The Open Respiratory Medicine Journal

ISSN: 1874-3064 ― Volume 14, 2020

Clinical and Economic Outcomes Associated with Low-Dose Fluticasone Propionate Versus Montelukast in Children with Asthma Aged 4 to 11 Years

Richard H Stanford*, 1, Manan Shah 2, Sham L Chaudhari 2
1 GlaxoSmithKline, Research Triangle Park, North Carolina, USA
2 Xcenda, Palm Harbor, Florida, USA



Inhaled corticosteroids (ICS) are preferred first-line controller agents for adults and adolescents with asthma. There is limited effectiveness data comparing ICS to leukotriene receptor antagonists (LTRA) in children with asthma aged 4 to 11 years.


A retrospective, matched cohort study was conducted using medical and pharmacy claims data. Asthma patients (ICD-9, 493.xx) naïve to any asthma controller therapy, and having ≥1 dispensing of fluticasone propionate 44 mcg (FP44), an ICS, or montelukast any dose (MON), an LTRA, were identified. Drug cohorts were matched (1:2) using propensity scores. Outcomes during follow-up included asthma-related ED visits, composite measure of asthma-related ED/hospital visit, asthma-related costs per month, and monthly rescue medication use. Statistical differences between cohorts were evaluated using multivariate regression models.


The final matched sample included 6,636 patients (FP44=2,212; MON=4,424). During follow-up, the FP44 cohort had a 29% significantly lower risk of an asthma-related ED visit (Hazard ratio (95% CI) =0.71 (0.52, 0.96)) compared to the MON cohort. Monthly asthma-related costs were significantly reduced on average by 36% in the FP44 compared to the MON cohort ($48 vs $75, p<0.05). Use of short-acting beta-agonists per month were similar between cohorts but monthly adjusted number of oral corticosteroid prescriptions were significantly lower in the FP44 compared to the MON cohort (0.03 vs 0.04, p<0.001).


Initiation of FP44 versus MON in children with asthma aged 4 to 11 years is associated with a significant reduction in asthma-related ED visits, costs, and oral corticosteroid use.

Keywords: Asthma, pediatrics, inhaled corticosteroids, leukotriene, receptor antagonists, outcomes, costs..

Article Information

Identifiers and Pagination:

Year: 2012
Volume: 6
First Page: 37
Last Page: 43
Publisher Id: TORMJ-6-37
DOI: 10.2174/1874306401206010037

Article History:

Received Date: 14/3/2012
Revision Received Date: 23/5/2012
Acceptance Date: 30/5/2012
Electronic publication date: 21/6/2012
Collection year: 2012

© Stanford et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the Five Moore Drive, Research Triangle Park, NC 27709, USA; Tel: 919 483 3779; Fax: 919-315-5042; E-mail:

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