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

NCT05325489 | Unknown Phase 3

• 1 other identifier: LYG2021091
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Snoring; Mouth Breathing

Keywords

adenotonsillar hypertrophy; Nebulization; Intranasal Budesonide Spray

Outcome Measures

Primary Outcomes (2)

• Adenoid Size

  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.

  1 month

• Clinical responses including 9 symptoms (hard to awaken, witnessed apnea, breathing difficulties, snoring, sweating, mouth breathing, awakenings, restless sleep, wetting the bed)

  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.

  1 month

Secondary Outcomes (6)

• Tonsillar Size

  1 month

• Pediatric Sleep Questionnaire(PSQ) Score

  1 month

• Obstructive Sleep Apnea Questionnaire(OSA-18) Score

  1 month

• Polysomnography

  1 month

• Lung function

  1 month

Study Arms (2)

Nebulized Budesonide

EXPERIMENTAL

Drug: budesonide 0.5mg/2ml Pulmicort Respules budesonide inhalation suspension(BIS) once a day (QD) oral montelukast sodium chewable tablets 4mg QD

Drug: Nebulized Budesonide

Intranasal Budesonide Spray

ACTIVE COMPARATOR

Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD

Drug: Intranasal Budesonide Spray

Interventions

Nebulized Budesonide DRUG

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

Nebulized Budesonide

Intranasal Budesonide Spray DRUG

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

Intranasal Budesonide Spray

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Department of Otolaryngology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

Related Publications (4)

• Thorsson L, Borga O, Edsbacker S. Systemic availability of budesonide after nasal administration of three different formulations: pressurized aerosol, aqueous pump spray, and powder. Br J Clin Pharmacol. 1999 Jun;47(6):619-24. doi: 10.1046/j.1365-2125.1999.00956.x.

  PMID: 10383539 BACKGROUND

• Suman JD, Laube BL, Dalby R. Comparison of nasal deposition and clearance of aerosol generated by nebulizer and an aqueous spray pump. Pharm Res. 1999 Oct;16(10):1648-52. doi: 10.1023/a:1011933410898. No abstract available.

  PMID: 10554112 BACKGROUND

• Goldbart AD, Greenberg-Dotan S, Tal A. Montelukast for children with obstructive sleep apnea: a double-blind, placebo-controlled study. Pediatrics. 2012 Sep;130(3):e575-80. doi: 10.1542/peds.2012-0310. Epub 2012 Aug 6.

  PMID: 22869829 BACKGROUND

• Zhang Y, Lou H, Wang Y, Li Y, Zhang L, Wang C. Comparison of Corticosteroids by 3 Approaches to the Treatment of Chronic Rhinosinusitis With Nasal Polyps. Allergy Asthma Immunol Res. 2019 Jul;11(4):482-497. doi: 10.4168/aair.2019.11.4.482.

  PMID: 31172717 BACKGROUND

MeSH Terms

Conditions

Snoring; Mouth Breathing

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Shisheng Li, Ph.D.

  Department of Otolaryngology, Second Xiangya Hospital, Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shisheng Li, Ph.D.

CONTACT

86 15974246564; lissdoctor@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: April 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: September 1, 2024
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)