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

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