The effectiveness of once-daily dosing of inhaled flunisolide in maintaining asthma control

• Published in: Journal of allergy and clinical immunology Vol. 99; no. 3; pp. 278 - 285
• Main Authors: ZuWallack, Richard L., Rosen, James P., Cohen, Leonard, Rachelefsky, Gary S., Gong, Henry, Goldsobel, Alan B., Kaliner, Michael A., White, Martha V., Bronsky, Edwin A., Chervinsky, Paul, Lotner, Gary Z., Corren, Jonathan, Bodenheimer, Saul
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01-03-1997; Elsevier
• Subjects: Administration, Inhalation; Adolescent; Adult; Albuterol - therapeutic use; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - therapeutic use; Asthma; Asthma - drug therapy; Biological and medical sciences; Bronchial Provocation Tests; Bronchodilator Agents - therapeutic use; Child; daily dosing; Double-Blind Method; Female; Fluocinolone Acetonide - administration & dosage; Fluocinolone Acetonide - analogs & derivatives; Fluocinolone Acetonide - therapeutic use; Forced Expiratory Volume; Humans; Hydrocortisone - analysis; Hydrocortisone - urine; inhaled steroids; Male; Medical sciences; Methacholine Chloride - pharmacology; Middle Aged; outcome measures; Peak Expiratory Flow Rate; Pharmacology. Drug treatments; Respiratory system; qd; PEFR; outcome measures; daily dosing; inhaled steroids; bid; Asthma; Human; Corticosteroid; Flunisolide; Respiratory disease; Antiinflammatory agent; Administration schedule; Glucocorticoid; Inhalation; Chemotherapy; Treatment; Single daily dose; Obstructive pulmonary disease
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/S0091-6749(97)70043-5

Objective: The purpose of this study was to evaluate the feasibility of switching to once-daily (qd) administration of flunisolide in patients 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. After a 4-week, stable baseline period of flunisolide administration, 2 inhalations (500 μg) twice daily, each patient was randomized into one of four 12-week flunisolide treatment groups: group 1, 2 inhalations (500 μg) bid; group 2, 4 inhalations (1000 μg) qd in the morning; group 3, 4 inhalations (1000 μg) qd in the evening; or group 4, 2 inhalations (500 μg) qd in the morning. Outcome measures included morning and evening asthma symptoms (scale of 0 to 3), daytime and nighttime albuterol use, morning and evening peak expiratory flow rate (PEFR), FEV
1, and methacholine PC
20. In addition, a subset of patients in each group had 24-hour urinary cortisol levels measured before and after randomization.
Results: Outcome measures in the four groups were not significantly different at baseline before randomization. The three groups that received maintenance therapy with flunisolide, 1000 μg daily, did not show significant changes from baseline values and remained comparable in all outcome areas. Asthma control in the group randomized to flunisolide 500 μg qd, however, deteriorated significantly: morning symptoms increased by 0.21 units (48%), evening symptoms increased by 0.15 units (31%), daytime albuterol use increased by 0.42 inhalations per day (37%), nighttime albuterol use increased by 0.48 inhalations per night (91%), morning PEFR decreased by 17.1 L/min (4%), and evening PEFR decreased by 12.6 L/min (3%). There were no significant changes in PC
20 or 24-hour urinary cortisol levels in any group.
Conclusions: For patients with asthma that was stabilized by 2 inhalations of flunisolide (500 μg) bid, switching to 4 inhalations (1000 μg) qd in either the morning or evening is effective in maintaining asthma control. Reducing the dose to 2 inhalations (500 μg) qd in the morning, however, leads to a deterioration in asthma control. (J Allergy Clin Immunol 1997;99:278-85.)