Prior Inhaled Corticosteroids Research Articles

A Retrospective Study Evaluating Asthma Control in Patients on Fluticasone Propionate/Salmeterol Proactive Regular Dosing with a History of Uncontrolled Asthma.

The MERIT study in Malaysia is a real-world retrospective, observational, multicenter study that evaluated asthma control in patients with uncontrolled asthma who were switched from as-needed (pro re nata [PRN]) budesonide/formoterol or inhaled corticosteroid (ICS) whenever a short-acting beta-agonist (SABA) was taken, to proactive regular dosing of fluticasone propionate/salmeterol (FP/SAL PRD). Data from the medical records of patients who were stepped up to FP/SAL PRD were extracted retrospectively at baseline and follow-up (between 3 and 6months after stepping up to FP/SAL PRD). The primary endpoint was the percentage of patients with improvement in asthma control assessed via the Asthma Control Test (ACT). Secondary endpoints included safety and the percentage of patients with moderate and severe exacerbations. Additionally, patient-reported use of reliever medication, systemic corticosteroids, emergency department visits, or hospitalization was also analyzed. One hundred twenty patients with uncontrolled asthma who were stepped up to FP/SAL PRD were enrolled in the study. Of these, 76 (63.3%) patients were on prior budesonide/formoterol PRN, and 44 (36.7%) were on prior ICS with SABA PRN treatment. After stepping up to FP/SAL PRD with a mean follow-up of 5.8months, 110 (91.7%) patients achieved asthma control at the follow-up visit (p < 0.001). Similar improvements were observed regardless of prior PRN regimen. A statistically significant improvement was observed in the mean ACT score at the follow-up visit (p < 0.0001). The proportion of patients with moderate and severe exacerbations was also reduced after stepping up to FP/SAL PRD, with no adverse events reported. Over 80% of patients reported a decrease in the use of systemic corticosteroids, visits to the emergency department, or hospitalization. This study highlights the effectiveness of the FP/SAL PRD treatment approach in patients with uncontrolled asthma on a PRN treatment regimen.

Factors Associated with Inhaled Bronchodilator and Oral Corticosteroid Use in Young Children with First Lower Respiratory Tract Infection

ObjectivesTo examine factors associated with claims for and potential overuse of inhaled bronchodilators (IB) and oral corticosteroids (OCS) for children < 2 years old at first lower respiratory tract infections (LRTI) . Study designRetrospective cohort study using Colorado All Payer Claims data from 2009 through 2019. Children with asthma were excluded. Primary outcomes were 1) IB and 2) OCS claims within 7 days of index LRTI. Primary predictors were previous IB or OCS claims for each outcome respectively. Covariates included demographics, atopy, family history of asthma, complex chronic conditions (CCC), prior inhaled corticosteroid (ICS) claim, and location of index LRTI. Separate multivariable logistic regression models were used for each outcome. ResultsOf 10,194 eligible children, 1468 (14.4%) had an IB and 741 (7.3%) an OCS claim at or within 7 days of index LRTI. Index LRTIs were most often at outpatient (OP) visits (64%). Adjusting for covariates, prior IB prescription was associated with the IB outcome (AOR 1.9; 95% CI 1.3, 2.8), and prior OCS prescription was associated with the OCS outcome (AOR 2.2; 95% CI (1.7, 2.9). Other variables associated with either outcome included age, sex, insurance, location, and atopy. Prior ICS claim, asthma family history, and CCC were not associated with either outcome. ConclusionsThis study identifies factors that might serve as opportunities for de-implementation strategies for IB and OCS overuse in young children with LRTI.

The influence of prior use of inhaled corticosteroids on COVID-19 outcomes: A systematic review and meta-analysis.

The influence of inhaled corticosteroids (ICS) on COVID-19 outcomes remains uncertain. To address this, we conducted a systematic review and meta-analysis, analyzing 30 studies, to investigate the impact of ICS on patients with COVID-19. Our study focused on various outcomes, including mortality risk, hospitalization, admission to the intensive care unit (ICU), mechanical ventilation (MV) utilization, and length of hospital stay. Additionally, we conducted a subgroup analysis to assess the effect of ICS on patients with chronic obstructive pulmonary disease (COPD) and asthma. Our findings suggest that the prior use of ICS did not lead to significant differences in mortality risk, ICU admission, hospitalization, or MV utilization between individuals who had used ICS previously and those who had not. However, in the subgroup analysis of patients with COPD, prior ICS use was associated with a lower risk of mortality compared to non-users (OR, 0.95; 95% CI, 0.90-1.00). Overall, while the use of ICS did not significantly affect COVID-19 outcomes in general, it may have beneficial effects specifically for patients with COPD. Nevertheless, more research is needed to establish a definitive conclusion on the role of ICS in COVID-19 treatment. PROSPERO registration number: CRD42021279429.

