Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica; Stefania La Grutta, MD
• Treatments: Budesonide

Criteria

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