Rhinitis Clinical Trial
— Rhino-RepOfficial title:
Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age - Rhino-Rep
NCT number | NCT03286049 |
Other study ID # | 7/2017_C |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 10, 2018 |
Est. completion date | July 31, 2018 |
Verified date | November 2018 |
Source | Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 16 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council | Palermo | Sicily |
Lead Sponsor | Collaborator |
---|---|
Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Correlation between AAR and nasal FeNO | 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 | |
Secondary | Correlation between AAR (objective perspective) and T5SS (subjective perspective) | Correlation coefficients between measurements of AAR and total 5 symptom score | 28 days | |
Secondary | Correlation between FeNO (objective perspective) and T5SS (subjective perspective) | Correlation coefficients between measurements of FeNO and total 5 symptom score | 28 days |
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