Is the assessment of asthma treatment efficacy sufficiently comprehensive?

The goal of asthma guideline therapy is to achieve disease control, by minimizing impairment and decreasing the risk of exacerbations and adverse effects of the disease and its treatment. The primary objective of most clinical trials of biologics for severe asthma is a reduction in exacerbation rate. Recently, studies with patients at the lower guideline steps have also selected exacerbation reduction as a primary objective. These trials in patients with milder disease frequently demonstrate statistically significantly fewer exacerbations, but their power calculations reflect larger sample size and smaller effect size. Exacerbations have a precise consensus definition, although a minimal clinically important difference has not been established. Reduction of exacerbations in severe asthma is commonly 10-fold greater than in mild disease. Further, reduction in exacerbations is not always associated with reduced impairment. If superior control is the objective, both domains should demonstrate consistent and parallel improvement. The disconnect may reflect the need for alternative tools for measurement of impairment or, possibly, different therapeutic mechanisms of action. Determining response to biologics or discussion of disease remission requires assessing symptoms that may occur daily rather than focusing on exacerbations that occur once or twice a year for patients at the highest steps of care according to the guidelines.

Higher short-acting beta-agonist use is associated with greater COPD burden.

INTRODUCTION: The COPD Assessment Test (CAT) is a self-administered questionnaire that measures symptomatic burden. CAT is used as part of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines refined ABCD tool and is usually performed during office visit assessment. Electronic medication monitors (EMMs) capture utilization of short-acting beta-agonists (SABA) that may indicate disease worsening in real-time. The primary objective was to assess the relationship of CAT with SABA utilization. METHODS: From 8/2017-1/2019, COPD patients ≥40 years of age were enrolled in a digital health platform consisting of EMMs and a mobile application to track time and date of SABA use. Patients with a completed CAT and ≥81 days of continuous EMM data were included in analyses. Using one-way ANOVA, SABA use and maintenance medication adherence were compared by CAT score categories: <10 (low burden), 10-20 (medium), 21-30 (high), and 31-40 (very high). Associations were additionally estimated in patients who used ≥1 puff/week of their rescue and maintenance medication. RESULTS: The population included 2196 COPD patients (mean age: 60 years). CAT scores from low to high burden were associated with greater SABA use, from 0.8 to 1.9 puffs/day (+1.1 [95% CI: 0.6, 1.6 puffs/day], P < 0.001), and lower adherence, from 69% to 59%, (-10% [95% CI: -1, -19%], P = 0.04). Sensitivity analyses yielded similar results. CONCLUSIONS: This study found a significant association between greater SABA use and lower adherence with higher burden CAT scores. This finding may suggest that passive collection of inhaled medications could serve as a surrogate for CAT.

Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population.

BACKGROUND: The aim of this study was to extend previous findings and determine the value of prompt initiation of maintenance treatment (MT) following COPD exacerbations requiring hospitalization or an emergency department (ED) visit. PATIENTS AND METHODS: Administrative claims data (collected between January 1, 2009 and June 30, 2012) from an employer-sponsored commercially insured population were retrospectively used to identify patients with a COPD exacerbation resulting in hospitalization or an ED visit. Patients initiating approved MT for COPD within 30 days of discharge/diagnosis (prompt) were compared with those initiating MT within 31-180 days (delayed). COPD-related total, medical, and prescription drug costs during a 1-year follow-up period were evaluated using semilog ordinary least square regressions, controlling for baseline characteristics plus COPD-related costs from the previous year. The odds and number of subsequent COPD-related exacerbations during the follow-up were compared between the prompt and delayed cohorts using logistic regression and zero-inflated negative binomial models, respectively. RESULTS: A total of 6,521 patients with a COPD-related hospitalization or an ED visit were included, of whom 4,555 received prompt MT and 1,966 received delayed MT. Adjusted COPD-related total and medical costs were significantly lower for the prompt MT than the delayed MT cohorts (US$3,931 vs US$4,857 and US$2,327 vs US$3,087, respectively; both P<0.010), as were COPD-related prescription costs (US$1,526 vs US$1,683, P<0.010) during the 1-year follow-up period. Patients receiving delayed MT were 68% more likely to have a subsequent exacerbation requiring hospitalization and 80% more likely to have an exacerbation requiring an ED visit. CONCLUSION: Prompt initiation of MT following a COPD-related hospitalization or an ED visit was associated with a significant reduction in COPD-related costs and odds of exacerbation in the following year compared with delayed initiation.

