Hypersensitivity pneumonitis: Lessons from a randomized controlled trial in children.
Pediatr Pulmonol
; 56(8): 2627-2633, 2021 08.
Article
em En
| MEDLINE
| ID: mdl-34048641
ABSTRACT
INTRODUCTION:
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.METHODS:
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.RESULTS:
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.DISCUSSION:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Doenças Pulmonares Intersticiais
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Alveolite Alérgica Extrínseca
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Guideline
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Qualitative_research
Limite:
Adult
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Child
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Humans
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article