A Phase 3 interventional study of Nebulized Budesonide and Intranasal Budesonide Spray in Snoring and Mouth Breathing, sponsored by Second Xiangya Hospital of Central South University. Status unknown at 1 site in China. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2022-04-22.
Sponsored by Second Xiangya Hospital of Central South University · Phase 3, Interventional, and Treatment
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.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's planned enrollment of 100 is above the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →Second Xiangya Hospital of Central South University is the lead sponsor of 87 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD
Drug: Intranasal Budesonide Spray
use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD
nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD
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.
Time frame: 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.
Time frame: 1 month
Tonsillar Size
estimation of oropharyngeal examination before and after the therapy.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month
Lung function
Children's airway ventilation function will be estimated from lung function examination based on the FEV1/FVC value.
Time frame: 1 month
Nasal nitric oxide
Children's nasopharyngeal inflammation will be estimated based on the nasal nitric oxide value.
Time frame: 1 month
Plan to share: No
Start is estimated for Apr 2022; primary completion for Nov 2023, 19 months later.
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Budesonide
Second Xiangya Hospital of Central South University