Comparison of two high dose corticosteroid aerosol treatments, beclomethasone dipropionate (1500,Ig/day) and budesonide (1600 ag/day), for chronic asthma

Twenty eight patients with chronic asthma took part in a double blind single crossover controlled trial of inhaled budesonide and inhaled beclomethasone dipropionate, using high doses of 1600 pg and 1500 ug daily respectively. Both drugs were administered by pressurised aerosol inhaler; the inhaler containing budesonide and its matching placebo were fitted with a collapsible spacer device. There was no significant difference in the control of asthma during the two six week treatment periods. There was no significant difference in FEV1 and forced vital capacity after four and six weeks of treatment or in mean morning and evening peak expiratory flow rates for the last 21 days of treatment. There was a small but statistically significant reduction in the daytime wheeze score while they were taking high dose budesonide but there was no difference for daytime activity, cough, and night symptoms. The mean basal cortisol concentrations were significantly lower after six weeks of high dose treatment than before treatment (budesonide p < 0-01, beclomethasone p < 0 05). There was no difference between mean basal cortisol values after six weeks of high dose treatment, and there was no effect on the rise of cortisol obtained after a short tetracosactrin test. High dose inhaled corticosteroids produced few side effects and were well tolerated. The corticosteroid budesonide, which became available in an inhaler form for the treatment of asthma relatively recently, has been shown to be as effective in controlling asthma at dosages of 200 pg twice daily as beclomethasone dipropionate at dosages of 100 pg four times a day.' At these low dosages there are no significant side effects and there is no evidence of adrenal suppression as indicated by 9 am plasma cortisol concentration and the response to a short tetracosactrin (synacthen) test. There is only a limited amount of information on the inhalation of higher doses of these drugs in the treatment of severe chronic asthma. The early studies of Gaddie2 suggested that increasing the daily dose of beclomethasone to 1600 pg produced no improvement in FEV, or forced Address for reprint requests: Dr P Ebden, Glenfield General Hospital, Leicester LE3 9QP. Accepted 28 April 1986 vital capacity (FVC) but that there was adrenal suppression as judged by a significantly lower 30 minutes' stimulated cortisol concentration after a short tetracosactrin test when patients were having this dose than when they were taking lower doses. Several subsequent studies have shown, however, that use of higher doses leads to improved control of asthma. Smith and Hodson3 in a retrospective study found that 27% of steroid dependent asthmatic patients were able to stop oral steroid treatment on the introduction of inhaled treatment with high doses of beclomethasone, usually of 1000pg or more daily, and that 39% of steroid dependent patients were able to reduce their oral steroid treatment. These workers also found4 that in patients taking long term inhaled beclomethasone at a daily dose of 2000 pg there was evidence of adrenal suppression as measured by a short tetracosactrin test. We have conducted a prospective study in patients with chronic asthma, comparing the efficacy of beclomethasone 1500 pg daily with budesonide 869 group.bmj.com on June 21, 2017 Published by http://thorax.bmj.com/ Downloaded from