Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

Stefania La Grutta, MD68 enrolled

Overview

The purpose of this study is to examine in children with persistent AR the effect of the topically applied beclomethasone in comparison with cetirizine on nasal patency evaluated by acoustic rhinometry and subjective nasal symptoms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

Nasal Beclomethasone DipropionateDRUG

Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days.

CERCHIO 10 mg/ml OSDRUG

For Children \< 12 years old 10 drops die (5 mg die) for 21 days. For Children \> 12 years old 20 drops die (10 mg die) for 21 days.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * children 6-16 years of age with a history of AR in the previous year * T5SS: ≥5 in the last week before enrollment Exclusion Criteria: * asthma symptoms * acute upper respiratory infections * anatomic nasal defects (ie, septum deviation), or nasal polyps * use in the past 4 weeks of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines.

Locations (2)

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

Palermo, Sicily, Italy

Institute of Biomedicine and Molecular Immunology, IBIM

Palermo, Italy

Outcomes

Primary Outcomes

Nasal patency evaluated by acoustic rhinometry.

The main objective is to assess the increase of nasal patency in children aged 6-16 with perennial allergic rhinitis (PAR), treated with Beclometasone nasal spray 100 µg/die for 21 days.

Time frame: 21 days

Secondary Outcomes

Efficacy of Beclometasone nasal spray on subjective nasal symptoms

The secondary objective is to measure the impact of Beclometasone nasal spray 100 µg on subjective nasal symptoms, in children aged 6-16 with perennial allergic rhinitis (PAR), assessed by T4SS Questionnaire(Total 4 Symptoms Score).

Time frame: 21 days

Data from ClinicalTrials.gov

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