Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age
NCT ID: NCT03286049
Last Updated: 2018-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2018-01-10
2018-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Healthy children (HC)
10 healthy children
No interventions assigned to this group
Children with non allergic rhinitis (NAR)
10 children with non allergic rhinitis
No interventions assigned to this group
Rhinitis children, perennial allergy (PAR)
10 rhinitis children, sensitized to perennial allergens
No interventions assigned to this group
Rhinitis children, seasonal allergy, outside season (OSR)
10 rhinitis children sensitized to seasonal allergens, observed outside the allergen season
No interventions assigned to this group
Rhinitis children, seasonal allergy, within season (WSR)
10 rhinitis children sensitized to seasonal allergens, observed during the allergen season
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. No major nasal septum malformations.
1.T5SS\>5 in the last 4 weeks.
1. T5SS\>5 in the last 4 weeks.
2. At least one positive skin prick test for perennial aeroallergens;
1. T5SS\>5 in the last 4 weeks.
2. At least one positive skin prick test for seasonal aeroallergens;
1. T5SS\>5 in the last 4 weeks.
2. At least one positive skin prick test for seasonal aeroallergens;
Exclusion Criteria
2. Active smoker;
3. Lifetime history of asthma, rhinitis, or respiratory disease symptoms.
Children with non allergic rhinitis (NAR)
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)
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)
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)
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.
10 Years
16 Years
ALL
Yes
Sponsors
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Istituto per la Ricerca e l'Innovazione Biomedica
OTHER
Responsible Party
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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.
Locations
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Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, Italy
Countries
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References
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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.
Other Identifiers
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7/2017_C
Identifier Type: -
Identifier Source: org_study_id
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