ClinicalTrials.Veeva

Menu

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

C

Central South University

Status and phase

Not yet enrolling
Phase 3

Conditions

Snoring
Mouth Breathing

Treatments

Drug: Nebulized Budesonide
Drug: Intranasal Budesonide Spray

Study type

Interventional

Funder types

Other

Identifiers

NCT05325489
LYG2021091

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

3 to 10 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Nebulized Budesonide
Experimental group
Description:
Drug: budesonide 0.5mg/2ml Pulmicort Respules budesonide inhalation suspension(BIS) once a day (QD) oral montelukast sodium chewable tablets 4mg QD
Treatment:
Drug: Nebulized Budesonide
Intranasal Budesonide Spray
Active Comparator group
Description:
Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD
Treatment:
Drug: Intranasal Budesonide Spray

Trial contacts and locations

1

Loading...

Central trial contact

Shisheng Li, Ph.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems