Original Article
Comparative Efficacy and Safety of Low-dose Fluticasone Propionate and Montelukast in Children with Persistent Asthma

https://doi.org/10.1016/j.jpeds.2005.03.052Get rights and content

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.

Study design

Randomized, double-blind, 12-week study of treatment with FP inhalation powder 50 μg 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).

Conclusion

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.

Section snippets

Patients

Children 6 to 12 years of age were enrolled in the study if they had at least a 6-month history of chronic asthma, as defined by the American Thoracic Society,25 and required the use of short-acting β2-agonist bronchodilators over the 3 months immediately before the study. Patients were required to have a baseline FEV1 (forced expiratory volume in 1 second) of 60% to 85% of predicted values,26 with an adjustment for African-Americans.27 To confirm the diagnosis of asthma, patients had to

Disposition and Demographics

Patients were recruited for the study from September 2000 until July 2002. Baseline demographics, asthma history, and pulmonary function of 342 pediatric patients who met entry criteria and were randomized to treatment with either 50 μg FP twice daily (n = 172) or MON 5 mg once daily (n = 170), were not significantly different (Table I). During the treatment period, five patients (3%) in the FP group received rescue oral corticosteroids compared with seven (4%) in the MON group. The mean study drug

Discussion

The choice of an appropriate, long-term therapeutic agent is a key step in controlling symptoms, improving pulmonary function, and attempting to alter the natural progression of childhood asthma. Recommendations in the NHLBI and American Academy of Pediatrics guidelines for the use of inhaled corticosteroids as the preferred treatment for managing persistent asthma in children are supported by extensive evidence-based research. Alternative treatments include cromolyn, leukotriene modifiers,

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    Supported by a grant from GlaxoSmithKline Inc., Research Triangle Park, North Carolina.

    Disclaimer: Dr Ostrom has received consultant/grant/research support from the following companies: Abbott, AstraZeneca, Aventis, Merck, Bristol-Myers Squibb, Eli Lilly, Fisons, Forest, GlaxoSmithKline, Hoffmann-LaRoche, McNeil Consumer Products, Mead Johnson, Muro, Novartis, Parke-Davis, Pfizer, Rhone-Poulenc Rorer, Sandoz, Schering-Plough, Sepracor, Synergen, 3M Pharmaceuticals, and Wallace and Warner Lambert. William R. Lincourt, Dr Lisa D. Edwards, Kathleen M. Hanson, Dr Jacqueline R. Carranza Rosenzweig, and Dr Courtney Crim are employees of GlaxoSmithKline, Inc.

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