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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02409563

Enrollment

Registered

2015-04-07

Start date

2014-01-31

Completion date

2014-03-31

Last updated

2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Brief 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).

Interventions

DRUGBudesonide nasal spray (100 mcg bid)

DRUGBudesonide nasal spray (50 mcg bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Nasal nitric oxide (nFeNO)	21 days	Assessment of the influence of nasal Budesonide (aqueous solution) on nasal FeNo (nFeNO) in children with allergic rhinitis.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026