Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

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).

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, 90146, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide nasal spray (100 mcg bid)

Drug

Budesonide nasal spray (50 mcg bid

Drug

Primary outcomes

Nasal nitric oxide (nFeNO)

Time frame: 21 days

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

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Apr 7, 2015
Registry last updated: Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed