Adherence with montelukast or fluticasone in a long-term clinical trial: Results from the Mild Asthma Montelukast Versus Inhaled Corticosteroid Trial

BackgroundNonadherence with asthma therapy is common and may contribute to poor clinical outcomes.ObjectiveTo examine the effect of dosing frequency and mode of delivery of therapy on adherence and clinical outcomes.MethodsWe examined adherence in patients with mild persistent asthma (15-85 years) enrolled in a randomized study of montelukast (10 mg once daily) or fluticasone (88 μg, 2 puffs twice daily) during a 12-week double-blind treatment period (DB), followed by a 36-week open-label trial (OL). Adherence was monitored using eDEM for montelukast/placebo and MDILog devices for fluticasone/placebo.ResultsParticipants used at least 1 puff of inhaled therapy on 83.3% DB/76.8% OL of days and at least 1 dose of oral therapy on 77.5%/71.4% of days (P < .0001). Subjects used inhaled therapy less than prescribed on 49.5%/57.5% of days, compared with 22.5%/28.6% of days for oral therapy (P < .0001). In the DB, a dose-response relationship was observed with fluticasone and asthma rescue-free days (P = .02) and FEV1 percent predicted (P < .01) only for patients with FEV1 ≤ 86%. In the OL period, a dose-response relationship was observed with fluticasone and FEV1 percent predicted (P < .001).ConclusionWhereas subjects were more likely to use inhaled fluticasone/placebo at least once a day, subjects were more likely to take once-daily oral montelukast/placebo as prescribed. Clinical outcomes were inconsistently associated with adherence levels.Clinical implicationsPatients were less likely to be fully adherent with twice-daily therapy than with once-daily therapy, but most still achieved adequate asthma control.