Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler: a randomized open-label study

Abstract

Background: Poor adherence with prescribed asthma medication is a major barrier to positive treatment outcomes. This study was designed to determine the effect of a once-daily administration of mometasone furoate administered via a dry powder inhaler (MF-DPI) on treatment adherence compared with a twice-daily administration.

Methods: This was a 12-week open-label study designed to mimic an actual clinical setting in patients >or=12 years old with mild-to-moderate persistent asthma. Patients were randomized to receive MF-DPI 400 microg once-daily in the evening or MF-DPI 200 microg twice-daily. Adherence was assessed primarily using the number of actual administered doses reported from the device counter divided by the number of scheduled doses. Self-reports were also used to determine adherence. Health-related quality of life, healthcare resource utilization, and days missed from work or school were also reported.

Results: 1233 patients were randomized. The mean adherence rates, as measured by the automatic dose counter, were significantly better (P < 0.001) with MF-DPI 400 microg once-daily in the evening (93.3%) than with MF-DPI 200 microg twice-daily (89.5%). Mean adherence rates based on self-reports were also significantly better (P < 0.001) with MF-DPI 400 microg QD PM (97.2%) than with MF-DPI 200 microg twice-daily (95.3%). Adherence rates were lower in adolescents (12-17 years old). Health-related quality of life improved by 20% in patients using MF-DPI once-daily in the evening and by 14% in patients using MF-DPI twice-daily. Very few (<8%) patients missed work/school.

Conclusion: Mean adherence rates were greater with a once-daily dosing regimen of MF-DPI than with a twice-daily dosing regimen.This trial was completed prior to the ISMJE requirements for trial registration.

Figure 1

Subject Disposition. MF-DPI = mometasone furoate administered via a dry powder inhaler.

Figure 2

Mean adherence to treatment. Adherence was calculated as administered doses divided by scheduled doses × 100, as measured by dose counter and patient self-report. Error bars represent standard error of the mean. *P < 0.001. BID = twice-daily; MF-DPI = mometasone furoate administered via a dry powder inhaler; QD = once-daily.

Figure 3

Physician's evaluation of therapeutic response. Response expressed as mean relative to baseline. P = not significant. MF-DPI = mometasone furoate administered via a dry powder inhaler.

Figure 4

Mean percent change in HRQOL. Changes from baseline in HRQOL were measured by ITG-ASF scores in subjects ≥16 years of age. HRQOL = health-related quality of life; ITG-ASF = Integrated Therapeutics Group-Asthma Short Form; MF-DPI = mometasone furoate administered via a dry powder inhaler; QD = once-daily.