UnknownPhase 3

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

China100 participantsStarted 2022-04

Plain-language 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.

Who can participate

Age range3 Years – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Adenoid Size

Timeframe: 1 month

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

Trial details

NCT IDNCT05325489

SponsorSecond Xiangya Hospital of Central South University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11

Contact for this trial

Shisheng Li, Ph.D.

86 15974246564 lissdoctor@csu.edu.cn

View on ClinicalTrials.gov More Snoring trials