Adding salmeterol to fluticasone propionate or increasing the dose of fluticasone propionate in patients with asthma.

The National Asthma Education and Prevention Program guidelines recommend two options for patients uncontrolled on inhaled corticosteroid (ICS) alone: add a long-acting bronchodilator or increase the dose of the ICS. The purpose of this study was to compare asthma-related exacerbations and asthma control in asthma patients receiving fluticasone propionate (FP) monotherapy with an increased dose of FP compared with maintaining the dose and adding salmeterol (SAL) via a single device (FP/SAL combination [FSC]). A retrospective observational study was performed using health insurance claims spanning from January 2001 to August 2006 ("study period"). Subjects were > or =12 years of age, with asthma (International Classification of Diseases [ICD] 493.xx), and were stepped up from FP 44 microg to either FP 110 microg (FP110) or FP 100 microg/SAL 50 microg (FSC), or from FP110 to either FP 220 microg or FP 250 microg/SAL 50 microg (FSC). There were 1744 subjects identified, 557 (32%) increased FP and 1187 (68%) added SAL. The cohorts were relatively similar, and after adjusting for baseline characteristics, patients who added SAL to their same dose of FP had 41% lower odds of an asthma exacerbation (odds ratio = 0.59; 95% confidence interval [CI] = 0.46-0.76; p < 0.001), 36% fewer prescriptions for a short-acting beta-agonist (rate ratio = 0.64; 95% CI = 0.58-0.70; p < 0.001), and a 32% increase in ICS refill persistence compared with increasing the dose of FP. In asthma patients who are not adequately controlled with ICS (FP), adding SAL as FSC is associated with lower risk of an asthma-related exacerbation and better asthma control compared with increasing the dose of ICS (FP).

Stepping down to fluticasone propionate or a lower dose of fluticasone propionate/salmeterol combination in asthma patients recently initiating combination therapy.

Clinical guidelines recommend add-on therapy with long-acting beta2-agonists (LABA) in patients with mild-to-moderate persistent asthma whose disease is not adequately controlled with inhaled corticosteroids (ICSs) alone. For those achieving control with add-on therapy, careful reduction in ICS dose followed by withdrawal of LABA is recommended. This study was designed to compare asthma-related outcomes in patients receiving fluticasone propionate/salmeterol combination (FSC) who stepped down to a lower dose of FSC versus those who stepped down to fluticasone propionate (FP) at the same dose of FP. A retrospective observational cohort study was performed using two large health insurance claims databases spanning from January 2000 to June 2007. Subjects were age > or =12 and <65 years, had a diagnosis of asthma (International Classification of Diseases [ICD-493.xx]), and who within 1 year of initiating FSC either stepped down to a lower dose of FSC ("FSC patients") or to FP only at the same dose of FP ("FP patients"). FSC and FP patients were matched based on propensity scores to control for potential differences in baseline demographic and clinical characteristics and preindex asthma-related and costs. Of 4350 subjects identified, 3881 stepped down to a lower dose of FSC and 469 stepped down to FP. After matching, there were 447 pairs of FSC and FP patients. FSC patients had 30% fewer prescriptions for short-acting beta-agonists, a 26% lower risk of receiving systemic corticosteroids, and a 48% lower risk of asthma-related hospitalization or Emergency Department visit during follow-up. Stepping down to FP monotherapy is associated with worsening asthma symptoms and greater risk of severe asthma-related exacerbations compared with staying on FSC at a lower ICS dose.

Controller medications and their effects on asthma exacerbations temporally associated with upper respiratory infections.

BACKGROUND: Exacerbations are a major risk and a cause of asthma morbidity and healthcare utilization. Viral-induced upper respiratory tract infections are the most frequent trigger of asthma-related exacerbations. Studies have traditionally assessed exacerbations without documentation regarding exacerbation etiology. Therefore, it remains unknown whether asthma medications can alter exacerbation susceptibility based on a specific etiology. OBJECTIVE: To examine whether treatment with inhaled corticosteroids plus long-acting beta(2)-agonists reduced the number of exacerbations associated with upper respiratory tract infections versus inhaled corticosteroids alone. METHODS: Two large datasets comparing treatment with fluticasone propionate and fluticasone propionate plus salmeterol were analyzed, including the number of clinically reported upper respiratory tract infections, asthma-related exacerbations, and the presence of an exacerbation and concurrent report of an upper respiratory tract infection. RESULTS: Both treatment groups had similar incidences of upper respiratory tract infections. Of those reporting an upper respiratory tract infection, statistically significantly fewer reported an asthma-related exacerbation comparing fluticasone propionate plus salmeterol with fluticasone propionate (p=0.0057). DISCUSSION: This retrospective analysis suggests that therapy with fluticasone propionate plus salmeterol provides protection against asthma exacerbations temporally associated with upper respiratory tract infections. This retrospective analysis supports the hypothesis that specific therapeutic approaches to mitigate virus-associated exacerbations may benefit asthma care. Well-controlled prospective studies are warranted.

