TY - JOUR
T1 - The effectiveness of once-daily dosing of inhaled flunisolide in maintaining asthma control
AU - ZuWallack, Richard L.
AU - Rosen, James P.
AU - Cohen, Leonard
AU - Rachelefsky, Gary S.
AU - Gong, Henry
AU - Goldsobel, Alan B.
AU - Kaliner, Michael A.
AU - White, Martha V.
AU - Bronsky, Edwin A.
AU - Chervinsky, Paul
AU - Lotner, Gary Z.
AU - Corren, Jonathan
AU - Bodenheimer, Saul
N1 - Funding Information:
Supported by Forest Laboratories, Inc., New York, N.Y.
PY - 1997
Y1 - 1997
N2 - 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), FEV1, and methacholine PC20. 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 PC20 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.
AB - 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), FEV1, and methacholine PC20. 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 PC20 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.
KW - Asthma
KW - Daily dosing
KW - Inhaled steroids
KW - Outcome measures
UR - https://www.scopus.com/pages/publications/18844464751
U2 - 10.1016/S0091-6749(97)70043-5
DO - 10.1016/S0091-6749(97)70043-5
M3 - Article
C2 - 9058681
AN - SCOPUS:18844464751
SN - 0091-6749
VL - 99
SP - 278
EP - 285
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 3
ER -