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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03286049

Acronym

Rhino-Rep

Enrollment

Registered

2017-09-18

Start date

2018-01-10

Completion date

2018-07-31

Last updated

2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Rhinitis, Allergic, Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 16 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results