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

Phase 3

Not yet recruiting

• Conditions: Mouth Breathing; Snoring
• Interventions: Drug: Intranasal Budesonide Spray; Drug: Nebulized Budesonide

• Registration Number: NCT05325489
• Lead Sponsor: Second Xiangya Hospital of Central South University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-13
• Last Update Submitted: 2022-04-16
• Last Update Posted: 2022-04-22
• Primary Completion: 2023-11
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical responses including 9 symptoms (hard to awaken, witnessed apnea, breathing difficulties, snoring, sweating, mouth breathing, awakenings, restless sleep, wetting the bed)	1 month	Children's parents will be required to complete a questionnaire about 9 symptoms at diagnosis and after 1 month of therapy. Answers were scored are on a scale of 0 = never to 4 = most of the time.
Adenoid Size	1 month	Children's adenoid size will be estimated from lateral neck X-ray film based on the adenoidal/nasopharyngeal ratio and from nasal endoscopy based on the ratio of adenoid blocking posterior nostril. Lateral neck X-ray film and nasal endoscopy will be performed before and after the 1-month course.

Secondary Outcome Measures

Name	Time	Method
Lung function	1 month	Children's airway ventilation function will be estimated from lung function examination based on the FEV1/FVC value.
Tonsillar Size	1 month	estimation of oropharyngeal examination before and after the therapy.
Pediatric Sleep Questionnaire(PSQ) Score	1 month	Children's parents will be required to complete the PSQ questionnaire at diagnosis and after 1 month of therapy.
Obstructive Sleep Apnea Questionnaire(OSA-18) Score	1 month	Children's parents will be required to complete the OSA-18 questionnaire at diagnosis and after 1 month of therapy.
Polysomnography	1 month	Children's sleep will be estimated from polysomnography based on the apnea-hypopnea index, obstructive apnea index, time with oxygen saturation below 90% and minimum oxygen saturation value.
Nasal nitric oxide	1 month	Children's nasopharyngeal inflammation will be estimated based on the nasal nitric oxide value.

Trial Locations

Locations (1)

Department of Otolaryngology, Second Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China