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

Comparison Between the Effect of Nebulized Budesonide and Intranasal Budesonide Spray on Children With Adenotonsillar Hypertrophy: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Snoring; Mouth Breathing
• Intervention / Treatment: Drug: Nebulized Budesonide; Drug: Intranasal Budesonide Spray

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shisheng Li, Ph.D.; Phone Number: 86 15974246564; Email: lissdoctor@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Department of Otolaryngology, Second Xiangya Hospital, Central South University
      • Contact: Shisheng Li, Ph.D.; Phone Number: 86 15974246564; Email: lissdoctor@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nebulized Budesonide; 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; use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD
Active Comparator: Intranasal Budesonide Spray; Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD	Drug: Intranasal Budesonide Spray; nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tonsillar Size	estimation of oropharyngeal examination before and after the therapy.	1 month
Pediatric Sleep Questionnaire(PSQ) Score	Children's parents will be required to complete the PSQ questionnaire at diagnosis and after 1 month of therapy.	1 month
Obstructive Sleep Apnea Questionnaire(OSA-18) Score	Children's parents will be required to complete the OSA-18 questionnaire at diagnosis and after 1 month of therapy.	1 month
Polysomnography	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.	1 month
Lung function	Children's airway ventilation function will be estimated from lung function examination based on the FEV1/FVC value.	1 month
Nasal nitric oxide	Children's nasopharyngeal inflammation will be estimated based on the nasal nitric oxide value.	1 month

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Investigators: Principal Investigator: Shisheng Li, Ph.D., Department of Otolaryngology, Second Xiangya Hospital, Central South University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 16, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: adenotonsillar hypertrophy; Nebulization; Intranasal Budesonide Spray
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Anatomical; Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring; Hypertrophy; Mouth Breathing; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: LYG2021091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No