drugset / Trial / NCT02409563

Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

NCT02409563

RandomizedParallel-groupSingle-blindTreatment

Summary

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).

Timeline

Start
2014-01
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 50 ug Intranasal
Subject Budesonide Small molecule 100 ug Intranasal

Indications