Relationship between prior inhaled corticosteroid use and benefits of budesonide/glycopyrronium/formoterol fumarate dihydrate on exacerbations, symptoms, health-related quality of life, and lung function in patients with chronic obstructive pulmonary disease: Analyses from the ETHOS study

BackgroundIn the Phase III ETHOS study (NCT02465567), budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) triple therapy at two inhaled corticosteroid (ICS) doses reduced moderate/severe exacerbation rates and improved symptoms, health-related quality of life (HRQoL), and lung function versus glycopyrronium/formoterol fumarate dihydrate (GFF) or budesonide/formoterol fumarate dihydrate (BFF) dual therapy in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). Here, we assessed whether the benefit for BGF versus GFF was driven by patients who received ICS before randomization to GFF. MethodsETHOS was a 52-week, randomized, double-blind, multicenter, parallel-group study in symptomatic patients with COPD and ≥1 moderate/severe exacerbation in the previous year. Patients received BGF 320/14.4/10 μg, BGF 160/14.4/10 μg, GFF 14.4/10 μg, or BFF 320/10 μg twice daily via a single metered dose Aerosphere™ inhaler. In these subgroup analyses, efficacy and safety were assessed in patients with or without prior ICS use in the 30 days before screening. ResultsThe modified intent-to-treat population comprised 8509 patients (prior ICS use, n = 6810 [80%]; no prior ICS use, n = 1699 [20%]). Moderate/severe exacerbation rates were reduced by 24% and 23% in patients with and without prior ICS use, respectively, with BGF 320 versus GFF. Benefits of BGF 320 versus GFF were also similar in patients with and without prior ICS use across other endpoints relating to exacerbations, symptoms, HRQoL, lung function, and safety. Trends were similar for BGF 160 versus GFF. ConclusionBenefits on exacerbations, symptoms, HRQoL, and lung function with BGF versus GFF were observed, irrespective of prior ICS use in the 30 days before screening.

Inhaled Corticosteroids and COVID-19 Risk and Mortality: A Nationwide Cohort Study.

Inhaled corticosteroids (ICS) could increase both the risk of coronavirus disease 2019 (COVID-19) and experiencing poor outcomes. To compare the clinical outcomes between ICS users and nonusers, COVID-19-related claims in the Korean Health Insurance Review and Assessment database were evaluated. To evaluate susceptibility to COVID-19 among patients with COPD or asthma, a nested case-control study was performed using the same database. In total, 7341 patients were confirmed to have COVID-19, including 114 ICS users and 7227 nonusers. Among 5910 patients who were hospitalized, death was observed for 9% of ICS users and 4% of nonusers. However, this association was not significant when adjusted for age, sex, region, comorbidities, and hospital type (aOR, 0.94; 95% CI, 0.43–2.07). The case-control analysis of COPD compared 640 cases with COVID-19 to 2560 matched controls without COVID-19, and the analysis of asthma compared 90 cases with COVID-19 to 360 matched controls without COVID-19. Use of ICS was not significantly associated with COVID-19 among patients with COPD (aOR, 1.02; 95% CI, 0.46–2.25) or asthma (aOR, 0.38; 95% CI, 0.13–1.17). Prior ICS use was not significantly associated with COVID-19 in patients with COPD or asthma, nor with clinical outcomes among patients with COVID-19.

Inhaled corticosteroids prescriptions increased in the ED for recurrent asthma exacerbations by automated electronic reminders in the ED

