Document Classification

Section Type: METHODS

Text: This 12-week, double-blind, double-dummy, placebo-controlled, multicenter study randomized 596 patients 12 years or older to budesonide/formoterol pMDI 160/4. 5 microg x 2 inhalations (320/9 microg) ; budesonide pMDI 160 microg x 2 inhalations (320 microg) + formoterol dry powder inhaler (DPI) 4. 5 microg x 2 inhalations (9 microg) ; budesonide pMDI 160 microg x 2 inhalations (320 microg) ; formoterol DPI 4. 5 microg x 2 inhalations (9 microg) ; or placebo, each twice daily, after 2 weeks of budesonide pMDI 80 microg x 2 inhalations (160 microg) twice daily.