title: 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.
authors.affiliation: Buenos Aires Children's Hospital Ricardo Gutierrez, University of Buenos Aires, Buenos Aires, Argentina. maspero@ciudad.com.ar
authors.forename: J F
authors.initials: JF
authors.lastname: Maspero
authors.forename: E
authors.initials: E
authors.lastname: Dueñas-Meza
authors.forename: B
authors.initials: B
authors.lastname: Volovitz
authors.forename: C
authors.initials: C
authors.lastname: Pinacho Daza
authors.forename: L
authors.initials: L
authors.lastname: Kosa
authors.forename: F
authors.initials: F
authors.lastname: Vrijens
authors.forename: J A
authors.initials: JA
authors.lastname: Leff
mesh_terms: D000085:Acetates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D018592:Cross-Over Studies; D003521:Cyclopropanes; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006295:Health Resources / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D010349:Patient Compliance; D017060:Patient Satisfaction; D011804:Quinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013440:Sulfides; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D001507:Beclomethasone; C093875:montelukast