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- W1996884860 abstract "RationaleThe influence of FAO on asthma treatment response in African-American patients with asthma is unclear.MethodsThis 12-week, randomized, double-blind study (NCT00702325) was conducted in moderate–severe African-American (self-reported) patients with asthma aged ≥12 years previously receiving medium- to high-dose inhaled corticosteroid (J Asthma.2012;49:70-77). Percentage of patients achieving ≥100mL improvement in FEV1, ≥100mL improvement in FVC, and ≥0 decrease (inhalations/day) in rescue medication use from baseline to randomized treatment period mean (responders) were stratified by FAO category(screening post albuterol forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <0.70[with] or ≥0.70[without]) in the twice-daily BUD/FM pMDI 320/9 μg (n=37[with], n=119[without]) and BUD dry powder inhaler(DPI) 360 μg(n=34[with], n=121[without]) arms after a 2-week run-in on twice-daily BUD DPI 180mg.ResultsBaseline characteristics suggested a greater degree of impairment in patients with versus without FAO. In the BUD/FM group, the percentages of patients meeting response criteria for FEV1, FVC, and rescue medication use were similar or higher in patients with versus without FAO(62.2% vs 51.3%, 54.1% vs 49.6%, and 70.3% vs 70.6%, respectively). The percentages of FEV1, FVC, and rescue medication use responders in patients with versus without FAO were 29.4% vs 42.1%, 29.4% vs 41.3%, and 61.8% vs 60.3%, respectively, in BUD patients.ConclusionsIn this African-American population of patients with moderate to severe asthma, a robust response to BUD/FM was observed across multiple control metrics, irrespective of the presence of FAO. A substantially greater percentage of patients with FAO receiving BUD/FM pMDI versus BUD DPI exhibited meaningful improvements in FEV1 and FVC. RationaleThe influence of FAO on asthma treatment response in African-American patients with asthma is unclear. The influence of FAO on asthma treatment response in African-American patients with asthma is unclear. MethodsThis 12-week, randomized, double-blind study (NCT00702325) was conducted in moderate–severe African-American (self-reported) patients with asthma aged ≥12 years previously receiving medium- to high-dose inhaled corticosteroid (J Asthma.2012;49:70-77). Percentage of patients achieving ≥100mL improvement in FEV1, ≥100mL improvement in FVC, and ≥0 decrease (inhalations/day) in rescue medication use from baseline to randomized treatment period mean (responders) were stratified by FAO category(screening post albuterol forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <0.70[with] or ≥0.70[without]) in the twice-daily BUD/FM pMDI 320/9 μg (n=37[with], n=119[without]) and BUD dry powder inhaler(DPI) 360 μg(n=34[with], n=121[without]) arms after a 2-week run-in on twice-daily BUD DPI 180mg. This 12-week, randomized, double-blind study (NCT00702325) was conducted in moderate–severe African-American (self-reported) patients with asthma aged ≥12 years previously receiving medium- to high-dose inhaled corticosteroid (J Asthma.2012;49:70-77). Percentage of patients achieving ≥100mL improvement in FEV1, ≥100mL improvement in FVC, and ≥0 decrease (inhalations/day) in rescue medication use from baseline to randomized treatment period mean (responders) were stratified by FAO category(screening post albuterol forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <0.70[with] or ≥0.70[without]) in the twice-daily BUD/FM pMDI 320/9 μg (n=37[with], n=119[without]) and BUD dry powder inhaler(DPI) 360 μg(n=34[with], n=121[without]) arms after a 2-week run-in on twice-daily BUD DPI 180mg. ResultsBaseline characteristics suggested a greater degree of impairment in patients with versus without FAO. In the BUD/FM group, the percentages of patients meeting response criteria for FEV1, FVC, and rescue medication use were similar or higher in patients with versus without FAO(62.2% vs 51.3%, 54.1% vs 49.6%, and 70.3% vs 70.6%, respectively). The percentages of FEV1, FVC, and rescue medication use responders in patients with versus without FAO were 29.4% vs 42.1%, 29.4% vs 41.3%, and 61.8% vs 60.3%, respectively, in BUD patients. Baseline characteristics suggested a greater degree of impairment in patients with versus without FAO. In the BUD/FM group, the percentages of patients meeting response criteria for FEV1, FVC, and rescue medication use were similar or higher in patients with versus without FAO(62.2% vs 51.3%, 54.1% vs 49.6%, and 70.3% vs 70.6%, respectively). The percentages of FEV1, FVC, and rescue medication use responders in patients with versus without FAO were 29.4% vs 42.1%, 29.4% vs 41.3%, and 61.8% vs 60.3%, respectively, in BUD patients. ConclusionsIn this African-American population of patients with moderate to severe asthma, a robust response to BUD/FM was observed across multiple control metrics, irrespective of the presence of FAO. A substantially greater percentage of patients with FAO receiving BUD/FM pMDI versus BUD DPI exhibited meaningful improvements in FEV1 and FVC. In this African-American population of patients with moderate to severe asthma, a robust response to BUD/FM was observed across multiple control metrics, irrespective of the presence of FAO. A substantially greater percentage of patients with FAO receiving BUD/FM pMDI versus BUD DPI exhibited meaningful improvements in FEV1 and FVC." @default.
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- W1996884860 title "Effect of Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) in African-American Patients with Moderate to Severe Asthma: Responder Analysis in Patients with Versus without Fixed Airflow Obstruction (FAO)" @default.
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