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Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma.
J Pediatr. 2005 Aug; 147(2):213-20.JPed

Abstract

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 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).

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.

Authors+Show Affiliations

Allergy and Asthma Medical Group and Research Center, A.P.C., San Diego, California 92123, USA. information@allergyandasthma.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16126052

Citation

Ostrom, Nancy K., et al. "Comparative Efficacy and Safety of Low-dose Fluticasone Propionate and Montelukast in Children With Persistent Asthma." The Journal of Pediatrics, vol. 147, no. 2, 2005, pp. 213-20.
Ostrom NK, Decotiis BA, Lincourt WR, et al. Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma. J Pediatr. 2005;147(2):213-20.
Ostrom, N. K., Decotiis, B. A., Lincourt, W. R., Edwards, L. D., Hanson, K. M., Carranza Rosenzweig, J. R., & Crim, C. (2005). Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma. The Journal of Pediatrics, 147(2), 213-20.
Ostrom NK, et al. Comparative Efficacy and Safety of Low-dose Fluticasone Propionate and Montelukast in Children With Persistent Asthma. J Pediatr. 2005;147(2):213-20. PubMed PMID: 16126052.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma. AU - Ostrom,Nancy K, AU - Decotiis,Bruce A, AU - Lincourt,William R, AU - Edwards,Lisa D, AU - Hanson,Kathleen M, AU - Carranza Rosenzweig,Jacqueline R, AU - Crim,Courtney, PY - 2004/09/17/received PY - 2005/01/21/revised PY - 2005/03/29/accepted PY - 2005/8/30/pubmed PY - 2005/9/28/medline PY - 2005/8/30/entrez SP - 213 EP - 20 JF - The Journal of pediatrics JO - J Pediatr VL - 147 IS - 2 N2 - 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 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). 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. SN - 0022-3476 UR - https://www.unboundmedicine.com/medline/citation/16126052/Comparative_efficacy_and_safety_of_low_dose_fluticasone_propionate_and_montelukast_in_children_with_persistent_asthma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(05)00310-0 DB - PRIME DP - Unbound Medicine ER -