search
Back to results

Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Nasal Beclomethasone Dipropionate
CERCHIO 10 mg/ml OS
Sponsored by
Stefania La Grutta, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Beclometasone Dipropionate (BDP)

CERCHIO 10 mg/ml OS

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
December 18, 2015
Last Updated
November 17, 2017
Sponsor
Stefania La Grutta, MD
search

1. Study Identification

Unique Protocol Identification Number
NCT02646904
Brief Title
Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
Official Title
Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stefania La Grutta, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beclometasone Dipropionate (BDP)
Arm Type
Experimental
Arm Description
Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days.
Arm Title
CERCHIO 10 mg/ml OS
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nasal Beclomethasone Dipropionate
Other Intervention Name(s)
NBDP
Intervention Description
Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days.
Intervention Type
Drug
Intervention Name(s)
CERCHIO 10 mg/ml OS
Intervention 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.
Primary Outcome Measure Information:
Title
Nasal patency evaluated by acoustic rhinometry.
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Efficacy of Beclometasone nasal spray on subjective nasal symptoms
Description
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).
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
City
Palermo
State/Province
Sicily
ZIP/Postal Code
90146
Country
Italy
Facility Name
Institute of Biomedicine and Molecular Immunology, IBIM
City
Palermo
ZIP/Postal Code
90146
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD collected will be available on February 2017. The following participant data will be shared: Nasal patency Nasal symptom score Demographic characteristics All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.

Learn more about this trial

Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

We'll reach out to this number within 24 hrs