Flunisolide aerosol for treatment of severe, chronic asthma in steroid-independent children.

The efficacy and safety of flunisolide aerosol were studied in 46 steroid-independent children with asthma inadequately controlled by nonsteroid drugs. This was a double-blind, placebo-controlled, parallel study lasting eight weeks. Patients were randomly assigned either flunisolide by inhalation, 0.5 mg twice a day, or placebo. Effectiveness was evaluated daily by symptom scores, by Wright peak flow measurements twice daily, and weekly by spirometry and physical examination. Adrenal function and throat cultures for Candida were evaluated before and after the test-drug treatment period. Flunisolide was administered to 25 patients and 21 received placebo. Most symptom scores were statistically significantly better in flunisolide-treated than in placebo-treated patients; these included severity of wheezing (P = .01), chest tightness (P = .01) and shortness of breath (P = .02), and frequency (P = .001) and severity of asthma attacks (P = .03). In addition, placebo-treated patients used significantly more bronchodilators than flunisolide-treated patients. In the final therapeutic effectiveness evaluation, 72% of flunisolide-treated patients received very good or good ratings, whereas only 29% of placebo-treated patients received these ratings (P = .005). No patient developed thrush, evidence of adrenal suppression, or other severe adverse reaction. Flunisolide aerosol was shown to be effective and safe in controlling asthma in children who were candidates for oral steroid therapy.