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

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica (Other)

Overall Status

Completed

CT.gov ID

NCT03286049

Collaborator

(none)

Enrollment

Location

6.6

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 10, 2018

Actual Primary Completion Date :

Jul 31, 2018

Actual Study Completion Date :

Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Short term repeatability of active anterior rhinomanometry (AAR) [1 day]
For each individual, it will be calculated the coefficient of variation of 5 measurements of AAR taken within 30 minutes, at baseline.
Mid term repeatability of active anterior rhinomanometry (AAR) [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 Outcome Measures

Correlation between AAR and oral FeNO [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)
Correlation between AAR and nasal FeNO [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)
Correlation between AAR (objective perspective) and T5SS (subjective perspective) [28 days]
Correlation coefficients between measurements of AAR and total 5 symptom score
Correlation between FeNO (objective perspective) and T5SS (subjective perspective) [28 days]
Correlation coefficients between measurements of FeNO and total 5 symptom score

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily	Italy	90146

Sponsors and Collaborators

Istituto per la Ricerca e l'Innovazione Biomedica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

ClinicalTrials.gov Identifier:

NCT03286049

Other Study ID Numbers: