Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

Stefania La Grutta, MD

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinitis

Treatments: Drug: Nasal Beclomethasone Dipropionate; Drug: CERCHIO 10 mg/ml OS

Study type: Interventional

Funder types: Other

Identifiers

NCT02646904

9-2015

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups

Beclometasone Dipropionate (BDP)

Experimental group

Description:

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

Treatment:

Drug: Nasal Beclomethasone Dipropionate

CERCHIO 10 mg/ml OS

Active Comparator group

Description:

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.

Treatment:

Drug: CERCHIO 10 mg/ml OS