Four-times-a-day Dosing Frequency Is Better than a Twice-a-day Regimen in Subjects Requiring a High-dose Inhaled Steroid, Budesonide, to Control Moderate to Severe Asthma

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Abstract
Fifty-three adult asthmatic subjects requiring 800 .mu.g or more of inhaled beclomethasone dipropionate were enrolled in a double-blind parallel group study of 6-month duration to compare the efficacy and side effects of inhaled budesonide in doses of 800, 1,200, and 1,600 .mu.g given two or four times a day (BID or QID). After a two-week observation period to establish baseline, subjects were given the same dose of budesonide as they would be for beclomethasone dipropionate; however, the frequency regimen (BID or QID) was randomly allocated. Subjects were asked to fill diary cards describing their asthamatic symptoms, need for medication, and throat symptoms. They were assessed by a physician every 4 wk, at which time spirometry was performed. Throat swabs were done at every other monthly visit. Cortisol and response to cortisol after synthetic ACTH injection were assessed at the begininning and end of the trial. Thirty-six subjects, half in each group, completed the study. Those on the BID regimen had almost twice as many days with nocturnal asthma and cough and almost three times as many days with disability due to asthma. There were also twice as many relapses in the BID regimen as judged by the clinician. These relapses mainly occurred toward the end of the study. The maximal daily swings in peak expiratory flow rates were slightly greater in the BID group, although this difference was not physiologically significant. Spirometry, cortisol secretion, and the response after synthetic ACTH injection were not significantly different in either group from the beginning to the end of the study. We conclude that a prolonged QID regimen of high dose inhaled steriods offers better clinical control of moderate-to-severe asthma than a BID regimen, without inducing more side effects.