BACKGROUND: The goal of asthma therapy is to control symptoms using minimal pharmacologic intervention. OBJECTIVE: To evaluate the efficacy and tolerability of once-daily budesonide/formoterol vs once-daily budesonide in patients stable with twice-dailybudesonide/formoterol. METHODS: This double-blind, 12-week study enrolled 619 patients 12 years and older with mild to moderate asthma. After 4 to 5 weeks of twice-daily budesonide/formoterol pressurized metered-dose inhaler (pMDI), 80/4.5 microg x 2 inhalations (320/18 microg/d), stable patients were randomized 1:1:1:1 to 2 inhalations twice daily of budesonide/formoterol pMDI, 80/4.5 microg (320/18 microg/d), or 2 inhalations once daily (evening) of budesonide/formoterol pMDI, 160/4.5 microg or 80/4.5 microg (320/9 microg or 160/9 microg/d), or budesonide pMDI, 160 microg (320 microg/d). RESULTS: All budesonide/formoterol groups maintained significantly more favorable evening predose forced expiratory volume in 1 second (FEV1), morning peak expiratory flow (PEF), daytime/nighttime asthma symptoms, nighttime rescue medication use, and rescue medication-free days vs budesonide. Variables evaluated during the end of the once-daily dosing interval (evening predose FEV1, evening PEF, daytime asthma symptoms, and daytime rescue medication use) significantly favored twice-daily budesonide/formoterol vs all treatments. Twice-daily budesonide/formoterol demonstrated significantly more favorable results for symptom-free and asthma control days vs all treatments and awakening-free nights vs budesonide. Asthma Quality of Life Questionnaire and Asthma Control Questionnaire results significantly favored twice-daily budesonide/formoterol vs budesonide (P < or = .018). All treatments were well tolerated. CONCLUSIONS: Pulmonary function and asthma control were more effectively maintained with all budesonide/formoterol regimens vs once-daily budesonide and with twice-daily budesonide/formoterol at twice the daily formoterol dose vs both once-daily budesonide/formoterol doses.
RCT Entities:
BACKGROUND: The goal of asthma therapy is to control symptoms using minimal pharmacologic intervention. OBJECTIVE: To evaluate the efficacy and tolerability of once-daily budesonide/formoterol vs once-daily budesonide in patients stable with twice-daily budesonide/formoterol. METHODS: This double-blind, 12-week study enrolled 619 patients 12 years and older with mild to moderate asthma. After 4 to 5 weeks of twice-daily budesonide/formoterol pressurized metered-dose inhaler (pMDI), 80/4.5 microg x 2 inhalations (320/18 microg/d), stable patients were randomized 1:1:1:1 to 2 inhalations twice daily of budesonide/formoterol pMDI, 80/4.5 microg (320/18 microg/d), or 2 inhalations once daily (evening) of budesonide/formoterol pMDI, 160/4.5 microg or 80/4.5 microg (320/9 microg or 160/9 microg/d), or budesonide pMDI, 160 microg (320 microg/d). RESULTS: All budesonide/formoterol groups maintained significantly more favorable evening predose forced expiratory volume in 1 second (FEV1), morning peak expiratory flow (PEF), daytime/nighttime asthma symptoms, nighttime rescue medication use, and rescue medication-free days vs budesonide. Variables evaluated during the end of the once-daily dosing interval (evening predose FEV1, evening PEF, daytime asthma symptoms, and daytime rescue medication use) significantly favored twice-daily budesonide/formoterol vs all treatments. Twice-daily budesonide/formoterol demonstrated significantly more favorable results for symptom-free and asthma control days vs all treatments and awakening-free nights vs budesonide. Asthma Quality of Life Questionnaire and Asthma Control Questionnaire results significantly favored twice-daily budesonide/formoterol vs budesonide (P < or = .018). All treatments were well tolerated. CONCLUSIONS: Pulmonary function and asthma control were more effectively maintained with all budesonide/formoterol regimens vs once-daily budesonide and with twice-daily budesonide/formoterol at twice the daily formoterol dose vs both once-daily budesonide/formoterol doses.