Low-dose fluticasone propionate significantly improved pulmonary function, controlled nocturnal symptoms, and reduced the need for supplemental albuterol, compared with montelukast in a study of children with persistent asthma.
Fluticasone was significantly more cost effective than was montelukast and earned higher satisfaction ratings among parents and physicians, reported Nancy K. Ostrom, M.D., of the Allergy and Asthma Medical Group and Research Center, San Diego, and her colleagues.
In clinical practice, either medication can be prescribed as initial controller therapy for patients, according to the investigators (J. Pediatr. 2005;147:213–20). Although adult asthma studies demonstrate safety and efficacy of each drug, comparative data in pediatric patients are limited.
The investigators randomized 172 children to 50 mcg fluticasone propionate administered via the Diskus multidose powder inhaler (GlaxoSmithKline) twice daily and 170 others to 5 mg montelukast (Singulair, Merck) once daily. Participants in the randomized, double-blind study were 6- to 12-year-old outpatients from 43 medical centers.
The study was supported by GlaxoSmithKline, a company from which Dr. Ostrom has received consultant, grant, and research support.
The mean percent increase in forced expiratory volume in one second (FEV1) at 12 weeks in the fluticasone propionate group was 11% versus 5% in the montelukast group, a significant difference.
Also, mean total albuterol supplementation, nighttime albuterol use, and nighttime symptoms scores were significantly lower with fluticasone propionate than with montelukast.
“As a matter of company policy, Merck does not comment on competitor-initiated studies,” spokesperson Carmen L. de Gourville said when contacted for comment.
At 12 weeks, more parents were very satisfied with fluticasone propionate (58%), compared with montelukast (46%). Similarly, more physicians were very satisfied at 12 weeks with fluticasone propionate (48%), versus montelukast (29%).
Headache, upper respiratory tract infection, sore throat, fever, and cough were the most common adverse events. Incidence was similar between groups.