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

Abstract

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 (FEV₁) % 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 FEV₁ % 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 FEV₁ % 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 FEV₁ 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 FEV₁ % 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 FEV₁ % pred recovery between adjuvant oral prednisone and placebo treatment in pwCF not responding at day 7 of i.v. antibiotic therapy for pulmonary exacerbations.