Hypersensitivity pneumonitis: Lessons from a randomized controlled trial in children.
clinical trials
interstitial lung disease (ILD)
Journal
Pediatric pulmonology
ISSN: 1099-0496
Titre abrégé: Pediatr Pulmonol
Pays: United States
ID NLM: 8510590
Informations de publication
Date de publication:
08 2021
08 2021
Historique:
revised:
22
04
2021
received:
18
03
2021
accepted:
14
05
2021
pubmed:
29
5
2021
medline:
25
11
2021
entrez:
28
5
2021
Statut:
ppublish
Résumé
Hypersensitivity pneumonitis (HP) in children is a severe interstitial lung disease and potentially, a chronic condition, if not treated appropriately. No evidence-based guidelines are available; in particular, the role of systemic glucocorticoid therapy is unclear. The aim of this randomized, double-blind, placebo-controlled, parallel-group, multi-center, phase II trial in pediatric HP was to assess the outcome of HP in children after 6 months of treatment and to compare 3 months of treatment with oral prednisolone or placebo. After 1.5 years and the inclusion of only four children, we terminated the study prematurely. Two of the children randomized to prednisolone did not achieve the predefined response of FVC to normal. One child treated with placebo recovered to normal, similar to another child treated with prednisolone. All children treated with steroids developed drug-related side effects. This uncompleted study illustrates the urgent medical need for evidence-based treatment protocols for this condition. We discuss the hurdles which were specific for completion of this trial in a rare condition. Among other options, we suggest the inclusion of children into an all-age study of HP, as in adults the same questions are unanswered.
Substances chimiques
Glucocorticoids
0
Prednisolone
9PHQ9Y1OLM
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2627-2633Informations de copyright
© 2021 The Authors. Pediatric Pulmonology published by Wiley Periodicals LLC.
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