Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

January 8, 2018 updated by: Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

Effectiveness of Nasal Budesonide on Control of Airway Inflammation by Determining FeNO in Children With Allergic Rhinitis.

In clinical trials for treatment of allergic rhinitis a significant reduction of the total symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous results in adults show that the assessment and monitoring del nasal fractional exhaled nitric oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis.

Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous solution) on the nasal inflammation marker (nFeNO).

Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total Symptom Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported sleep quality (Pittsburgh Sleep Quality Index, PSQI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

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
    • 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 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • history of allergic rhinitis for at least 1 year
  • children aged 6 - 14 years
  • Total Symptom Score (T5SS) more than 6 in the last 4 days before the screening visit

Exclusion Criteria:

  • signs of acute respiratory infection
  • systemic immunological and metabolic disease
  • major malformations of the upper airways
  • topical or systemic therapy with antibiotics, antihistamines and corticosteroids in the 30 days prior to the study
  • patient active smoker

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Budesonide nasal (100 mcg bid)
The study will be randomized, controlled parallel group. After 1 week of phase baseline screening (Visit 1), patients will be randomized (1:4) with the assignment of a code (B-200_da 01 to 08, B-100_ 01 to 31) (day 0, Visit 2) in 2 groups: N1 (n = 8) = Budesonide nasal spray 100 mcg, 2 v / d; Patients return to control after the 1st week (day 7, Visit 3), after the 2nd week (day 14, Visit 4) and one week after the end of the treatment period (day 21, Visit 5). It will give a tolerance of ± 3 days for the timing of planned visits. In the phase of follow-up, (3 days after the last dose of drug) will be recorded the occurrence of adverse effects (Adverse Event, EA)
Drug: Budesonide nasal spray (100 mcg bid)
Experimental: Budesonide nasal (50 mcg bid)
The study will be randomized, controlled parallel group. After 1 week of phase baseline screening (Visit 1), patients will be randomized (1:4) with the assignment of a code (B-200_da 01 to 08, B-100_ 01 to 31) (day 0, Visit 2) in 2 groups: ; N2 (n = 31) = Budesonide nasal spray 50 mcg, 2 v / d. Patients return to control after the 1st week (day 7, Visit 3), after the 2nd week (day 14, Visit 4) and one week after the end of the treatment period (day 21, Visit 5). It will give a tolerance of ± 3 days for the timing of planned visits. In the phase of follow-up, (3 days after the last dose of drug) will be recorded the occurrence of adverse effects (Adverse Event, EA)
Drug: Budesonide nasal spray (50 mcg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal nitric oxide (nFeNO)
Time Frame: 21 days
Assessment of the influence of nasal Budesonide (aqueous solution) on nasal FeNo (nFeNO) in children with allergic rhinitis.
21 days

Collaborators and Investigators

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

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/2013 (Other Grant/Funding Number: The Medical University of Warsaw)
  • Ethics Committee Approval (Other Identifier: Inonu University Ethics Committee Approval No: 2024/6279)

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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