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Am. J. Respir. Crit. Care Med., Volume 156, Number 4, October 1997, 1190-1196

Controlled Trial of Inhaled Budesonide in Patients with Cystic Fibrosis and Chronic Bronchopulmonary Pseudomonas aeruginosa Infection

HANS BISGAARD, SVEND STENVANG PEDERSEN, KIM GJERUM NIELSEN, MARIANNE SKOV, EVA MOSFELDT LAURSEN, GITTE KRONBORG, CLAUS MICHAEL REIMERT, NIELS H ØIBY, and CHRISTIAN KOCH

Departments of Pediatrics, Infectious Diseases, and Clinical Microbiology and Laboratory of Medical Allergology, National University Hospital, Rigshospitalet, Copenhagen, Denmark

The efficacy and safety of anti-inflammatory treatment with inhaled glucocorticosteroids in patients with cystic fibrosis (CF) and complicating chronic Pseudomonas aeruginosa (P.a.) lung infection was studied in a placebo-controlled, parallel, double-blind single center trial. Active treatment consisted of budesonide dry powder, 800 µg twice daily, delivered from a Turbuhaler®. The study period covered two successive 3-mo intervals between elective courses of intravenous anti-Pseudomonas antibiotics. Fifty-five patients entered the study, with a mean age of 20 yr and a mean FEV1 of 63% of predicted. Analysis of all patients entered, irrespective of trial adherence ("intention to treat"), showed a decrease in FEV1 in the first period of -0.032 L in patients on budesonide versus -0.187 L in patients on placebo (p = 0.08). The corresponding figures for the patients adhering to the protocol during the first period were -0.017 L versus -0.198 L (p < 0.05, confidence interval of the difference: -0.035 to +0.327 L). For all patients entered, as well as for patients adhering to the trial, there was always a trend in favor of budesonide, as judged by changes in FEV1 and FVC in both 3-mo periods. None of the patients had asthma, but the patients on budesonide had a mean improvement in histamine reactivity of +1.15 dose steps over the entire 6-mo period, as opposed to +0.017 dose steps in patients on placebo (p < 0.05). There was also a significant (p = 0.01) correlation between pre-trial histamine reactivity and the change in FEV1 in the first period in patients on budesonide. We conclude that inhaled glucocorticosteroids can be of short-term benefit in patients with CF and chronic P.a. infection and that those patients most likely to benefit from this treatment are patients with hyperreactive airways. Prolonged studies in larger number of patients are necessary to determine the long-term efficacy of this treatment.




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