CONTROLLED TRIAL OF INHALED BUDESONIDE IN PATIENTS WITH CYSTIC-FIBROSIS AND CHRONIC BRONCHOPULMONARY PSEUDOMONAS-AERUGINOSA INFECTION

The efficacy and safety of anti-inflammatory treatment with inhaled gl ucocorticosteroids in patients with cystic fibrosis (CF) and complicat ing chronic Pseudomonas aeruginosa (P.a.) lung infection was studied i n a placebo-controlled, parallel, double-blind single center trial. Ac tive treatment consisted of budesonide dry powder, 800 mu g twice dail y, delivered from a Turbuhaler(R). The study period covered two succes sive 3-mo intervals between elective courses of intravenous anti-Pseud omonas antibiotics. Fifty-five patients entered the study, with a mean age of 20 yr and in mean FEV1 of 63% of predicted. Analysis of all pa tients entered, irrespective of trial adherence (''intention to treat' '), showed a decrease in FEV1 in the first period of -0.032 L in patie nts on bucdesonide versus -0.187 L ire patients on placebo (p = 0.08), The corresponding figures for the patients adhering to the protocol d uring the first period were -0.017 L versus -0.198 L (p < 0.05, confid ence 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 alw ays a trend in favor of budesonide, as judged by changes in FEV1 and F VC in both 3-mo periods. None of the patients had asthma, hut the pati ents 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 conc lude that inhaled glucocorticosteroids can be of short-term benefit in patients with CF and chronic P.a. infection and that those patients m ost likely to benefit from this treatment are patients with hyperreact ive airways. Prolonged studies in larger number of patients are necess ary to determine the long-term efficacy of this treatment.