Comparison of beclomethasone dipropionate aerosol and prednisolone in reversible airways obstruction. Comparison of inhaled budesonide with oral prednisolone at two dose-levels commonly used for the treatment of moderate asthma. Effect of prednisone and beclomethasone dipropionate on airway responsiveness in asthma: a comparative study. Comparison of inhaled beclomethasone dipropionate 1000 micrograms twice daily and oral prednisone 10 mg once daily in asthmatic patients. Bioequivalent doses of budesonide and prednisone in moderate and severe asthma. A comparative study of the efficacy of inhaled beclomethasone and systemic prednisolone in bronchial asthma. Efficiency of inhaled versus oral steroid treatment of chronic asthma. Beclomethasone dipropionate aerosol: a substitute for systemic corticosteroid treatment in bronchial asthma.
This paper describes a double-bond crossover trial of prednisolone and beclomethasone dipropionate aerosol in 38 steroid-dependent patients with reversible diffuse airways obstruction. Altogether there was no difference in the patient's preference of the two treatment groups or in the number of times they used their bronchodilator aerosol, or in the forced expiratory volume in one second, vital capacity, or peak expiratory flow rate in the two treatment groups. The plasma cortisol levels when the patients were on the aerosol were much higher than when they were on prednisolone. The use of inhaled aerosol steroids seems to be preferable as it eliminates the usual complications of oral steroid therapy. The purpose of the study was to compare the anti-asthmatic efficacy of two doses of inhaled budesonide with two doses of oral prednisolone commonly used in clinical practice. The patients studied had not been taking regular inhaled glucocorticosteroids and so there was minimal interference from previous medication. The study was conducted as two double-blind crossovers with a washout period between them - firstly, comparing 400 micrograms budesonide with 5 mg prednisolone per day and secondly, 800 micrograms budesonide with 10 mg prednisolone per day. Lung function and symptoms were improved significantly from run-in by all treatments and improvement on both drugs was dose-dependent. When low-dose treatments were compared, mean morning peak expiratory flow rate was higher during budesonide treatment and, as a result, diurnal variation was significantly less than that during prednisolone treatment. At the higher doses, differences between the drugs were not observed, but this may have been due to the fact that a "ceiling effect" had been reached. To examine the effect of corticosteroids on bronchial hyperresponsiveness, a randomised, double dummy, single blind crossover study was performed in 18 subjects with chronic asthma, comparing the effect of three weeks' treatment with inhaled beclomethasone dipropionate, 1200 micrograms daily, and oral prednisone 12.5 mg daily. The 12 week study began with a three week run in period of baseline treatment, which was continued unchanged throughout the study, and the two treatment periods were separated by a three week washout period. Patients kept daily Airflometer readings and attended the laboratory every three weeks for spirometry and a histamine inhalation test for determining the provocative dose of histamine causing a 20% fall in FEV1 (PD20). The mean FEV1 at the start was 1.9 litres (56% predicted). There was no significant change in PD20 with prednisone treatment, the mean PD20 being 0.56 and 0.59 mumol before and after treatment. There was, however, a significant improvement in PD20 with beclomethasone dipropionate treatment, the geometric mean PD20 being 0.38 and 1.01 mumol before and after treatment (p less than 0.001). There was a small but significant improvement in mean FEV1 after beclomethasone dipropionate treatment--from 1.9 to 2.2 litres--but no change after prednisone. Both medications produced significant and similar improvements in morning and evening Airflometer readings, post-bronchodilator improvement, and diurnal variation. Thus at doses that had similar beneficial effects on lung function beclomethasone dipropionate caused a significant improvement in bronchial hyperresponsiveness whereas prednisone caused no change. The superior topical anti-inflammatory effect of beclomethasone dipropionate may account for the different effects on bronchial hyperresponsiveness. Glucocorticosteroids are widely used as drugs of first choice in the treatment of moderate to severe asthma. The effects of inhaled steroids in high doses have been compared with oral prednisone in asthmatic patients in a double blind crossover study.
                The trial consisted of a two week run in period followed by two four week treatment periods separated by a four week washout. During the treatment period patients took either 1000 micrograms beclomethasone dipropionate twice daily and placebo tablets once daily, or 10 mg prednisone daily in one morning dose and placebo inhaler twice daily. The effects of treatment on the provocative dose of histamine producing a 20% fall in FEV1 (PC20 histamine), peak flow measurements at home, and spirometric measurements in the clinic, as well as on the basal and stimulated plasma cortisol levels were measured.
                Seventeen patients with asthma completed the study. After four weeks of treatment beclomethasone dipropionate showed a significantly better effect on morning peak expiratory flow rate than prednisone. There was a trend to a greater improvement in the PC20 histamine in patients receiving beclomethasone dipropionate than in those receiving prednisone. There were no significant differences in spirometric values, symptom scores, or basal and stimulated cortisol levels between the treatments. The within treatment analysis showed a significant effect of prednisone on stimulated cortisol levels but not of beclomethasone dipropionate.
                Beclomethasone dipropionate 1000 micrograms twice daily has a slightly greater therapeutic effect in this population of asthmatic patients than 10 mg of prednisone once a day with less effect on adrenocortical function. We determined the relative antiasthmatic and systemic glucocorticoid potencies of inhaled budesonide (BUD) versus morning-dose oral prednisone (PRED) in 34 adult patients with asthma over a dose range extending from conventional to high and potentially toxic levels, 3.2 mg of BUD or 40 mg of PRED per day. Changes in symptom frequency and severity, FEV1, and peak expiratory flow rate were measured during a double-blind, double-dummy controlled, crossover protocol. The drugs proved equally effective, provided a sufficient dosage was administered. The dose required to eliminate recurrently disabling asthma relapses in these patients was about 2.0 mg of BUD per day or greater than 40 mg of PRED per day. On the average, BUD doses greater than or equal to 1.84 mg/day/70 kg adult (26.3 micrograms/kg/day) exhibited systemic effects on the 8 AM serum cortisol level and blood eosinophil count equivalent to greater than or equal to 15 mg of PRED per day. The latter doses are known to be associated with steroid-induced complications, such as osteoporosis. However, the level of systemic glucocorticoid activity produced by any particular dose of BUD in these patients was consistently much lower than that produced by the dose of PRED needed to achieve an equivalent level of antiasthmatic response. Thus, the use of high-dose inhaled BUD appears clinically reasonable and ethically acceptable in patients with severe asthma in whom the alternative is their continuing dependency on PRED. nan The therapeutic efficiency of oral vs. inhaled steroid treatment for chronic asthma was compared in several graded-dose, double-blind controlled trials. Inhaled steroid proved significantly more effective than alternate-morning prednisone when the two regimens were compared in the same patients at equivalent levels of systemic glucocorticoid activity. Furthermore, if given in sufficient dosage, inhaled steroids proved equally as effective as oral prednisone given daily, and better tolerated than the latter. The data support a broadening of the therapeutic role of inhaled steroid drugs to include higher dosages and patients with more severe grades of asthma. To facilitate this, concentrated formulations are needed. Until the latter become available to the practitioner, combinations of inhaled plus oral steroid treatment may be used, since these have been shown to improve the efficacy of chronic steroid therapy without worsening its adverse effects. nan
A daily dose of prednisolone 7.5-10 mg/day appears to be equivalent to moderate-high dose inhaled corticosteroids. Side-effects may be present on low doses, so if there is no alternative to oral steroids, the lowest effective dose should be prescribed.