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

NCT05325489 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Snoring
  • Mouth Breathing

Interventions

DRUG

Nebulized Budesonide

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

DRUG

Intranasal Budesonide Spray

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

Sponsors & Collaborators

  • Second Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Shisheng Li, Ph.D. · Department of Otolaryngology, Second Xiangya Hospital, Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2023-11-30
Completion
2024-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05325489 on ClinicalTrials.gov