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Oral Corticosteroid Therapy in Cystic Fibrosis Patients Hospitalized for Pulmonary Exacerbation^*

A Pilot Study

^* From the Section of Pediatric Pulmonology and Allergy (Dr. Dovey), St. Christopher’s Hospital for Children, Philadelphia, PA; Department of Medicine (Dr. Aitken), University of Washington, Seattle, WA; Department of Pediatrics (Dr. Emerson, Ms. McNamara, and Dr. Gibson), University of Washington School of Medicine/Children’s Hospital and Regional Medical Center, Seattle, WA; and Novartis Institutes-Biomedical (Dr. Waltz), Cambridge, MA.

Correspondence to: Moira L. Aitken, MD, FCCP, Division of Pulmonary and Critical Care Medicine, Box 356522, University of Washington Medical Center, 1959 NE Pacific St, Seattle WA 98195-6522; e-mail: moira{at}u.washington.edu

Abstract

Background: We hypothesized that adding 5 days of prednisone to standard therapy for acute pulmonary exacerbations in patients with cystic fibrosis (CF) would result in a more rapid and greater increase in lung function.

Methods: CF patients with an acute pulmonary exacerbation were randomized to receive oral placebo or prednisone, 2 mg/kg/d up to 60 mg, on days 1 to 5 in addition to standard therapy. Study evaluations on days 1 to 6, 14, and 42 included spirometry, glucose measurements, sputum analysis, and symptom scores.

Results: Twelve subjects were randomized to each arm. The slope of FEV₁ between day 1 and day 6 did not differ between evaluable subjects in the prednisone vs placebo groups (52 mL/d vs 51 mL/d, respectively). Mean increase in FEV₁ percentage of predicted did not differ significantly between prednisone vs placebo groups (day 6 [mean ± SD], 12.2 ± 5.2% vs 8.1 ± 10.5%; day 14, 14.7 ± 8.8% vs 10.2 ± 11.2%, respectively). Sputum inflammatory markers and symptom scores decreased between day 1 and day 14, but mean values did not differ between groups. Glucosuria occurred in six prednisone subjects, two of whom had hyperglycemia develop.

Conclusions: In this pilot study, addition of oral corticosteroids to standard CF pulmonary exacerbation therapy did not result in a statistically significant effect on lung function or sputum markers of inflammation. Based on a trend toward improvement in pulmonary function with prednisone therapy, we obtained information for power calculations for a definitive study: 250 randomized subjects are required to detect a four-percentage-point treatment effect in FEV₁ percentage of predicted at day 14 to discriminate between null and alternative hypotheses.

Key Words: acute pulmonary exacerbation • cystic fibrosis • prednisone