Clinical trial NCT03286049: Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age
Official title: Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age - Rhino-Rep
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic, Perennial
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Short term repeatability of active anterior rhinomanometry (AAR)
timeFrame: 1 day
measure: Mid term repeatability of active anterior rhinomanometry (AAR)
timeFrame: 28 days
Secondary outcomes:
measure: Correlation between AAR and oral FeNO
timeFrame: 28 days
measure: Correlation between AAR and nasal FeNO
timeFrame: 28 days
measure: Correlation between AAR (objective perspective) and T5SS (subjective perspective)
timeFrame: 28 days
measure: Correlation between FeNO (objective perspective) and T5SS (subjective perspective)
timeFrame: 28 days
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
state: Sicily
Study officials:
References:
citation: 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.