Association between adherence with fixed dose combination fluticasone propionate/salmeterol on asthma outcomes and costs*.

OBJECTIVE: To assess the association between adherence with fluticasone propionate/salmeterol combination (FSC) product in a single inhaler and asthma care utilization and costs in asthma patients in typical US clinical practice. METHODS: Retrospective longitudinal analysis using linked medical and pharmacy claims from a managed care database representing >70 US health plans. Subjects included those with two prescriptions for FSC after January 1, 2000 (first prescription = 'index date') and diagnosis of asthma. Follow-up was defined as time from index date to disenrollment or discontinuation of FSC (180 days without supply), receipt of different controller, or 24 months post-index. Patients were excluded if: <12 months continuous enrollment pre-index, <12 months of follow-up, diagnoses of COPD or respiratory cancer, use of ipratropium, or age <12 years. Effect of FSC adherence on asthma-related outcomes (short-acting beta-agonist use (SABA), corticosteroid use (CS), emergency department (ED) visit/hospitalizations) and asthma-related health plan costs during each quarter post-index and FSC adherence in prior quarter controlling for demographics, time since index, season, comorbidities, pre-index medications, utilization, and cost. RESULTS: 12 907 patients were identified: mean age, 40 years; mean follow-up, 20 months; mean quarterly FSC adherence, 54%; mean quarterly incidence of asthma-related ED visit/hospitalization, 1.12%. After adjusting for baseline characteristics, each 25% improvement in adherence was associated with a 10% reduction in the odds of asthma-related ED visit or hospitalization (p < 0.001), a 10% reduction in the odds of receiving SABA (p < 0.001), a 3% reduction in the odds of receiving a CS (p = 0.027). However, total asthma-related costs also increased 23% for each 25% increase in the use of FSC. CONCLUSIONS: Despite the limitations of the study, this analysis shows that improving compliance with an asthma controller medication such as FSC may help reduce the burden of asthma.

A new focus on assessing and treating asthma control in the African-American community: a call to action.

Asthma continues to be a highly prevalent disease characterized by significant morbidity, unnecessary mortality, and substantial cost to the health care system. After decades of increasing prevalence, the number of current asthmatics in recent years has plateaued at approximately 22 million people in the United States. An additional 10 million Americans have a past history of asthma that is not active. The burden of asthma is higher among African Americans than in any other racial or ethnic group in America. The African-American community continues to experience a disproportional increase in asthma prevalence, morbidity, and mortality. The educational initiatives stemming from the newly revised National Heart Lung and Blood Institute (NHLBI) guidelines provide the opportunity to address the increased burden of asthma in the African American community. These new guidelines, released in August 2007, focus on asthma control as the primary goal of therapy, routine monitoring of asthma control, and use of asthma control assessments to direct treatment. The present review discusses the following: I. The impact of health disparities on outcomes of African Americans with asthma, II. The barriers that prevent asthmatic patients from achieving optimal control, III. The unique factors that challenge practitioners and patients in achieving optimal asthma control in the African American Community, IV. The impact of good asthma control and the need for patients and clinicians to assess asthma control in with a standardized assessment tool, and V. Strategic initiatives and the role of the End The Attacks NOW program in improving outcomes for African American patients with asthma.

Effects of fluticasone propionate/salmeterol combination on asthma-related health care resource utilization and costs and adherence in children and adults with asthma.

