Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646904
• Other study ID #: 9-2015
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2015
• Last updated: November 17, 2017
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Nasal Beclomethasone Dipropionate
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 OS
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stefania La Grutta, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	21 days
Secondary	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).	21 days