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A randomized trial of oral prednisone for cystic fibrosis pulmonary exacerbation treatment
PDPI Lampung & Bengkulu, 09 Mei 2024 03:23:26

Valerie Waters, Michelle Shaw, Lucy Perrem, Bradley S. Quon, Elizabeth Tullis, Melinda Solomon, Jonathan H. Rayment, Annick Lavoie, Sze Man Tse, Patrick Daigneault, Lara Bilodeau, April Price, Michael Nicholson, Melanie Chin, Michael Parkins, Martha L. McKinney, Julian S. Tam, Sanja Stanojevic, Hartmut Grasemann, Felix Ratjen PIPE Study Investigators
European Respiratory Journal 2024; DOI: 10.1183/13993003.02278-2023 


Background Elevated markers of systemic and pulmonary inflammation are associated with failure to recover lung function following pulmonary exacerbations (PExs) 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 second (ppFEV1) in CF PExs not responding to antibiotic therapy.

Methods This was a randomized, double-blind, placebo-controlled trial in pwCF treated with intravenous (IV) antibiotics for a PEx. At Day 7, those who had not returned to >90% baseline ppFEV1 were randomized to adjuvant prednisone 1 mg·kg−1 twice daily (max 60 mg/day) or placebo for 7 days. The primary outcome was the difference in proportion of subjects who recovered >90% baseline ppFEV1 at Day 14 of IV antibiotic therapy.

Results 173 subjects were enrolled, with 76 randomized. 50% of subjects in the prednisone group recovered baseline FEV1 on Day 14 compared to 39% of subjects in the placebo group for a difference of 11% (95% CI -11, 34%, p=0.34). The mean (sd) change in ppFEV1 from Day 7 to Day 14 was 6.8% predicted (8.8) in the prednisone group and 4.6% (6.9) 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 (HR 0.83, 95% CI 0.45, 1.53; p=0.54).

Conclusions This study failed to detect a difference in ppFEV1 recovery between adjuvant oral prednisone and placebo treatment in pwCF not responding at day 7 of IV antibiotic therapy for PExs.

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