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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05325489
Other study ID # LYG2021091
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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