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.

Primary Adherence to Controller Medications for Asthma Is Poor

“…Our finding that adherence to LTRAs and ICS/LABAs is better than adherence to ICSs is supported by previous studies. A study by Maspero and colleagues found that adherence to montelukast, an LTRA that is administered orally, is greater than to inhaled beclomethasone, an ICS, and children and parents reported that montelukast was more convenient and less difficult to use (25). Another study that examined prescription refills found that adherence to montelukast was significantly greater than to an ICS (26).…”

The Cochrane Library and Leukotriene Receptor Antagonists for Children with Asthma: An Overview of Reviews

“…Three of the four studies scored 5 out of a possible 5 points on the Jadad scale (31)(32)(33), indicating appropriate randomisation and double-blinding techniques and documentation of losses and withdrawals. The fourth study scored 3 out of 5, as blinding methods were not employed (34). Two studies reported adequate methods for allocation concealment (32,33), the third study's methods were not described (31) and concealment of allocation was not used in the fourth study (34).…”

Adherence: Its Role in Achieving Control Over Bronchial Asthma in Children

“…Так, в многоцентровом открытом 6-месячном наблюдении [21] по изучению эффективности, безопасности и удовлетворенности терапией монтелукастом в сравнении с ингаляционным глюкокортикостероидом беклометазоном приняли уча-стие 124 ребенка в возрасте 6-11 лет с бронхиальной астмой. Показатели общей эффективности и безопас-ности были сходными и не имели достоверных различий.…”