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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized Budesonide | Experimental | Drug: budesonide 0.5mg/2ml Pulmicort Respules budesonide inhalation suspension(BIS) once a day (QD) oral montelukast sodium chewable tablets 4mg QD |
|
| Intranasal Budesonide Spray | Active Comparator | Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized Budesonide | Drug | use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shisheng Li, Ph.D. | Contact | 86 15974246564 | lissdoctor@csu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shisheng Li, Ph.D. | Department of Otolaryngology, Second Xiangya Hospital, Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otolaryngology, Second Xiangya Hospital, Central South University | Changsha | Hunan | 410011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10383539 | Background | 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. | |
| 10554112 | Background | 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. |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| D009058 | Mouth Breathing |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Intranasal Budesonide Spray | Drug | nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD |
|
| 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 |
| 22869829 | Background | 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. |
| 31172717 | Background | 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. |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |