Snoring, Mouth Breathing
Conditions
Keywords
adenotonsillar hypertrophy, Nebulization, Intranasal Budesonide Spray
Brief 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.
Interventions
use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD
DRUGIntranasal Budesonide Spray
nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoid Size | 1 month | 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. |
| Clinical responses including 9 symptoms (hard to awaken, witnessed apnea, breathing difficulties, snoring, sweating, mouth breathing, awakenings, restless sleep, wetting the bed) | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obstructive Sleep Apnea Questionnaire(OSA-18) Score | 1 month | Children's parents will be required to complete the OSA-18 questionnaire at diagnosis and after 1 month of therapy. |
| Polysomnography | 1 month | 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. |
| Tonsillar Size | 1 month | estimation of oropharyngeal examination before and after the therapy. |
| Nasal nitric oxide | 1 month | Children's nasopharyngeal inflammation will be estimated based on the nasal nitric oxide value. |
| Lung function | 1 month | Children's airway ventilation function will be estimated from lung function examination based on the FEV1/FVC value. |
| Pediatric Sleep Questionnaire(PSQ) Score | 1 month | Children's parents will be required to complete the PSQ questionnaire at diagnosis and after 1 month of therapy. |
Countries
China
Contacts
Primary ContactShisheng Li, Ph.D.
Outcome results
None listed