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

Primary Purpose

Snoring, Mouth Breathing

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Nebulized Budesonide
Intranasal Budesonide Spray
Sponsored by
Second Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring focused on measuring adenotonsillar hypertrophy, Nebulization, Intranasal Budesonide Spray

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Otolaryngology, Second Xiangya Hospital, Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nebulized Budesonide

Intranasal Budesonide Spray

Arm Description

Drug: budesonide 0.5mg/2ml Pulmicort Respules budesonide inhalation suspension(BIS) once a day (QD) oral montelukast sodium chewable tablets 4mg QD

Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Tonsillar Size
estimation of oropharyngeal examination before and after the therapy.
Pediatric Sleep Questionnaire(PSQ) Score
Children's parents will be required to complete the PSQ questionnaire at diagnosis and after 1 month of therapy.
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.
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.
Lung function
Children's airway ventilation function will be estimated from lung function examination based on the FEV1/FVC value.
Nasal nitric oxide
Children's nasopharyngeal inflammation will be estimated based on the nasal nitric oxide value.

Full Information

First Posted
April 6, 2022
Last Updated
April 16, 2022
Sponsor
Second Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05325489
Brief Title
Comparison of Nebulized Budesonide and Intranasal Budesonide Spray in Children With Adenotonsillar Hypertrophy
Official Title
Comparison Between the Effect of Nebulized Budesonide and Intranasal Budesonide Spray on Children With Adenotonsillar Hypertrophy: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Mouth Breathing
Keywords
adenotonsillar hypertrophy, Nebulization, Intranasal Budesonide Spray

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nebulized Budesonide
Arm Type
Experimental
Arm Description
Drug: budesonide 0.5mg/2ml Pulmicort Respules budesonide inhalation suspension(BIS) once a day (QD) oral montelukast sodium chewable tablets 4mg QD
Arm Title
Intranasal Budesonide Spray
Arm Type
Active Comparator
Arm Description
Drug: budesonide nasal spray 100μg QD oral montelukast sodium chewable tablets 4mg QD
Intervention Type
Drug
Intervention Name(s)
Nebulized Budesonide
Intervention Description
use 0.5mg/2ml Pulmicort Respules BIS QD and oral montelukast sodium chewable tablets 4mg QD
Intervention Type
Drug
Intervention Name(s)
Intranasal Budesonide Spray
Intervention Description
nasal spray 100μg QD and oral montelukast sodium chewable tablets 4mg QD
Primary Outcome Measure Information:
Title
Adenoid Size
Description
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
Title
Clinical responses including 9 symptoms (hard to awaken, witnessed apnea, breathing difficulties, snoring, sweating, mouth breathing, awakenings, restless sleep, wetting the bed)
Description
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
Secondary Outcome Measure Information:
Title
Tonsillar Size
Description
estimation of oropharyngeal examination before and after the therapy.
Time Frame
1 month
Title
Pediatric Sleep Questionnaire(PSQ) Score
Description
Children's parents will be required to complete the PSQ questionnaire at diagnosis and after 1 month of therapy.
Time Frame
1 month
Title
Obstructive Sleep Apnea Questionnaire(OSA-18) Score
Description
Children's parents will be required to complete the OSA-18 questionnaire at diagnosis and after 1 month of therapy.
Time Frame
1 month
Title
Polysomnography
Description
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
Title
Lung function
Description
Children's airway ventilation function will be estimated from lung function examination based on the FEV1/FVC value.
Time Frame
1 month
Title
Nasal nitric oxide
Description
Children's nasopharyngeal inflammation will be estimated based on the nasal nitric oxide value.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shisheng Li, Ph.D.
Phone
86 15974246564
Email
lissdoctor@csu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shisheng Li, Ph.D.
Organizational Affiliation
Department of Otolaryngology, Second Xiangya Hospital, Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shisheng Li, Ph.D.
Phone
86 15974246564
Email
lissdoctor@csu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10383539
Citation
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.
Results Reference
background
PubMed Identifier
10554112
Citation
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.
Results Reference
background
PubMed Identifier
22869829
Citation
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.
Results Reference
background
PubMed Identifier
31172717
Citation
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.
Results Reference
background

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

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