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

Study Overview
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Brief Summary
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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.

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

Conditions
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Snoring, Mouth Breathing

Intervention / Treatment
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* Drug: Nebulized Budesonide
* Drug: Intranasal Budesonide Spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized Budesonide<br>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<br>* use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD<br>|
| Active Comparator: Intranasal Budesonide Spray<br>Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD | Drug: Intranasal Budesonide Spray<br>* nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenotonsillar hypertrophy, Nebulization, Intranasal Budesonide Spray