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

Snoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05325489
• Other study ID #: LYG2021091
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2022
• Source: Second Xiangya Hospital of Central South University
• Contact: Shisheng Li, Ph.D.
• Phone: 86 15974246564
• Email: lissdoctor[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertrophy
• Mouth Breathing
• Snoring

Intervention

Drug:
• Nebulized Budesonide
use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD
• Intranasal Budesonide Spray
nasal spray 100µg QD and oral montelukast sodium chewable tablets 4mg QD

Locations

Country	Name	City	State
China	Department of Otolaryngology, Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

Thorsson L, Borgâ O, Edsbäcker 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Tonsillar Size	estimation of oropharyngeal examination before and after the therapy.	1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	Lung function	Children's airway ventilation function will be estimated from lung function examination based on the FEV1/FVC value.	1 month
Secondary	Nasal nitric oxide	Children's nasopharyngeal inflammation will be estimated based on the nasal nitric oxide value.	1 month