BACKGROUND: Clinical trials suggest that in patients with asthma inadequately controlled on low- to medium- dose inhaled corticosteroids (ICSs), the addition of a long-acting beta-agonist such as salmeterol (SAL is more effective than the addition of montelukast (MON) or a higher-dose ICS. OBJECTIVE: This study was designed to expand on these earlier findings by comparing asthma-related health care resource utilization and costs, as well as adherence to ICSs, in children and adults with asthma receiving ICS monotherapy who either were switched to fluticasone propionate plus SAL from a single inhaler (FSC) or initiated add-on therapy with SAL from a separate inhaler or MON. METHODS: This retrospective study used an integrated managed-care database from >30 health plans. Patients were >or=5 years of age with a diagnosis of asthma (International Classification of Diseases, Ninth Revision, Clinical Modification 493.xx) and >or=2 claims for FSC, SAL, or MON. The date of first claim for the medication of interest was the index date. Patients were also required to have >or=1 claim for an ICS during the 12 months preindex and 12 months postindex. Utilization and costs of asthma-related care and adherence to ICS treatment postindex were compared using multivariate methods. RESULTS: After adjusting for preindex characteristics, patients receiving FSC (n=1287) had fewer claims for short-acting beta-agonists, oral corticosteroids, and lower adjusted asthma-related costs postindex compared with ICS + SAL (n=562) and ICS + MON (n=420). FSC patients also had greater adherence to ICS therapy. Those who received FSC had lower risks for treatment failure (defined as asthma-related emergency department visits or hospitalization or receipt of alternative study medication or oral corticosteroids during the postindex period). CONCLUSION: In this health insurance claims-based study of patients with asthma inadequately controlled with an ICS alone, those who received stepped-up therapy with FSC used fewer rescue medications and had greater persistence with ICSs compared with those in whom SAL or MON was added to ICS monotherapy.

Comparative efficacy and cost of asthma care in children with asthma treated with fluticasone propionate and montelukast.

OBJECTIVE: To assess the comparative efficacy of fluticasone propionate (FP) and montelukast (MON), using administrative claims for pediatric asthma in a clinical setting. STUDY DESIGN: This retrospective observational study used the PharMetrics Integrated-Outcomes Database. Children age 4 to 17 years with an ICD-9-CM 493.xx for asthma, therapy with an inhaled corticosteroid in the 12 months before the index medications, and an index claim for FP or MON between January 2001 and December 2003 were studied. FP- and MON-treated children were propensity-matched based on health care utilization. Asthma-related parameters studied included treatment failure, hospitalizations, and total cost of care. RESULTS: The children treated with MON were more likely to experience treatment failure (odds ratio [OR] = 2.55; 95% confidence interval [CI] = 2.19 to 2.96) and to be admitted to the hospital for asthma-related care (OR = 1.99; 95% CI = 1.15 to 3.44) compared with those treated with FP. Furthermore, the children treated with MON incurred significantly higher asthma-related treatment costs compared with those treated with FP (parameter estimate = 0.418; P < .0001). CONCLUSIONS: In children with asthma, treatment with FP is associated with better outcomes and lower cost than treatment with MON.

Single-inhaler combination therapy for asthma: a review of cost effectiveness.

Clinical studies have shown that the combination of an inhaled corticosteroid (ICS) and a long-acting beta(2)-adrenoceptor agonist (LABA) for patients with asthma is more effective than the use of ICS alone in equivalent or higher doses, as well as the use of other combinations. However, the relatively higher acquisition costs for the combination therapy require assessment of the value of the incremental costs, especially from a societal perspective. This review provides an overall assessment of the cost effectiveness of ICS plus LABA combination therapy for asthma. A systematic literature research was conducted in MEDLINE to identify studies published between January 1994 and September 2005. Cost-effectiveness studies derived from 11 clinical studies were identified. The ICS plus LABA combination was compared with ICS alone in eight studies, ICS plus a leukotriene antagonist in two studies, and a leukotriene antagonist alone in one study. All studies focused on measuring direct medical costs in a total of six different healthcare systems, and three studies conducted sensitivity analyses, including productivity costs. Outcomes were measured in treatment success (changes in lung function), episode-free days, and symptom-free days by evaluating short-term follow-up. The combination of ICS and LABA was found to be more efficacious and cost effective compared with ICS alone or alternative combinations of controller medications. Further considerations for measuring long-term outcomes and dose-response relationships might be required to provide further evidence on the cost effectiveness of combination therapy with ICS plus LABA.

The economic impact of children dispensed asthma medications without an asthma diagnosis.

