Clinical trial NCT05325489: Comparison of Nebulized Budesonide and Intranasal Budesonide Spray in Children With Adenotonsillar Hypertrophy
Official title: Comparison Between the Effect of Nebulized Budesonide and Intranasal Budesonide Spray on Children With Adenotonsillar Hypertrophy: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Snoring
Mouth Breathing
Keywords: adenotonsillar hypertrophy
Nebulization
Intranasal Budesonide Spray
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adenoid Size
timeFrame: 1 month
measure: Clinical responses including 9 symptoms (hard to awaken, witnessed apnea, breathing difficulties, snoring, sweating, mouth breathing, awakenings, restless sleep, wetting the bed)
timeFrame: 1 month
Secondary outcomes:
measure: Tonsillar Size
timeFrame: 1 month
measure: Pediatric Sleep Questionnaire(PSQ) Score
timeFrame: 1 month
measure: Obstructive Sleep Apnea Questionnaire(OSA-18) Score
timeFrame: 1 month
measure: Polysomnography
timeFrame: 1 month
measure: Lung function
timeFrame: 1 month
measure: Nasal nitric oxide
timeFrame: 1 month
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Otolaryngology, Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Department of Otolaryngology, Second Xiangya Hospital, Central South University
name: Shisheng Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1023/a:1011933410898. No abstract available.
citation: 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.
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.