Objective: The objective of this study was to evaluate the impact of an electronic alert on the prescription rate of inhaled corticosteroids (ICS) by ED providers for poorly controlled persistent asthmatic children.Methods: Study subjects included asthmatic patients age 4–18 presenting to the ED at Phenix Children’s Hospital between February 9, 2018 and December 4, 2018, with a history of at least two previous ED visits for acute exacerbation of asthma within 365 days, no active ICS prescription within 90 days, and free from developmental delay, bronchopulmonary dysplasia due to prematurity, cystic fibrosis, sickle cell disease, and/or interstitial ling disease. Patients meeting these criteria triggered an electronic alert prompting the medical provider to prescribe ICS or indicate reason for not prescribing. Instruction on the alert was provided to ED attending physicians and residents by email and through several educational sessions held prior to the implementation.Results: Among 62 patients without prior ICS who were discharged home from the ED, ICS was prescribed for 48 (77%). No statistically significant differences were detected in baseline characteristics between patients discharged home from the ED with and without ICS prescription. While ICS was prescribed by a larger proportion of physicians (56%) compared to residents (42%), statistical significance was not reached. For the 14 (33%) patients who were discharged home without ICS, no reason was provided to indicate why ICS were not prescribed.Conclusion: An electronic alert incorporated into the ED workflow to populate a discharge order set is effective to initiate asthma controller medication for poorly controlled pediatric patients. Additional data describing reasons for not prescribing ICS can further refine recommendations for ICS prescriptions, and provide a comprehensive strategy to support clinical decision for pediatric asthma control in acute care settings.

Identification of factors associated with exacerbation risk in severe COPD: multivariate analysis of the WISDOM study

Introduction: Treatment management and patient outcomes could be improved by identifying patients with severe COPD who are at increased risk of exacerbations. Aim: To identify factors associated with exacerbation risk using a multivariate analysis of data from the WISDOM study. Methods: In WISDOM (NCT00975195; 12-month, randomised, parallel-group study), patients with severe to very severe COPD and a history of exacerbations received 18 µg tiotropium, 100 µg salmeterol and 1000 µg fluticasone propionate daily for 6 weeks, then continued or reduced inhaled corticosteroids (ICS) for 12 weeks. This post hoc multivariate analysis of time to first moderate or severe exacerbation used a stepwise selection process for candidate variables. Results: For the overall study period, the analysis was based on 2291 patients. Factors associated with a significantly increased risk of exacerbation were taking ICS at screening and ≥2 previous courses of antibiotics or steroids (Figure). Higher baseline FEV 1 , GOLD C vs GOLD D and taking xanthines at screening were associated with a significantly decreased risk of exacerbation. A backwards elimination variable selection process confirmed these results. Conclusions: Several factors were significantly associated with exacerbation risk in WISDOM. An increased risk was found in patients with prior ICS treatment and an exacerbation history. Funding: Boehringer Ingelheim.

Real-life use of fluticasone propionate/salmeterol in patients with chronic obstructive pulmonary disease: a French observational study.

BackgroundIn Europe, administration of an inhaled corticosteroid (ICS) combined with a long-acting β2 agonist is approved in chronic obstructive pulmonary disease (COPD) patients with a pre-bronchodilator FEV1 < 60% predicted normal, a history of repeated exacerbations, and who have significant symptoms despite regular bronchodilator therapy. Minimal data are available on the use of the fluticasone propionate/salmeterol xinafoate combination (FSC) in the real-life COPD setting and prescription compliance with the licensed specifications.MethodsA French observational study was performed to describe the COPD population prescribed with FSC, prescription modalities, and the coherence of prescription practices with the market authorized population. Data were collected for patients initiating FSC treatment (500 μg fluticasone propionate, 50 μg salmeterol, dry powder inhaler) prescribed by a general practitioner (GP) or a pulmonologist, using physician and patient questionnaires.ResultsA total of 710 patients were included, 352 by GPs and 358 by pulmonologists. Mean age was over 60 years, and 70% of patients were male. More than half were retired, and overweight or obese. Approximately half were current smokers and one-third had cardiovascular comorbidities. According to both physician evaluation and GOLD 2006 classification, the majority of patients (>75%) had moderate to very severe COPD. Strict compliance by prescribing physicians with the market-approved population for dry powder inhaler SFC in COPD was low, notably in ICS-naïve patients; all three conditions were fulfilled in less than a quarter of patients with prior ICS and less than 7% of ICS-naïve patients.ConclusionsPrescription of dry powder inhaler SFC by GPs and pulmonologists has very low conformity with the three conditions defining the licensed COPD population. Prescription practices need to be improved and systematic FEV1 evaluation for COPD diagnosis and treatment management should be emphasized.

Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD

This post-hoc analysis examined the impact of roflumilast on chronic obstructive pulmonary disease (COPD) exacerbations and lung function in patients with COPD who received concomitant long-acting β2-agonists (LABA) with or without prior inhaled corticosteroid (ICS) and the influence of various demographic and clinical characteristics on these outcomes. Data were pooled from 2 double-blind, placebo-controlled, 52-week studies of once-daily roflumilast 500μg in patients with COPD. Endpoints were mean rate of exacerbations and change from baseline in pre- and postbronchodilator FEV1. In this pooled analysis (N=3091), addition of roflumilast to LABAs for 1 year in patients who discontinued ICS prior to study entry (n=945) significantly reduced the risk of COPD exacerbations vs. placebo by 19.2% (p<0.05) and significantly improved pre- and postbronchodilator FEV1 by 40mL and 34mL, respectively (both, p<0.01). Similar improvements were observed in patients who received concomitant LABAs but were not taking ICS prior to study entry (n=597). A significant reduction in COPD exacerbation risk with roflumilast vs. placebo was observed regardless of age or smoking status, and in patients who had severe or very severe COPD. Significantly improved lung function was observed with roflumilast in all the subgroups (p<0.05), with the exception of patients with moderate COPD. Roflumilast reduced exacerbation rates and improved lung function in patients with COPD who received concomitant LABA, regardless of prior ICS use, and across various patient subgroups regardless of age and smoking status. NCT00297102 (M2-124) and NCT00297115 (M2-125).

Influence of Previous Use of Inhaled Corticoids on the Development of Pleural Effusion in Community-acquired Pneumonia

Previous use of inhaled corticosteroids (ICS) in patients with chronic obstructive pulmonary disease has been associated with increased risk of community-acquired pneumonia. However, ICS have been associated with fewer pneumonia complications and decreased risk of pneumonia-related mortality. The objective of the study was to assess the influence of previous use of ICS on the incidence of parapneumonic effusion in patients with different baseline respiratory disorders. We conducted a single-center cohort study of 3,612 consecutively collected patients diagnosed with community-acquired pneumonia. We assessed clinical, radiographic, and pleural-fluid chemistry and microbiologic variables. Patients were classified according to whether or not they received prior ICS treatment. A total of 633 patients (17%) were treated with corticosteroids before the diagnosis of pneumonia (chronic obstructive pulmonary disease, 54%; asthma, 13%). Incidence of parapneumonic effusion was lower in patients with ICS use compared with non-ICS patients (5% vs. 12%; P < 0.001). After matching according to propensity scores (n = 640), prior treatment with corticosteroids was still significantly associated with a lower incidence of parapneumonic effusion (odds ratio, 0.40; 95% confidence interval, 0.23-0.69; P = 0.001) compared with patients without ICS treatment. Prior ICS treatment was associated with higher levels of glucose (P = 0.003) and pH (P = 0.02), and lower levels of protein (P = 0.01) and lactic acid dehydrogenase (P = 0.007) in the pleural fluid. Prior treatment with ICS in a population of patients with different respiratory chronic disorders who develop pneumonia is associated with lower incidence of parapneumonic effusion.

Chronic obstructive pulmonary disease and mortality from pneumonia: meta-analysis

We aimed to determine whether patients with concomitant community-acquired pneumonia (CAP) and chronic obstructive pulmonary disease (COPD) are at greater risk of death when compared with those with CAP or acute COPD exacerbation alone. We also assessed the effect of inhaled corticosteroids (ICS) on pneumonia mortality in COPD. We searched MEDLINE and EMBASE from inception to March 2012 for studies reporting on mortality in patients with COPD and CAP. We assessed ascertainment of disease, mortality, drug exposure and adjustment for confounders. Data were pooled using random effects meta-analysis, and heterogeneity was estimated using I². We identified 24 eligible articles overall. Evaluation of 13 studies revealed considerable heterogeneity and a non-significant mortality risk associated with concomitant COPD and CAP as compared with CAP in five studies that reported adjusted or severity-matched data, pooled RR 1.44 (95% CI 0.97-2.16, I² = 50%). There was also considerable inconsistency amongst the effect estimates from five studies that reported on the associated mortality with concomitant CAP and COPD as compared with acute COPD exacerbations alone. Evaluation of six datasets found that ICS use in COPD was not consistently associated with lower mortality in CAP. Reports of reduced mortality with prior ICS use stemmed from three studies that enrolled participants from the same healthcare database. Evidence on associated mortality risk with concomitant CAP and COPD (as opposed to CAP alone, or COPD exacerbation alone) is weak and heterogeneous. ICS use was not consistently associated with reduced mortality from pneumonia.

