Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

NCT02646904 | Completed Phase 4

• 1 other identifier: 9-2015
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of Beclometasone nasal spray on subjective nasal symptoms

  21 days

Study Arms (2)

Beclometasone Dipropionate (BDP)

EXPERIMENTAL

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

Drug: Nasal Beclomethasone Dipropionate

CERCHIO 10 mg/ml OS

ACTIVE COMPARATOR

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.

Drug: CERCHIO 10 mg/ml OS

Interventions

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.

Also known as: NBDP

Beclometasone Dipropionate (BDP)

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.

CERCHIO 10 mg/ml OS

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children 6-16 years of age with a history of AR in the previous year
• T5SS: ≥5 in the last week before enrollment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stefania La Grutta, MD: lead

Study Sites (2)

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

Palermo, Sicily, 90146, Italy

Location

Institute of Biomedicine and Molecular Immunology, IBIM

Palermo, 90146, Italy

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Senior Researcher, Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: January 6, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 20, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (2)