Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

NCT02409563 | Completed Phase 4

• 2 other identifiers: 2/2013ethics committee approval
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Nasal nitric oxide (nFeNO)

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

  21 days

Study Arms (2)

Budesonide nasal (100 mcg bid)

EXPERIMENTAL

The study will be randomized, controlled parallel group. After 1 week of phase baseline screening (Visit 1), patients will be randomized (1:4) with the assignment of a code (B-200\_da 01 to 08, B-100\_ 01 to 31) (day 0, Visit 2) in 2 groups: N1 (n = 8) = Budesonide nasal spray 100 mcg, 2 v / d; Patients return to control after the 1st week (day 7, Visit 3), after the 2nd week (day 14, Visit 4) and one week after the end of the treatment period (day 21, Visit 5). It will give a tolerance of ± 3 days for the timing of planned visits. In the phase of follow-up, (3 days after the last dose of drug) will be recorded the occurrence of adverse effects (Adverse Event, EA)

Drug: Budesonide nasal spray (100 mcg bid)

Budesonide nasal (50 mcg bid)

EXPERIMENTAL

The study will be randomized, controlled parallel group. After 1 week of phase baseline screening (Visit 1), patients will be randomized (1:4) with the assignment of a code (B-200\_da 01 to 08, B-100\_ 01 to 31) (day 0, Visit 2) in 2 groups: ; N2 (n = 31) = Budesonide nasal spray 50 mcg, 2 v / d. Patients return to control after the 1st week (day 7, Visit 3), after the 2nd week (day 14, Visit 4) and one week after the end of the treatment period (day 21, Visit 5). It will give a tolerance of ± 3 days for the timing of planned visits. In the phase of follow-up, (3 days after the last dose of drug) will be recorded the occurrence of adverse effects (Adverse Event, EA)

Drug: Budesonide nasal spray (50 mcg bid

Interventions

Budesonide nasal spray (100 mcg bid) DRUG

Budesonide nasal (100 mcg bid)

Budesonide nasal spray (50 mcg bid DRUG

Budesonide nasal (50 mcg bid)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead

Study Sites (1)

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

Palermo, Sicily, 90146, Italy

Location

Related Publications (5)

• 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. doi: 10.1016/S1081-1206(10)62798-6.

  PMID: 9723557 RESULT

• 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: 10.1111/j.1399-3038.2007.00613.x.

  PMID: 18399898 RESULT

• 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.

  PMID: 20642206 RESULT

• 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 investigation. Int J Pediatr Otorhinolaryngol. 2006 Mar;70(3):445-52. doi: 10.1016/j.ijporl.2005.07.015. Epub 2005 Sep 2.

  PMID: 16140398 RESULT

• Baraldi E, Azzolin NM, Carra 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. doi: 10.1016/s0954-6111(98)90308-0.

  PMID: 9692122 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: April 7, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

IT (1)