Effects of Inhaled Corticosteroids on Pneumonia Severity and Antimicrobial Resistance

Limited information is available regarding the impact of prior use of inhaled corticosteroids (ICS) in patients subsequently developing community-acquired pneumonia (CAP). We assessed the effects of prior ICS use on severity of illness and microbiology in CAP hospitalized patients. A retrospective cohort study of subjects with CAP (by the International Classification of Diseases, 9th Revision, Clinical Modification) was conducted over a 4-year period at 2 tertiary teaching hospitals. Subjects were considered to be ICS users if they received ICS prior to admission. Primary outcomes were severity of illness and microbiology at admission. Data were abstracted on 664 subjects: 89 prior ICS users (13.4%) and 575 non-users (86.6%). Prior ICS users had higher severity of illness at admission: mean ± SD Pneumonia Severity Index 100.8 ± 31.4 vs 68.8 ± 33.4, P = .001, and CURB-65 (confusion, urea nitrogen, respiratory rate, blood pressure, ≥ 65 years of age) score 1.56 ± 1.02 vs 1.19 ± 1.02, P = .002. Prior ICS use was independently associated with antimicrobial-resistant pathogens: 11.2% vs 5.9%, odds ratio 2.6, 95% CI 1.1-6.1, P = .04. Prior ICS use was associated with higher severity of illness at admission and higher incidence of antimicrobial-resistant pathogens in CAP hospitalized patients.

THE PARADOXICAL EFFECT ON PNEUMONIA OF CHRONIC INHALED CORTICOSTEROIDS.

Community-acquired pneumonia (CAP) is the leading infectious cause of death in developed countries. Several studies have shown that the risk of pneumonia is increased in patients with Chronic Obstructive Pulmonary Disease (COPD) who are receiving chronic inhaled corticosteroids (ICS). The impact of ICS On pneumonia prognosis is controversial. Recent studies have shown that COPD patients with prior ICS use have less mortality after developing CAP as compared with patients with COPD without prior ICS use. This review discusses the association of ICS and the risk of CAP and its association with clinical outcomes in patients with COPD and pneumonia.

Impact of inhaled corticosteroid use on outcome in COPD patients admitted with pneumonia

The aim of this study was to investigate whether inhaled corticosteroid (ICS) use affects outcome in patients with chronic obstructive pulmonary disease (COPD) admitted with community-acquired pneumonia (CAP). This was a prospective, observational study of patients with spirometry-confirmed COPD presenting with a primary diagnosis of CAP in Lothian, UK. Outcome measures were compared between ICS users and non-ICS users. Of 490 patients included in the study, 76.7% were classified as ICS users. ICS users had higher Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage compared with non-ICS users (mean ± sd 3.2 ± 0.8 versus 2.6 ± 0.9; p<0.0001). There were no significant differences in pneumonia severity (mean ± sd Pneumonia Severity Index (PSI) 4.2 ± 0.8 versus 4.3 ± 0.8 (p = 0.3); mean ± sd CURB-65 score 2.1 ± 1.3 versus 2.3 ± 1.3 (p = 0.07)) or markers of systemic inflammation (median C-reactive protein 148 (interquartile range 58-268) mg·L(-1) versus 183 (IQR 85-302) mg·L(-1); p = 0.08) between ICS users and non-ICS users. On multivariable analysis, after adjustment for COPD severity and PSI, ICS use was not independently associated with 30-day mortality (OR 1.71, 95% CI 0.75-3.90; p = 0.2), 6-month mortality (OR 1.62, 95% CI 0.82-3.16; p = 0.2), requirement for mechanical ventilation and/or inotropic support (OR 0.73, 95% CI 0.33-1.62; p = 0.4) or development of complicated pneumonia (OR 0.71, 95% CI 0.25-1.99; p = 0.5). Prior ICS use had no impact on outcome in patients with COPD admitted with CAP.

