Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409563
• Other study ID #: 2/2013
• Secondary ID: ethics committee
• Status: Completed
• Phase: Phase 4
• First received: February 7, 2013
• Last updated: January 8, 2018
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: January 2018
• Source: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Budesonide nasal spray (100 mcg bid)

• Budesonide nasal spray (50 mcg bid

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Baraldi E, Azzolin NM, Carrà S, Dario C, Marchesini L, Zacchello F. Effect of topical steroids on nasal nitric oxide production in children with perennial allergic rhinitis: a pilot study. Respir Med. 1998 Mar;92(3):558-61. — View Citation

Bellodi S, Tosca MA, Pulvirenti G, Petecchia L, Serpero L, Silvestri M, Sabatini F, Battistini E, Rossi GA. Activity of budesonide on nasal neutrophilic inflammation and obstruction in children with recurrent upper airway infections. A preliminary investi — View Citation

Meltzer EO, Munafo DA, Chung W, Gopalan G, Varghese ST. Intranasal mometasone furoate therapy for allergic rhinitis symptoms and rhinitis-disturbed sleep. Ann Allergy Asthma Immunol. 2010 Jul;105(1):65-74. doi: 10.1016/j.anai.2010.04.020. — View Citation

Meltzer EO. Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 1998 Aug;81(2):128-34. — View Citation

Pedroletti C, Lundahl J, Alving K, Hedlin G. Effect of nasal steroid treatment on airway inflammation determined by exhaled nitric oxide in allergic schoolchildren with perennial rhinitis and asthma. Pediatr Allergy Immunol. 2008 May;19(3):219-26. doi: 10 — View Citation

Outcome

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

External Links

•   Click here for more information about this study: thematic area, pediatrics