Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

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.

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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–16 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, Italy

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Nasal Beclomethasone Dipropionate

Drug

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

Other names: NBDP

CERCHIO 10 mg/ml OS

Drug

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.

Primary outcomes

Nasal patency evaluated by acoustic rhinometry.

Time frame: 21 days

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.

Secondary outcomes

Efficacy of Beclometasone nasal spray on subjective nasal symptoms

Time frame: 21 days

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).

Sponsors and collaborators

Lead sponsor

Stefania La Grutta, MD

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jan 6, 2016
Registry last updated: Nov 20, 2017

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.

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Completed