Small-particle Inhaled Corticosteroid as First-line or Step-up Controller Therapy in Childhood Asthma

Article in Press

Willem M.C. van Aalderen, MD, PhD

,

 Jonathan Grigg, MD

,

 Theresa W. Guilbert, MD, MS

,

 Nicolas Roche, MD, PhD

,

Elliot Israel, MD

,

 Richard J. Martin, MD

,

 Gene Colice, MD

,

 Dirkje S. Postma, MD, PhD

,

 Elizabeth V. Hillyer, DVM

,

 Anne Burden, MSc

,

 Victoria Thomas, MSc

,

 Julie von Ziegenweidt

,

 David Price, FRCGP

Publication stage: In Press Corrected Proof

Open Access

DOI: http://dx.doi.org/10.1016/j.jaip.2015.04.012

Open access funded by the Author(s)

Article Info

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Background

Because randomized controlled trials of established pediatric asthma therapies are expensive and difficult to perform, observational studies may fill gaps in the evidence base.

Objectives

To compare the effectiveness of representative small-particle inhaled corticosteroid (ICS) with that of standard size–particle ICS for children initiating or stepping up ICS therapy for asthma (analysis 1) and to compare the effectiveness of ICS dose step-up using small-particle ICS with adding long-acting β2-agonist (LABA) to the ICS (analysis 2).

Methods

These historical matched cohort analyses drew on electronic medical records of children with asthma aged 5 to 11 years. Variables measured during 2 consecutive years (1 baseline year for confounder definition and 1 outcome year) included risk-domain asthma control (no hospital attendance for asthma, acute oral corticosteroids, or lower respiratory tract infection requiring antibiotics) and rate of severe exacerbations (asthma-related emergency, hospitalization, or oral corticosteroids).

Results

In the initiation population (n = 797 in each cohort), children prescribed small-particle ICS versus standard size–particle ICS experienced greater odds of asthma control (adjusted odds ratio, 1.49; 95% CI, 1.10-2.02) and lower severe exacerbation rate (adjusted rate ratio, 0.56; 95% CI, 0.35-0.88). Step-up outcomes (n = 206 in each cohort) were also significantly better for small-particle ICS, with asthma control adjusted odds ratio of 2.22 (95% CI, 1.23-4.03) and exacerbations adjusted rate ratio of 0.49 (95% CI, 0.27-0.89). The number needed to treat with small-particle ICS to achieve 1 additional child with asthma control was 17 (95% CI, 9-107) for the initiation population and 5 (95% CI, 3-78) for the step-up population. Outcomes were not significantly different for stepped-up small-particle ICS dose versus ICS/LABA combination (n = 185 in each cohort).

Conclusions

Initiating or stepping up the ICS dose with small-particle ICS rather than with standard size–particle ICS is more effective and shows similar effectiveness to add-on LABA in childhood asthma.

Key words:

Asthma, Childhood, Small-particle beclomethasone, Fluticasone, Inhaled corticosteroid, Long-acting β2-agonist, Step-up therapy

Abbreviations used:

adjOR (adjusted odds ratio), adjRR (adjusted rate ratio), GP (general practice), ICS (inhaled corticosteroid), LABA (long-acting β2-agonist), NNT (number needed to treat), pMDI (pressurized metered-dose inhaler), RCT (randomized controlled trial), SABA (short-acting β2-agonist)