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

NCT03286049 | Completed

• 1 other identifier: 7/2017_C
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Correlation between AAR and oral FeNO

  28 days

• Correlation between AAR and nasal FeNO

  28 days

• Correlation between AAR (objective perspective) and T5SS (subjective perspective)

  28 days

• Correlation between FeNO (objective perspective) and T5SS (subjective perspective)

  28 days

Study Arms (5)

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

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Negative bronchodilator response;
• No major nasal septum malformations.

You may not qualify if:

• Upper airway infections in the previous 4 weeks;
• Active smoker;
• Lifetime history of asthma, rhinitis, or respiratory disease symptoms.
• Children with non allergic rhinitis (NAR)
• T5SS\>5 in the last 4 weeks.
• At least one positive skin prick test for aeroallergens;
• Upper airway infections in the previous 4 weeks;
• Active smoker;
• Major nasal septum malformations.
• Rhinitis children, perennial allergy (PAR)
• T5SS\>5 in the last 4 weeks.
• At least one positive skin prick test for perennial aeroallergens;
• At least one positive skin prick test for seasonal aeroallergens;
• Upper airway infections in the previous 4 weeks;
• Active smoker;

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead

Study Sites (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, 90146, Italy

Location

Related Publications (1)

• 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.

  PMID: 32303189 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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.

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 18, 2017
• Study Start: January 10, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

IT (1)