CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 39 enrolled
Drug / intervention
Budesonide nasal spray (100 mcg bid) +1 moredrug
Likely dose
Budesonide nasal spray (100 mcg bid)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02409563
NCT02409563Phase 4Completed

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

Istituto per la Ricerca e l'Innovazione Biomedica·interventional·Posted Apr 7, 2015·Updated Jan 9, 2018

In Brief

A Phase 4 clinical trial evaluating Budesonide nasal spray (100 mcg bid) and Budesonide nasal spray (50 mcg bid for Allergic Rhinitis. Completed, enrolled 39 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 7, 2015
Enrollment StartJan 1, 2014
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.2 years ago

Interventions

Budesonide nasal spray (100 mcg bid)drug

Budesonide nasal spray (50 mcg biddrug