Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma.
OBJECTIVE
To evaluate efficacy, safety, health outcomes, and cost-effectiveness of fluticasone propionate (FP) versus montelukast (MON) in 342 children (6 to 12 years of age) with persistent asthma.


METHODS
Randomized, double-blind, 12-week study of treatment with FP inhalation powder 50 mug twice daily or MON chewable 5 mg once daily for 12 weeks.


RESULTS
Compared with MON, FP significantly increased mean percent change from baseline FEV1 (forced expiratory volume in 1 second) (P=.002), morning PEF (peak expiratory flow) (P=.004), evening PEF (P=.020), and percent rescue-free days (P=.002) at end point, and it significantly reduced nighttime symptom scores (P <.001) and mean total (P=.018), and nighttime (P <.001) albuterol use. Withdrawals from the study were more frequent with MON (21%) than with FP (13%). Adverse events (69% vs 71%) and mean end point to baseline 12-hour urinary cortisol excretion ratios were similar. Parents and physicians were more satisfied with FP treatment than with MON (P=.006 and P=.016, respectively, at Week 12). Mean total daily asthma-related cost per patient in the FP group was approximately one-third of that in the MON group ($1.25 vs $3.49).


CONCLUSIONS
FP was significantly more effective than MON in improving pulmonary function, asthma symptoms, and rescue albuterol use. Both therapies had similar safety profiles. Parent- and physician-reported satisfaction ratings were higher with FP treatment, and asthma-related costs were lower.
Ostrom
Nancy K
NK
Allergy and Asthma Medical Group and Research Center, A.P.C., San Diego, California 92123, USA. information@allergyandasthma.com
Decotiis
Bruce A
BA
Lincourt
William R
WR
Edwards
Lisa D
LD
Hanson
Kathleen M
KM
Carranza Rosenzweig
Jacqueline R
JR
Crim
Courtney
C
D000085:Acetates / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000730:Androstadienes / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D001249:Asthma / Q000145:classification / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D002648:Child; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D008297:Male; D011804:Quinolines / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D000068298:Fluticasone; C093875:montelukast; D006854:Hydrocortisone