Clinical Trials Directory

Trials / Completed

CompletedNCT02409563

Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

Effectiveness of Nasal Budesonide on Control of Airway Inflammation by Determining FeNO in Children With Allergic Rhinitis.

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
39 (actual)
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica · Academic / Other
Sex
All
Age
6 Years – 14 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGBudesonide nasal spray (100 mcg bid)
DRUGBudesonide nasal spray (50 mcg bid

Timeline

Start date
2014-01-01
Primary completion
2014-03-01
Completion
2014-03-01
First posted
2015-04-07
Last updated
2018-01-09

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT02409563. Inclusion in this directory is not an endorsement.