THE EFFECTIVENESS OF ONCE-DAILY DOSING OF INHALED FLUNISOLIDE IN MAINTAINING ASTHMA CONTROL

Objective: The purpose of this study was to evaluate the feasibility o f switching to once-daily (qd) administration of flunisolide in patien ts with asthma that was controlled by twice-daily (bid) dosing of this inhaled steroid. Methods: Three hundred sixty-six adults and children with bronchial asthma that was controlled with inhaled steroids were recruited for this prospective, double-blind, parallel-group study. Af ter a 4-week, stable baseline period of flunisolide administration, 2 inhalations (500 mu g) twice daily, each patient was randomized into o ne of four 12-week flunisolide treatment groups: group 1, 2 inhalation s (500 mu g) bid; group 2, 4 inhalations (1000 mu g) qd in the morning ; group 3, 4 inhalations (1000 mu g) qd in the evening; or group 4, 2 inhalations (500 mu g) qd in the morning. Outcome measures included mo rning and evening asthma symptoms (scale of 0 to 3), daytime and night time albuterol use, morning and evening peak expiratory flow rate (PEF R), FEV(1), and methacholine PC20. In addition, a subset of patients i n each group had 24-hour urinary cortisol levels measured before and a fter randomization. Results: Outcome measures in the four groups mere not significantly different at baseline before randomization. The thre e groups that received maintenance therapy with flunisolide, 1000 mu g daily, did not show significant changes from baseline values and rema ined comparable in all outcome areas. Asthma control in the group rand omized to flunisolide 500 mu g qd, however, deteriorated significantly : morning symptoms increased by 0.21 units (48%), evening symptoms inc reased by 0.15 units (31%), daytime albuterol use increased by 0.42 in halations per day (37%), nighttime albuterol use increased by 0.48 inh alations per night (91%), morning PEFR decreased by 17.1 L/min (4%), a nd evening PEFR decreased by 12.6 L/min (3%). There were no significan t changes in PC20 or 24-hour urinary cortisol levels in any group. Con clusions: For patients with asthma that was stabilized by 2 inhalation s of flunisolide (500 mu g) bid, switching to 4 inhalations (1000 mu g ) gd in either the morning or evening is effective in maintaining asth ma control. Reducing the dose to 2 inhalations (500 mu g) qd in the mo rning, however, leads to a deterioration in asthma control.