Multicenter study of flunisolide aerosol in adult patients with steroid-dependent asthma.
Seventy-three adult, steroid-dependent asthmatic patients participated in a 16-wk, double-blind study testing the efficacy of flunisolide aerosol. Forty received flunisolide, and 33 received placebo. The mean daily prednisone requirement of patients receiving flunisolide fell 59.2% during the testing period, and that of the patients receiving placebo fell 19.7%. The median daily prednisone dose dropped 74.4% in the flunisolide group and 4.2% in the placebo group (p = 0.006). In the flunisolide group 75% tapered use of oral steroids 50% or more, and 27.5% stopped taking oral steroids completely. In the placebo group 36% tapered use of oral steroids 50% or more, and only 12% stopped taking them completely. Despite their reduction in systemic steroids, those patients receiving flunisolide achieved significantly greater reduction in the daily severity of wheezing (p = 0.014) and frequency of asthma attacks (p = 0.049) than did those receiving placebo. In the final evaluation of therapeutic response, 70% of patients receiving flunisolide were rated as having a very good or good response, and 30% were rated as having a fair or poor response. In contrast 33% of patients receiving placebo were rated as very good or good, and 67% were rated as fair or poor (p = 0.0009). No serious reactions were reported. Plasma cortisols showed an average increase of 42.9% in the flunisolide group but no change in the placebo group. Flunisolide aerosol is a well-tolerated and effective agent in the treatment of steroid-dependent asthma.
D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005446:Fluocinolone Acetonide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005541:Forced Expiratory Volume; D006801:Humans; D008450:Maximal Midexpiratory Flow Rate; D008875:Middle Aged; D010919:Placebos; D011241:Prednisone / Q000627:therapeutic use; D013256:Steroids / Q000627:therapeutic use*
D000336:Aerosols; D010919:Placebos; D013256:Steroids; D005446:Fluocinolone Acetonide; C007734:flunisolide; D011241:Prednisone