Inhaled corticosteroid use is associated with lower mortality for subjects with COPD and hospitalised with pneumonia

Recent studies suggest that use of inhaled corticosteroids (ICS) in chronic obstructive pulmonary disease (COPD) may be associated with a higher incidence of pneumonia. However, it is unclear whether COPD subjects on ICS who develop pneumonia have worse outcomes. Therefore, our aim was to examine the association of prior outpatient ICS therapy with mortality in hospitalised COPD subjects with pneumonia. We included subjects ≥64 yrs of age, hospitalised with pneumonia in US Veterans Affairs hospitals, and assessed the association of ICS exposure with mortality for hospitalised COPD subjects with pneumonia in a covariate-adjusted regression model. We identified 6,353 subjects with a diagnosis of pneumonia and prior COPD, of whom 38% were on ICS. Mortality was 9% at 30 days and 16% at 90 days. In regression analyses, outpatient ICS therapy was associated with lower mortality at both 30 days (OR 0.76, 95% CI 0.70-0.83), and 90 days (OR 0.80, 95% CI 0.75-0.86). Outpatient therapy with ICS was associated with a significantly lower 30- and 90-day mortality in hospitalised COPD patients with pneumonia.

The impact of generic-only drug benefits on patients' use of inhaled corticosteroids in a Medicare population with asthma

BackgroundPatients face increasing insurance restrictions on prescription drugs, including generic-only coverage. There are no generic inhaled corticosteroids (ICS), which are a mainstay of asthma therapy, and patients pay the full price for these drugs under generic-only policies. We examined changes in ICS use following the introduction of generic-only coverage in a Medicare Advantage population from 2003–2004.MethodsSubjects were age 65+, with asthma, prior ICS use, and no chronic obstructive pulmonary disorder (n = 1,802). In 2004, 74.0% switched from having a $30 brand-copayment plan to a generic-only coverage plan (restricted coverage); 26% had $15–25 brand copayments in 2003–2004 (unrestricted coverage). Using linear difference-in-difference models, we examined annual changes in ICS use (measured by days-of-supply dispensed). There was a lower-cost ICS available within the study setting and we also examined changes in drug choice (higher- vs. lower-cost ICS). In multivariable models we adjusted for socio-demographic, clinical, and asthma characteristics.ResultsIn 2003 subjects had an average of 188 days of ICS supply. Restricted compared with unrestricted coverage was associated with reductions in ICS use from 2003–2004 (-15.5 days-of-supply, 95% confidence interval (CI): -25.0 to -6.0). Among patients using higher-cost ICS drugs in 2003 (n = 662), more restricted versus unrestricted coverage subjects switched to the lower-cost ICS in 2004 (39.8% vs. 10.3%). Restricted coverage was not associated with decreased ICS use (2003–2004) among patients who switched to the lower-cost ICS (18.7 days-of-supply, CI: -27.5 to 65.0), but was among patients who did not switch (-38.6 days-of-supply, CI: -57.0 to -20.3). In addition, restricted coverage was associated with decreases in ICS use among patients with both higher- and lower-risk asthma (-15.0 days-of-supply, CI: -41.4 to 11.44; and -15.6 days-of-supply, CI: -25.8 to -5.3, respectively).ConclusionIn this elderly population, patients reduced their already low ICS use in response to losing drug coverage. Switching to the lower-cost ICS mitigated reductions in use among patients who previously used higher-cost drugs. Additional work is needed to assess barriers to switching ICS drugs and the clinical effects of these drug use changes.

Evaluation of inhaled corticosteroid (ICS) use before exacerbations in pediatric patients with asthma

Rationale NHBLI guidelines recommend chronic use of ICS as maintenance therapy in patients with mild to moderate persistent asthma. Many asthmatic patients, especially in the pediatric population, discontinue ICS use during periods when symptoms are minimal. This potentially causes asthma exacerbations leading to hospitalizations and emergency department (ED) visits. We assessed use of ICS before an asthma-related ED visit or hospitalization in pediatric patients. Methods Children aged 8 years or younger with an asthma diagnosis and pharmacy claim for an ICS were identified using a 6-month identification period (7/1/00-12/31/00) from an employer health care claims database comprising over 3.6 million patients, and followed for 360 days following the initial index ICS claim. In patients with an asthma-related ED visit or hospitalization, ICS use was examined in the time period immediately preceding the event. Results 3,334 patients with an ICS claim were identified, and there were 179 ED visits and 61 hospitalizations in the 360 days following the initial index ICS claim. Only 50 of the 179 ED visits (27.9%) and 20 of the 61 hospitalizations (32.8%) were associated with prior ICS use. Furthermore, patients were dispensed an ICS within 30 days following the ED visit or hospitalization in only 39.0% and 34.0% of cases, respectively. Conclusions Pediatric patients with an asthma-related ED visit or hospitalization are not likely to be receiving an ICS before the event. As outlined in national guidelines, these patients will benefit from persistent use of an ICS to maintain asthma control and possibly decrease ED visits or hospitalizations.