Comparison of Nebulized Budesonide and Intranasal Budesonide Spray in Children With Adenotonsillar Hypertrophy

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2024-09-30

Brief Summary

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Budesonide is one of the most common drugs uesd in children with adenotonsillar hypertrophy. This study aim to evaluate the efficacy of a short course of budesonide inhalation suspension via transnasal nebulization in children with adenotonsillar hypertrophy. The second aim is to compare budesonide inhalation suspension with budesonide aqueous nasal spray in adenotonsillar hypertrophy treatment.

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Detailed Description

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Conditions

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Snoring Mouth Breathing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nebulized Budesonide

Drug: budesonide 0.5mg/2ml Pulmicort Respules budesonide inhalation suspension(BIS) once a day (QD) oral montelukast sodium chewable tablets 4mg QD

Group Type EXPERIMENTAL

Nebulized Budesonide

Intervention Type DRUG

use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD

Intranasal Budesonide Spray

Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD

Group Type ACTIVE_COMPARATOR

Intranasal Budesonide Spray

Intervention Type DRUG

nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD

Interventions

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Nebulized Budesonide

use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD

Intervention Type DRUG

Intranasal Budesonide Spray

nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children are ≥3 years and ≤10 years, have habitual mouth breathing or snoring, and without current or previous use of any corticosteroids or leukotriene receptor inhibitors within 4 weeks preceding the initial study.

Exclusion Criteria

* Children with craniofacial, neuromuscular, syndromic, or defined genetic abnormalities; acute upper respiratory tract infection; whose symptoms are not caused by adenotonsillar hypertrophy; and who have had adenotonsillectomy in the past.

Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No