Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis

November 17, 2017 updated by: Stefania La Grutta, MD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90146
        • Institute of Biomedicine and Molecular Immunology, IBIM
    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beclometasone Dipropionate (BDP)
Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of Nasal Beclomethasone Dipropionate for 21 days.
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.
Other Names:
  • NBDP
Active Comparator: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal patency evaluated by acoustic rhinometry.
Time Frame: 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.
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Beclometasone nasal spray on subjective nasal symptoms
Time Frame: 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).
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stefania La Grutta, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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