Trial intelligence / Profile preview

Nebulized vs Intranasal Budesonide for Adenotonsillar Hypertrophy

NCT05325489Phase 3

Key facts

Status: Unknown
Start: Apr 2022
Primary completion: Nov 2023
Countries: 1
Sponsor: The Second Xiangya Hospital
Modality: Orthosteric Ligands

Drugs: EPI-EE
Conditions: Adenotonsillar hypertrophy (ATH)

Overview

Phase 3, randomised, open-label trial of EPI-EE in Adenotonsillar hypertrophy (ATH) (2 arms), sponsored by The Second Xiangya Hospital. Primary endpoints: Adenoid Size at 1 month and Clinical responses including 9 symptoms at 1 month. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Nebulized Budesonide
Budesonide 0.5mg/2ml nebulized QD + Montelukast 4mg QD
Intranasal Budesonide Spray
Budesonide nasal spray 100μg QD + Montelukast 4mg QD

Who it enrols

Children aged 3-10 years with habitual mouth breathing or snoring due to adenotonsillar hypertrophy, excluding those with craniofacial/neuromuscular abnormalities, acute URI, or prior adenotonsillectomy.

Endpoints

Primary

Adenoid Size1 month
Clinical responses including 9 symptoms1 month

Secondary

Tonsillar Size1 month
Pediatric Sleep Questionnaire Score1 month
Obstructive Sleep Apnea Questionnaire Score1 month
Polysomnography1 month
Lung function1 month
Nasal nitric oxide1 month

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