Abstract

SLS evaluated the effectiveness and safety of asthma medications in everyday clinical practice (Woodcock A et al. BMC Pulm Med 2015;15:160). Symptomatic patients (pts), on ICS (± LABA) initiated treatment with FF/VI (100/25, 200/25 µg od) or continued optimised UC for 52 wks. Electronic health records were used to collect data; clinic visits at start/end with phone calls wks 12, 24, 40. Primary endpoint for asthma control: % pts with asthma control test (ACT) ≥ 20 and/or increase of ≥ 3 at wk 24 for the primary effectiveness analysis (PEA) population (ITT pts with an ACT A total of 3,026 and 4,233 pts comprised the PEA and ITT, respectively. Mean age 49.8 yrs, 87% asthma ≥ 5 yrs, 36% on ICS, 64% ICS/LABA (ITT). At wk24, significantly greater % pts improved or achieved asthma control with initiating FF/VI (71%) vs. continuing on UC (56%); adjusted odds ratio 2.00 [95% CI 1.70,2.34]; p There were 42 pneumonia events: 24 in 23 pts (FF/VI) and 18 in 16 pts (UC) by randomised treatment arm; this corresponded to 21 in 20 pts (FF/VI) and 21 in 19 pts (UC) by treatment at time of pneumonia. There were 284 (13%) SAEs of similar types per arm. Initiating treatment with FF/VI demonstrated improved asthma control compared with continuing UC in everyday clinical practice.

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