Adherence with montelukast or fluticasone in a long-term clinical trial: results from the mild asthma montelukast versus inhaled corticosteroid trial.
BACKGROUND
Nonadherence with asthma therapy is common and may contribute to poor clinical outcomes.


OBJECTIVE
To examine the effect of dosing frequency and mode of delivery of therapy on adherence and clinical outcomes.


METHODS
We 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 microg, 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.


RESULTS
Participants 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 FEV(1) percent predicted (P < .01) only for patients with FEV(1) < or = 86%. In the OL period, a dose-response relationship was observed with fluticasone and FEV(1) percent predicted (P < .001).


CONCLUSIONS
Whereas 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.


CONCLUSIONS
Patients were less likely to be fully adherent with twice-daily therapy than with once-daily therapy, but most still achieved adequate asthma control.
Rand
Cynthia
C
Johns Hopkins School of Medicine, Baltimore, MD 21224, USA. crand@mail.jhmi.edu
Bilderback
Andrew
A
Schiller
Kathleen
K
Edelman
Jonathan M
JM
Hustad
Carolyn M
CM
Zeiger
Robert S
RS
D000085:Acetates / Q000008:administration & dosage* / Q000627:therapeutic use; D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage* / Q000627:therapeutic use; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D003521:Cyclopropanes; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011804:Quinolines / Q000008:administration & dosage* / Q000627:therapeutic use; D013440:Sulfides
D000085:Acetates; D000730:Androstadienes; D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D000068298:Fluticasone; C093875:montelukast