Oral Montelukast Versus Inhaled Beclomethasone in 6- to 11-year-old Children with Asthma: Results of an Open-label Extension Study Evaluating Long-term Safety, Satisfaction, and Adherence with Therapy

Abstract

This 6-month, open-label extension study of a previously described base study compared oral montelukast with inhaled beclomethasone in terms of safety, forced expiratory volume in one second (FEV1) measurements, parent and patient satisfaction with treatment, asthma-related medical resource utilization, school absenteeism, and parental work loss in children with asthma. A total of 124 of 266 asthmatic children, 6 to 11 years of age, who enrolled in the base study entered a 6-month open-label extension study (74 boys, 50 girls) and were re-randomized (2:1 ratio) to receive once-daily oral montelukast (n = 83) or inhaled beclomethasone 100 mcg three times daily (n = 41). Children were evaluated in the clinic prior to re-randomization (Month 0) and at regular visits at 1, 3, and 6 months. Children and their parents showed a significantly higher overall satisfaction for montelukast at 6 months than for inhaled beclomethasone (p = 0.001 and p < 0.05, respectively). According to parents, montelukast was more convenient (p < 0.001), less difficult to use (p = 0.005), and was used as instructed more of the time (p = 0.006) compared with beclomethasone. Oral corticosteroid use was similar in the montelukast (13% of patients) and beclomethasone (17%) treatment groups. The montelukast treatment group was more adherent with their regimen than the inhaled beclomethasone treatment group; almost twice as many children on montelukast compared with inhaled beclomethasone were highly compliant (82% versus 45%). The two study groups were similar with respect to overall safety, change in FEV1, asthma-related medical resource utilization, school absenteeism, and parental work loss. Montelukast represents a safe and effective asthma treatment regimen to which children with asthma are more likely to adhere.

Asthma-Related Health Care Resource Use Among Patients Starting Fluticasone or Montelukast Therapy

“…montelukast experienced similar clinical outcomes, including changes in forced expiratory volume in 1 second and decreases in airway obstruction, asthma symptom scores, and asthma-related health care resource use. 22,23 Although contrary to findings of clinical trials reporting superior efficacy of fluticasone over montelukast under tightly controlled conditions, our results more accurately represent patients' experience in clinical practice. Our results confirmed much of the existing body of observational studies on resource use indicating that significant differences are not seen in patient outcomes with fluticasone or montelukast therapy.…”

“…Open-label extension studies comparing the impact of asthma treatments suggest that longterm asthma outcomes are similar among these treatment groups. 22,23 Results of observational studies involving patients with asthma have shown similar improvements in hospitalizations and emergency department visits among patients prescribed fluticasone and montelukast and have yielded varied results regarding need for rescue drug therapy. [5][6][7][8][9][10]24 The purpose of our study was to reexamine the relative effectiveness of fluticasone and montelukast on asthma-related resource-use patterns based on more recent health care claims data believed to reflect current treatment patterns and outcomes for asthma.…”

A comparison of medication adherence/persistence for asthma and chronic obstructive pulmonary disease in the United Kingdom

“…Medication adherence is known to decrease as dosing frequency increases (37), and all other therapies in the present analysis have a standard twice-daily dosing regimen. TP was the only oral maintenance therapy assessed in the present analysis, and despite a relatively smaller number of patients, the preference for oral therapy was evident for both adherence and persistence, an effect that has been seen previously in children with asthma (38,39). Therapy with an ICS had the lowest percentage of patients (with either disease) identified as having an adequate level of medication supply (MPR 80-120%), but was also found to have a comparatively high rate of adherence/persistence in the regression analyses.…”

Adherence to montelukast versus inhaled corticosteroids in children with asthma

“…6 In a 6-month open-label study of 124 children, Maspero et al noted better adherence to montelukast taken once daily than to inhaled beclomethasone prescribed three times per day. 7 Sherman et al 8 used pharmacy refill data to determine adherence to montelukast vs. fluticasone in 161 children. These investigators found subobtimal adherence to both, but patients taking fluticasone were more likely to have very poor adherence, defined as taking less than 50% of their prescribed dose.…”