Oral Corticosteroid Therapy in Cystic Fibrosis Patients Hospitalized for Pulmonary Exacerbation: A Pilot Study

摘要

Background: We hypothesized that adding 5 days of prednisone to standard therapy for acutenpulmonary exacerbations in patients with cystic fibrosis (CF) would result in a more rapid andngreater increase in lung function.nMethods: CF patients with an acute pulmonary exacerbation were randomized to receive oralnplacebo or prednisone, 2 mg/kg/d up to 60 mg, on days 1 to 5 in addition to standard therapy.nStudy evaluations on days 1 to 6, 14, and 42 included spirometry, glucose measurements, sputumnanalysis, and symptom scores.nResults: Twelve subjects were randomized to each arm. The slope of FEV1 between day 1 and dayn6 did not differ between evaluable subjects in the prednisone vs placebo groups (52 mL/d vs 51nmL/d, respectively). Mean increase in FEV1 percentage of predicted did not differ significantlynbetween prednisone vs placebo groups (day 6 [mean u0001 SD], 12.2 u0001 5.2% vs 8.1 u0001 10.5%; day 14,n14.7 u0001 8.8% vs 10.2 u0001 11.2%, respectively). Sputum inflammatory markers and symptom scoresndecreased between day 1 and day 14, but mean values did not differ between groups. Glucosurianoccurred in six prednisone subjects, two of whom had hyperglycemia develop.nConclusions: In this pilot study, addition of oral corticosteroids to standard CF pulmonarynexacerbation therapy did not result in a statistically significant effect on lung function or sputumnmarkers of inflammation. Based on a trend toward improvement in pulmonary function withnprednisone therapy, we obtained information for power calculations for a definitive study: 250nrandomized subjects are required to detect a four-percentage-point treatment effect in FEV1npercentage of predicted at day 14 to discriminate between null and alternative hypotheses.