OBJECTIVE: To compare the resource utilization and healthcare costs of children with a diagnosis of asthma, children dispensed asthma medications but without a diagnosis of asthma, and control children. STUDY DESIGN: Children 0 to 17 years old were identified from an integrated managed-care database during calendar year 2001. They were compared on the basis of the presence of a medical claim for asthma (Dx cohort); a prescription for an asthma controller or reliever medication (excluding oral corticosteroids) but without an asthma diagnosis (Rx cohort), and control children. Using medical and pharmacy claims, resource utilization and costs were compared across cohorts. RESULTS: Children in both the Dx and Rx cohorts had significantly greater nonasthma and total all-cause annual healthcare costs compared with control children. The Dx and Rx cohorts had higher rates of nonasthma emergency department visits and hospitalizations. The risk of an oral corticosteroid dispensed was 14-fold and 7-fold greater for the Dx and Rx cohorts, respectively, compared with the control children. These findings were consistent in infant, toddler, school-age, and adolescent groups. CONCLUSIONS: Children dispensed asthma medications but lacking an asthma diagnosis have considerable morbidity and incur high healthcare resource utilization. This study suggests that better recognition of pediatric asthma is warranted.

Resource utilization with fluticasone propionate and salmeterol in a single inhaler compared with other controller therapies in children with asthma.

OBJECTIVE: To determine resource utilization in controller naïve children diagnosed with asthma receiving initial therapy with fluticasone propionate (FP) and salmeterol (SAL) in a single inhaler (FSC), FP alone, montelukast (MON), inhaled corticosteroid (ICS) + SAL from separate inhalers, or ICS + MON. RESEARCH DESIGN AND METHODS: A retrospective, observational, 18-month (6-month pre-index and 12-month follow-up) database study using medical and pharmacy claims from a 5 million member managed care organization. Multivariate modeling was used to evaluate post-index resource utilization and asthma-related costs. Refill rates during the 12-month follow-up period were compared across cohorts. RESULTS: The study included controller-naïve children (n = 9192) aged 4-17 years with an asthma diagnosis. Children treated with FSC were significantly less likely to receive additional prescriptions for short-acting beta-agonists compared with all other cohorts (p

Assessment of asthma control in a general population of asthmatics.

BACKGROUND: Asthma control is typically assessed by review of symptoms and measurement of airflow obstruction by clinic spirometry or outpatient peak flow. Recently the role of questionnaires to assess asthma control has been discussed. STUDY OBJECTIVE: To investigate the frequency of asthma control in the general population using the Asthma Control Test ([ACT], ACT is a trademark of QualityMetric, Lincoln RI) and force expiratory volume in one second (FEV1). RESEARCH DESIGN AND METHODS: Subjects with self-reported physician diagnosed asthma or use of asthma prescription medications attending community or sporting events were asked to complete the five-question ACT and to perform spirometry. Subjects with an ACT score of < or = 19 and/or an FEV1 of < 80% predicted were classified as having not well controlled (NWC) asthma. RESULTS: 2702 subjects completed both the ACT and spirometry. ACT scores < or = 19 were recorded in 27% and FEV1 < 80% predicted was noted in 26% of subjects evaluated. ACT and/or lung function was in the NWC range for 43% of subjects; 10% of subjects had both an ACT score < or = 19 and an FEV1 < 80% and 16-17% had either an ACT score < or = 19 or a FEV1 < 80%. CONCLUSION: A considerable portion (43%) of subjects with self-reported asthma in the general population was identified with NWC. In addition, the use of ACT and spirometry were equally effective methods to identify NWC asthma.

Asthma-related exacerbations, therapy switching, and therapy discontinuation: a comparison of 3 commonly used controller regimens.

BACKGROUND: Asthma control is the goal of therapeutic interventions. In observational studies, the use of short-acting beta-agonists (SABAs) is a surrogate for symptoms and emergency department or hospital events for exacerbations. OBJECTIVE: To compare asthma exacerbations, medication switch, and use of SABAs among 3 treatment cohorts: fluticasone propionate and salmeterol as a single inhaler (FSC), fluticasone and salmeterol as separate inhalers (FP + SAL), and fluticasone propionate alone (FP). METHODS: Administrative claims data from approximately 10 million individuals from April 2000 to December 2002 were examined. Patients 15 years or older with claims for asthma, SABAs, and study medications were included in the study. Asthma-related medical and pharmacy claims were evaluated. Multivariate regression techniques were used to model the outcomes of interest, controlling for patient characteristics. RESULTS: The odds of a hospitalization or emergency department event were significantly lower for the patients receiving FSC (n=1013) compared with those receiving FP (n=1130) (odds ratio, 0.75; 95% confidence interval, 0.61-0.93) and those receiving FP + SAL (n=271) (odds ratio, 0.69; 95% confidence interval, 0.51-0.95). Patients receiving FSC also had a significantly lower risk of switch or discontinuation of index medication and lower rates of postindex SABA use. CONCLUSION: In this analysis, patients receiving FSC had lower rates of asthma-related symptoms and exacerbations as measured by SABA refills and hospitalization, respectively, when compared with patients receiving either FP or FP + SAL. This observational examination of medical and pharmacy claims data adds to the clinical reports that demonstrate the increased effectiveness of FSC when compared with FP or FP + SAL.

