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Hypersensitivity pneumonitis : Lessons from a randomized controlled trial in children
- Publication Year :
- 2021
-
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.
- Subjects :
- Pulmonary and Respiratory Medicine
Adult
Chronic condition
Pediatrics
medicine.medical_specialty
Prednisolone
Medizin
Placebo
law.invention
FEV1/FVC ratio
Randomized controlled trial
Double-Blind Method
law
Medicine
Humans
Child
Glucocorticoids
business.industry
Interstitial lung disease
medicine.disease
Clinical trial
Pediatrics, Perinatology and Child Health
business
Lung Diseases, Interstitial
Hypersensitivity pneumonitis
medicine.drug
Alveolitis, Extrinsic Allergic
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....6fb69c2c87e33eb25855fe715c41e2a1