Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

Istituto per la Ricerca e l'Innovazione Biomedica39 enrolled

Overview

In clinical trials for treatment of allergic rhinitis a significant reduction of the total symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous results in adults show that the assessment and monitoring del nasal fractional exhaled nitric oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis. Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous solution) on the nasal inflammation marker (nFeNO). Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total Symptom Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported sleep quality (Pittsburgh Sleep Quality Index, PSQI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * history of allergic rhinitis for at least 1 year * children aged 6 - 14 years * Total Symptom Score (T5SS) more than 6 in the last 4 days before the screening visit Exclusion Criteria: * signs of acute respiratory infection * systemic immunological and metabolic disease * major malformations of the upper airways * topical or systemic therapy with antibiotics, antihistamines and corticosteroids in the 30 days prior to the study * patient active smoker

Outcomes

Primary Outcomes

Nasal nitric oxide (nFeNO)

Assessment of the influence of nasal Budesonide (aqueous solution) on nasal FeNo (nFeNO) in children with allergic rhinitis.

Time frame: 21 days