16.

Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
10 Years to 16 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Rhinitis
  • Rhinitis, Allergic
  • Rhinitis, Allergic, Seasonal
  • Rhinitis, Allergic, Perennial
03

Who can participate

Ages eligible
10 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A study population of 40 rhinitis children (10 for each of 4 different rhinitis phenotypes)

attending the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) within the Institute

of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), and a control group of 10 healthy volunteers.

Eligibility criteria

Healthy volunteers (HC)

The inclusion criteria for HC are:

  1. Negative bronchodilator response;
  2. No major nasal septum malformations.

The exclusion criteria for HC are:

  1. Upper airway infections in the previous 4 weeks;
  2. Active smoker;
  3. 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:

  1. At least one positive skin prick test for aeroallergens;
  2. Upper airway infections in the previous 4 weeks;
  3. Active smoker;
  4. Major nasal septum malformations.

Rhinitis children, perennial allergy (PAR)

The inclusion criteria for PAR are:

  1. T5SS>5 in the last 4 weeks.
  2. At least one positive skin prick test for perennial aeroallergens;

The exclusion criteria for PAR are:

  1. At least one positive skin prick test for seasonal aeroallergens;
  2. Upper airway infections in the previous 4 weeks;
  3. Active smoker;
  4. Major nasal septum malformations.

Rhinitis children, seasonal allergy, outside season (OSR)

The inclusion criteria for OSR are:

  1. T5SS>5 in the last 4 weeks.
  2. At least one positive skin prick test for seasonal aeroallergens;

The exclusion criteria for OSR are:

  1. At least one positive skin prick test for perennial aeroallergens;
  2. Upper airway infections in the previous 4 weeks;
  3. Active smoker;
  4. Major nasal septum malformations.

Rhinitis children, seasonal allergy, within season (OSR)

The inclusion criteria for OSR are:

  1. T5SS>5 in the last 4 weeks.
  2. At least one positive skin prick test for seasonal aeroallergens;

The exclusion criteria for OSR are:

  1. At least one positive skin prick test for perennial aeroallergens;
  2. Upper airway infections in the previous 4 weeks;
  3. Active smoker;
  4. Major nasal septum malformations.
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy children (HC)

    10 healthy children

  • Children with non allergic rhinitis (NAR)

    10 children with non allergic rhinitis

  • Rhinitis children, perennial allergy (PAR)

    10 rhinitis children, sensitized to perennial allergens

  • Rhinitis children, seasonal allergy, outside season (OSR)

    10 rhinitis children sensitized to seasonal allergens, observed outside the allergen season

  • Rhinitis children, seasonal allergy, within season (WSR)

    10 rhinitis children sensitized to seasonal allergens, observed during the allergen season

05

What researchers measure

Primary outcomes

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

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

    Time frame: 1 day

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

    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).

    Time frame: 28 days

Secondary outcomes

  1. Correlation between AAR and oral FeNO

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

    Time frame: 28 days

  2. Correlation between AAR and nasal FeNO

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

    Time frame: 28 days

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

    Correlation coefficients between measurements of AAR and total 5 symptom score

    Time frame: 28 days

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

    Correlation coefficients between measurements of FeNO and total 5 symptom score

    Time frame: 28 days

06

Study locations

1 site
  • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
    Palermo, Sicily 90146, Italy
07

References and documents

Publications

  • Cilluffo G, Zicari AM, Ferrante G, Malizia V, Fasola S, Duse M, De Castro G, De Vittori V, Schiavi L, Brindisi G, Petrelli P, La Grutta S. Assessing repeatability and reproducibility of Anterior Active Rhinomanometry (AAR) in children. BMC Med Res Methodol. 2020 Apr 17;20(1):86. doi: 10.1186/s12874-020-00969-1. PubMed 32303189 ↗
08

Registry details

Key details

Study ID
NCT03286049
Lead sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Responsible party
Stefania La Grutta, MD (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., Istituto per la Ricerca e l'Innovazione Biomedica) — Principal investigator
First posted
Sep 18, 2017
Start date
Jan 10, 2018
Primary completion
Jul 31, 2018
Completion
Jul 31, 2018
Last update
Nov 16, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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