Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type EXPERIMENTAL

Budesonide nasal spray (100 mcg bid)

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

Budesonide nasal spray (50 mcg bid

Intervention Type DRUG

Interventions

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Budesonide nasal spray (100 mcg bid)

Intervention Type DRUG

Budesonide nasal spray (50 mcg bid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No