A Trial of Intranasal Corticosteroids to Treat Childhood OSA Syndrome.
double-blind method
fluticasone
intention-to-treat analysis
randomized controlled trial
Journal
Chest
ISSN: 1931-3543
Titre abrégé: Chest
Pays: United States
ID NLM: 0231335
Informations de publication
Date de publication:
10 2022
10 2022
Historique:
received:
02
12
2021
revised:
03
06
2022
accepted:
14
06
2022
pubmed:
3
7
2022
medline:
12
10
2022
entrez:
2
7
2022
Statut:
ppublish
Résumé
Intranasal corticosteroids (INCS) are frequently used to treat OSA syndrome (OSAS) in children. However, their efficacy has not been rigorously tested. Do INCS result in improved OSAS symptoms, polysomnography findings, behavior, and quality of life compared with placebo? In this randomized, double-blind, placebo-controlled trial, children with OSAS aged 5 to 12 years (N = 134) were randomized 2:1 to receive 3 months of INCS or placebo. Children in the INCS arm were then re-randomized to receive 9 months of INCS or placebo. Polysomnography, symptoms, and neurobehavioral findings were measured at baseline, 3 months, and 12 months. The primary outcome was change in obstructive apnea hypopnea index (OAHI) at 3 months, available for 122 children. The secondary outcome was OAHI change at 12 months, available for 70 children. Median (interquartile range) age and OAHI at baseline for the entire group were 7.9 (6.3 to 9.9) years and 5.8 (3.6 to 9.7) events per hour. OAHI changes at 3 months (-1.72 [-3.91 to 1.92] events per hour) and 12 months (-1.2 [-4.22 to 1.71] events per hour) were not different between the two groups (P = not significant). OSAS symptoms and neurobehavioral results did not differ between the INCS and placebo groups at 3 and 12 months. The 38 children who received INCS for 12 months reported a significant OAHI decrease from 7.2 (3.62 to 9.88) events per hour to 3.7 (1.56 to 6.4) events per hour (P = .039). In children with OSAS, treatment with INCS did not result in significant polysomnography, neurobehavioral, or symptom changes at 3 and 12 months of treatment. Twelve months of INCS treatment resulted in a statistically significant but not clinically relevant OAHI reduction. ClinicalTrials.gov; No.: NCT02180672; URL: www. gov.
Sections du résumé
BACKGROUND
Intranasal corticosteroids (INCS) are frequently used to treat OSA syndrome (OSAS) in children. However, their efficacy has not been rigorously tested.
RESEARCH QUESTION
Do INCS result in improved OSAS symptoms, polysomnography findings, behavior, and quality of life compared with placebo?
STUDY DESIGN AND METHODS
In this randomized, double-blind, placebo-controlled trial, children with OSAS aged 5 to 12 years (N = 134) were randomized 2:1 to receive 3 months of INCS or placebo. Children in the INCS arm were then re-randomized to receive 9 months of INCS or placebo. Polysomnography, symptoms, and neurobehavioral findings were measured at baseline, 3 months, and 12 months. The primary outcome was change in obstructive apnea hypopnea index (OAHI) at 3 months, available for 122 children. The secondary outcome was OAHI change at 12 months, available for 70 children.
RESULTS
Median (interquartile range) age and OAHI at baseline for the entire group were 7.9 (6.3 to 9.9) years and 5.8 (3.6 to 9.7) events per hour. OAHI changes at 3 months (-1.72 [-3.91 to 1.92] events per hour) and 12 months (-1.2 [-4.22 to 1.71] events per hour) were not different between the two groups (P = not significant). OSAS symptoms and neurobehavioral results did not differ between the INCS and placebo groups at 3 and 12 months. The 38 children who received INCS for 12 months reported a significant OAHI decrease from 7.2 (3.62 to 9.88) events per hour to 3.7 (1.56 to 6.4) events per hour (P = .039).
INTERPRETATION
In children with OSAS, treatment with INCS did not result in significant polysomnography, neurobehavioral, or symptom changes at 3 and 12 months of treatment. Twelve months of INCS treatment resulted in a statistically significant but not clinically relevant OAHI reduction.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov; No.: NCT02180672; URL: www.
CLINICALTRIALS
gov.
Identifiants
pubmed: 35779610
pii: S0012-3692(22)01198-9
doi: 10.1016/j.chest.2022.06.026
pmc: PMC9633812
pii:
doi:
Substances chimiques
Adrenal Cortex Hormones
0
Banques de données
ClinicalTrials.gov
['NCT02180672']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
899-919Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL120909
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001878
Pays : United States
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2022 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
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