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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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 |
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Healthy volunteers (HC)
The inclusion criteria for HC are:
The exclusion criteria for HC are:
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:
Rhinitis children, perennial allergy (PAR)
The inclusion criteria for PAR are:
The exclusion criteria for PAR are:
Rhinitis children, seasonal allergy, outside season (OSR)
The inclusion criteria for OSR are:
The exclusion criteria for OSR are:
Rhinitis children, seasonal allergy, within season (OSR)
The inclusion criteria for OSR are:
The exclusion criteria for OSR are:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council | Palermo | Sicily | 90146 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32303189 | Derived | 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. |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D065631 | Rhinitis, Allergic |
| D006255 | Rhinitis, Allergic, Seasonal |
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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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 |
| D010038 |
| Otorhinolaryngologic Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |