title: Efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler: randomized controlled trial comparing once- and twice-daily dosing in patients with asthma.
abstract: Asthma guidelines recommend titrating maintenance medications to the lowest effective dose. This study assessed the efficacy and tolerability of reducing the frequency of dosing in patients previously controlled with twice-daily budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) to once-daily regimens of BUD/FM pMDI or BUD pMDI. This was a 12-week, randomized, double-blind, double-dummy, placebo (PBO)/active-controlled, multicenter study (N = 752) of patients aged > or =16 years with mild to moderate asthma. After 4-5 weeks on single-blind BUD/FM pMDI 160/9 micrograms twice daily (320/18 micrograms daily), patients with stable asthma received BUD/FM pMDI 160/9 micrograms twice daily (320/18 micrograms daily; morning and evening), BUD/FM pMDI 320/9 micrograms once daily (evening), BUD/FM pMDI 160/9 micrograms once daily (evening), BUD pMDI 320 micrograms once daily (evening), or PBO. BUD/FM (once or twice daily) was more effective (p < or = 0.003) than BUD and PBO on evening peak expiratory flow (primary variable), morning pulmonary function assessments, daily symptoms, and nighttime rescue medication use. Twice-daily BUD/FM was more effective (p < or = 0.05) than both once-daily doses for evening pulmonary function assessments and daytime rescue medication use. All treatments were well tolerated. Once- or twice-daily BUD/FM showed better efficacy than BUD once daily or PBO; results generally were more favorable with twice-daily dosing compared with both once-daily dosing regimens, which had one-half the daily FM dose.
authors.affiliation: Allergy and Asthma Associates, 27800 Medical Center Road, Mission Viejo, CA 92691, USA. weberger@uci.edu
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Bleecker
authors.forename: Liza
authors.initials: L
authors.lastname: O'Dowd
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Miller
authors.forename: William
authors.initials: W
authors.lastname: Mezzanotte
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers / Q000009:adverse effects*; D008875:Middle Aged; D012129:Respiratory Function Tests; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate