A randomised trial of oral prednisone for cystic fibrosis pulmonary exacerbation treatment.

Autor:	Waters V; Division of Infectious Diseases, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada Valerie.waters@sickkids.ca.; Translational Medicine, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada., Shaw M; Translational Medicine, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.; Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada., Perrem L; Department of Respiratory Medicine, Children's Health Ireland, Dublin, Ireland., Quon BS; Division of Respiratory Medicine, Department of Medicine, St Paul's Hospital, University of British Columbia, Vancouver, BC, Canada., Tullis E; Division of Respirology and Keenan Research Centre of Li Ka Shing Knowledge Institute, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, ON, Canada., Solomon M; Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada., Rayment JH; Division of Respiratory Medicine, Department of Pediatrics, British Columbia Children's Hospital, University of British Columbia, Vancouver, BC, Canada., Lavoie A; Division of Respiratory Medicine and Critical Care, Department of Medicine, Hotel Dieu Hospital, Montreal, QC, Canada., Tse SM; Division of Respiratory Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada., Daigneault P; Division of Respiratory Medicine, Department of Pediatrics, Centre Hospitalier de l'Université de Quebec, Quebec, QC, Canada., Bilodeau L; Division of Respiratory Medicine, Department of Medicine, Institut de l'Université de Cardiologie et Pneumologie de Quebec, Quebec, QC, Canada., Price A; Division of Respiratory Medicine, Department of Pediatrics, London Health Sciences Centre, London, ON, Canada., Nicholson M; Division of Respiratory Medicine, Department of Medicine, London Health Sciences Centre, London, ON, Canada., Chin M; Division of Respiratory Medicine, Department of Medicine, Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada., Parkins M; Division of Respiratory Medicine, Department of Medicine, University of Calgary, Calgary, AB, Canada., McKinney ML; Division of Pediatric Pulmonary and Sleep Medicine, Department of Pediatrics, Children's Hospital of Los Angeles, Los Angeles, CA, USA., Tam JS; Division of Respirology, Critical Care and Sleep Medicine, Department of Medicine, University of Saskatchewan, Saskatoon, SK, Canada., Stanojevic S; Department of Community Health and Epidemiology, Dalhousie University, Halifax, NS, Canada., Grasemann H; Translational Medicine, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.; Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada., Ratjen F; Translational Medicine, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.; Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
Jazyk:	angličtina
Zdroj:	The European respiratory journal [Eur Respir J] 2024 Jun 06; Vol. 63 (6). Date of Electronic Publication: 2024 Jun 06 (Print Publication: 2024).
DOI:	10.1183/13993003.02278-2023
Abstrakt:	Background: Elevated markers of systemic and pulmonary inflammation are associated with failure to recover lung function following pulmonary exacerbations in people with cystic fibrosis (pwCF). Our aim was to determine whether adjuvant oral prednisone treatment would improve recovery of forced expiratory volume in 1 s (FEV 1 ) % pred in CF pulmonary exacerbations not responding to antibiotic therapy. Methods: This was a randomised, double-blind, placebo-controlled trial in pwCF treated with intravenous antibiotics for a pulmonary exacerbation. At day 7, those who had not returned to >90% baseline FEV 1 % pred were randomised to adjuvant prednisone 1 mg·kg -1 twice daily (maximum 60 mg·day -1 ) or placebo for 7 days. The primary outcome was the difference in proportion of subjects who recovered >90% baseline FEV 1 % pred at day 14 of i.v. antibiotic therapy. Results: 173 subjects were enrolled, with 76 randomised. 50% of subjects in the prednisone group recovered baseline FEV 1 on day 14 compared with 39% of subjects in the placebo group (difference of 11%, 95% CI -11-34%; p=0.34). The mean±sd change in FEV 1 % pred from day 7 to day 14 was 6.8±8.8% predicted in the prednisone group and 4.6±6.9% predicted in the placebo group (mean difference 2.2% predicted, 95% CI -1.5-5.9%; p=0.24). Time to subsequent exacerbation was not prolonged in prednisone-treated subjects (hazard ratio 0.83, 95% CI 0.45-1.53; p=0.54). Conclusions: This study failed to detect a difference in FEV 1 % pred recovery between adjuvant oral prednisone and placebo treatment in pwCF not responding at day 7 of i.v. antibiotic therapy for pulmonary exacerbations. Competing Interests: Conflict of interest: F. Ratjen works as a consultant for Vertex Pharmaceuticals, outside the submitted work. The remaining authors have no potential conflicts of interest to disclose. (Copyright ©The authors 2024. For reproduction rights and permissions contact permissions@ersnet.org.)
Databáze:	MEDLINE
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