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

Istituto per la Ricerca e l'Innovazione Biomedica

Status: Completed

Conditions: Rhinitis, Allergic, Perennial; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Study type: Observational

Funder types: Other

Identifiers

NCT03286049

7/2017_C

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

50 participants in 5 patient groups

Healthy children (HC)

Description:

10 healthy children

Children with non allergic rhinitis (NAR)

Description:

10 children with non allergic rhinitis

Rhinitis children, perennial allergy (PAR)

Description:

10 rhinitis children, sensitized to perennial allergens

Rhinitis children, seasonal allergy, outside season (OSR)

Description:

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

Rhinitis children, seasonal allergy, within season (WSR)

Description:

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