RATIONALE: Because asthma prevalence and health care utilization are greater in women than men, we examined the response to budesonide/formoterol (BUD/FM) by gender in asthma patients.METHODS: Post hoc by-gender analyses evaluated predose FEV1 and 12-hour postdose FEV1 in 2 double-blind, 12-week studies (I: NCT00651651 [Clin Ther. 2007;29:823-843]; II: NCT00652002 [Drugs. 2006;66:2235-2254]). Patients ≥12 years with mild to moderate (I) or moderate to severe (II) persistent asthma underwent 2-week run-ins with placebo (I) or BUD pMDI 80μg ×2 inhalations (160μg) bid (II) before randomization to 2 inhalations bid of BUD/FM pMDI (I: 80/4.5μg; II: 160/4.5μg), BUD pMDI (I: 80μg; II: 160μg), FM dry powder inhaler (4.5μg), or placebo.RESULTS: Absolute baseline FEV1 was lower in females (I range: 2.0-2.1L; II: 1.9-2.0L) than males (I: 2.7-2.8L; II: 2.6-2.8L); however, when corrected using % predicted FEV1, baseline values were consistent in females (I: 69.4%-71.0%; II: 67.3%-70.7%) and males (I: 70.9%-73.6%; II: 64.6%-68.6%). Similarly, mean percent changes from baseline to treatment average in predose FEV1 were consistent in females and males receiving BUD/FM (I: 17.0% vs 14.5%; II: 9.4% vs 9.3%), while absolute changes were lower in females (I: 0.3L vs 0.4L; II: 0.1L vs 0.2L). Baseline-adjusted mean 12-hour FEV1 (AUC) at week 2 (primary time point) improved in both genders receiving BUD/FM (I: 0.42L and 0.57L; II: 0.27L and 0.44L); values were lower in females, consistent with absolute changes in predose FEV1.CONCLUSIONS: In males and females receiving BUD/FM pMDI, pulmonary function improvements, using standard corrections for gender, were similar across a range of asthma severity. RATIONALE: Because asthma prevalence and health care utilization are greater in women than men, we examined the response to budesonide/formoterol (BUD/FM) by gender in asthma patients. METHODS: Post hoc by-gender analyses evaluated predose FEV1 and 12-hour postdose FEV1 in 2 double-blind, 12-week studies (I: NCT00651651 [Clin Ther. 2007;29:823-843]; II: NCT00652002 [Drugs. 2006;66:2235-2254]). Patients ≥12 years with mild to moderate (I) or moderate to severe (II) persistent asthma underwent 2-week run-ins with placebo (I) or BUD pMDI 80μg ×2 inhalations (160μg) bid (II) before randomization to 2 inhalations bid of BUD/FM pMDI (I: 80/4.5μg; II: 160/4.5μg), BUD pMDI (I: 80μg; II: 160μg), FM dry powder inhaler (4.5μg), or placebo. RESULTS: Absolute baseline FEV1 was lower in females (I range: 2.0-2.1L; II: 1.9-2.0L) than males (I: 2.7-2.8L; II: 2.6-2.8L); however, when corrected using % predicted FEV1, baseline values were consistent in females (I: 69.4%-71.0%; II: 67.3%-70.7%) and males (I: 70.9%-73.6%; II: 64.6%-68.6%). Similarly, mean percent changes from baseline to treatment average in predose FEV1 were consistent in females and males receiving BUD/FM (I: 17.0% vs 14.5%; II: 9.4% vs 9.3%), while absolute changes were lower in females (I: 0.3L vs 0.4L; II: 0.1L vs 0.2L). Baseline-adjusted mean 12-hour FEV1 (AUC) at week 2 (primary time point) improved in both genders receiving BUD/FM (I: 0.42L and 0.57L; II: 0.27L and 0.44L); values were lower in females, consistent with absolute changes in predose FEV1. CONCLUSIONS: In males and females receiving BUD/FM pMDI, pulmonary function improvements, using standard corrections for gender, were similar across a range of asthma severity.