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

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

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day
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).	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	28 days
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)	28 days
Correlation between AAR (objective perspective) and T5SS (subjective perspective)	Correlation coefficients between measurements of AAR and total 5 symptom score	28 days
Correlation between FeNO (objective perspective) and T5SS (subjective perspective)	Correlation coefficients between measurements of FeNO and total 5 symptom score	28 days

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: 7/2017_C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No