Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: CERCHIO 10 mg/ml OS; Drug: Nasal Beclomethasone Dipropionate

• Registration Number: NCT02646904
• Lead Sponsor: Stefania La Grutta, MD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-06
• Study Start: 2016-05
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CERCHIO 10 mg/ml OS	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.
Beclometasone Dipropionate (BDP)	Nasal Beclomethasone Dipropionate	Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days.

Primary Outcome Measures

Name	Time	Method
Nasal patency evaluated by acoustic rhinometry.	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 Outcome Measures

Name	Time	Method
Efficacy of Beclometasone nasal spray on subjective nasal symptoms	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).

Trial Locations

Locations (2)

Institute of Biomedicine and Molecular Immunology, IBIM; 🇮🇹 Palermo, Italy

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council; 🇮🇹 Palermo, Sicily, Italy