Methods: Data from 2 phase III studies investigating the effects of MF/F 200/10μg (study P04334) and MF/F 400/10μg (study P04431) were included. All subjects were ≥12y and not well controlled on medium dose (P04334) or high-dose (P04431) inhaled corticosteroid (ICS). After 2-3wks of run-in on twice-daily (BID) MF 200μg (P04334) or 400μg (P04431), subjects were randomized to 26wks of BID MF/F 200/10μg, MF 200μg, F 10μg, or placebo (PBO) in P04334; or 12wks of BID MF/F 200/10μg, MF/F 400/10μg, or MF 400μg in P04431. The Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ[S]), consisting of 4 domains (Symptoms, Activity Limitation, Emotional Function, and Environmental Stimuli), was used to assess QoL. AQLQ(S) score changes from baseline were assessed; a difference ≥0.5 was considered clinically meaningful. Study protocols were approved by IRBs; written informed consent was provided by all subjects or a parent/guardian.
Results: In P04334 (n=781), subjects receiving MF/F 200/10μg experienced significant improvements in total score (13.1%) and the 4 domain scores of the AQLQ(S) at endpoint vs those receiving PBO (P≤.005) or F 10μg (P≤.024). Clinically meaningful improvements in total AQLQ(S) from baseline to wk26 were observed in patients receiving MF/F 200/10μg (0.61). In P04431 (n=728), subjects receiving MF/F 200/10μg experienced significant improvements in total score (12.8%) and the Symptoms and Activity Limitation domain scores of the AQLQ(S) at endpoint vs those who received MF 400μg (P≤.017). Clinically meaningful improvements in total AQLQ(S) from baseline to wk12 occurred in patients receiving MF/F 200/10μg (0.61), MF/F 400/10μg (0.51), or MF 400μg (0.5).
Conclusions: Patients with persistent asthma receiving MF/F had statistically significant, clinically meaningful improvements in QoL in 2 phase III studies. These data suggest that MF/F combination therapy improves the health-related QoL of patients with persistent asthma who are inadequately controlled on medium- or high-dose ICS.