This post-hoc analysis examined clinical markers of worsening asthma with FSC 100/50 BID versus FP 250 BID in patients who required FP 250 BID for asthma control.
Data from two replicate, double-blind, parallel group, equivalence studies were evaluated. Patients requiring FP 250 BID for asthma stability were randomized to FSC 100/50 or FP 250 BID for 12–24 weeks. For subjects who developed worsening asthma, patient-evaluated morning/evening PEF, albuterol use, and asthma symptom scores were analyzed for 14 days prior to the development of worsening asthma as defined by: ≥20% decrease in FEV1, ≥20% decrease in AM PEF on 3 consecutive days, or an asthma exacerbation.
ParameterWeeks 1–12Weeks 13–24FSC 100/50 BID (n=572)FP 250 BID (n=552)FSC 100/50 BID (n=269)FP 250 BID (n=240)Worsening asthma*35 (6%)53(10%)17(6%)17 (7%) ≥20% decrease in FEV1162066 ≥20% decrease in AM PEF61755 Asthma141564 Exacerbation Investigator21212 Discretion*
Patients may have met more than one criterion for worsening asthma.Fewer FSC vs FP patients developed worsening asthma and no patient in either group developed an exacerbation requiring hospitalization. The percentage of patients withdrawn due to worsening asthma based on FEV1 or AM PEF were comparable in both groups over the study period (63–65% in each group). The pattern of changes in PEF, albuterol use, and asthma symptoms was similar.CONCLUSIONS: Among patients requiring FP 250 BID for asthma stability, FSC was ICS-sparing allowing a 60% reduction in ICS dose while reducing the overall incidence of worsening asthma. The pattern of worsening asthma did not differ in patients treated with FSC versus higher dose FP alone.
Though fewer FSC patients developed worsening asthma, the pattern of decline in clinical parameters preceding an exacerbation was similar for both groups, suggesting that both clinicians and patients can follow a standard action plan for detecting and treating exacerbations.
P.M. Dorinsky, I am an employee of GSK, Industry.