Rates and characteristics of intensive care unit admissions and intubations among asthma-related hospitalizations.

BACKGROUND: A life-threatening attack of asthma that leads to intensive care unit (ICU) admission, intubation, or both identifies patients at high risk of subsequent morbidity and mortality and represents a major cost burden. OBJECTIVE: To assess the rates, characteristics, and costs of ICU admissions and intubations among asthma-related hospitalizations. METHODS: This analysis was performed using a database of 215 hospitals representing more than 3 million annual inpatient visits. Asthma-related hospital admissions were identified by a primary diagnosis code for asthma during 2000. Logistic regression was used to estimate the odds ratios (ORs) for predictors of ICU admission, intubation, and in-hospital mortality. Ordinary least squares regression was used to estimate adjusted mean costs and length of stay. RESULTS: Of 29,430 admissions with a primary diagnosis of asthma, 10.1% were admitted to the ICU and 2.1% were intubated. The risk of in-hospital death was significantly greater in patients who were intubated but not admitted to the ICU (OR, 96.20; 95% confidence interval [CI], 50.24-184.20), those who were admitted to the ICU and intubated (OR, 62.69; 95% CI, 38.17-102.96), and patients with more severe comorbidities (OR, 1.53; 95% CI, 1.38-1.70). On average, intubated patients stayed in the hospital 4.5 days longer and incurred more than $11,000 in additional costs; patients admitted to the ICU stayed 1 day longer and accounted for $3,000 in additional costs vs standard admissions. CONCLUSIONS: The inpatient mortality, morbidity, and cost burden of life-threatening asthma in the United States is considerable. This study characterizes patients with asthma at risk of ICU admissions and intubations. Appropriate recognition and treatment are needed to prevent these severe and potentially life-threatening events.

Improved refill persistence with fluticasone propionate and salmeterol in a single inhaler compared with other controller therapies.

BACKGROUND: Improved adherence to inhaled corticosteroids (ICSs) has also been associated with decreased asthma-associated morbidity and mortality. OBJECTIVE: The purpose of this study was to assess patient medication refill persistence with fluticasone propionate (FP) and salmeterol combination in a single inhaler (FSC), FP and salmeterol in combination from 2 separate inhalers, FP and montelukast in combination, FP as monotherapy, and montelukast as monotherapy. METHODS: We performed a retrospective, observational, 24-month (12-month baseline and 12-month follow-up) database study using medical and pharmacy claims from a large managed care organization. We identified 2511 subjects 12 years of age or older with a claim for asthma (International Classification of Diseases, Ninth Revision: 493.XX): 563 patients receiving FSC, 224 receiving FP plus salmeterol, 75 receiving FP plus montelukast, 798 receiving FP only, and 776 receiving montelukast only. Refill rates of FP, as a measure of adherence, were compared for each FP-containing cohort during the 12-month follow-up period. In addition, refill rates were compared between FSC, an inhaler, and montelukast, an oral medication. RESULTS: Twelve-month baseline asthma medication use and patient demographics were comparable among cohorts. Patients in the FSC cohort obtained significantly more refills compared with the number of FP refills in the other FP-containing cohorts (4.06 for FSC vs 2.35 for FP plus salmeterol, 1.83 for FP plus montelukast, and 2.27 for FP alone) over the 12-month follow-up period. In addition, patients taking FSC had similar refill persistence compared with patients taking the oral leukotriene modifier montelukast (4.51). CONCLUSION: FSC might increase ICS refill persistence compared with FP alone in a single inhaler, FP in combination with salmeterol from 2 separate inhalers, and FP in combination with montelukast. In addition, FSC in a dry powdered inhaler had similar refill rates compared with an oral asthma agent, montelukast. Use of a single inhaler containing both an ICS (FP) and a long-acting bronchodilator (salmeterol) might increase the likelihood that patients are getting more optimal ICS therapy, as well as the benefits from the long-acting bronchodilator, with patient adherence comparable to an oral agent.