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.

Electronic medication monitoring versus self-reported use of inhaled corticosteroids and short-acting beta2-agonists in uncontrolled asthma.

OBJECTIVE: Current standard of care, patient self-report and clinician estimation, overestimates true inhaled corticosteroids (ICS) adherence. We compare self-reported inhaled ICS and short-acting beta 2-agonists (SABA) use with objective data from electronic medication monitors (EMMs). METHODS: Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled. At visit one, participants' ICS and SABA inhalers were fitted with EMMs to track real-time medication usage over 14 days. Participants were asked to complete paper diaries to self-report medication usage over the same period. Participant self-report of ICS adherence and SABA use versus objective ICS adherence and SABA use was compared using Wilcoxon signed-rank tests. RESULTS: One hundred participants (80% female, mean age 48.5 years, 60% completed college, 80% privately insured) had complete data. Participant self-report (median (IQR): 0.8 (0.0, 2.0)) was greater than objectively measured (median (IQR): 0.43 (0.1, 2.1)) SABA use, but the difference was not statistically significant (P = 0.64). Participant self-report (median (IQR): 97 (67, 100)) was significantly greater than objectively measured (median (IQR): 75 (54, 93)) ICS adherence (P = 0.002). CONCLUSIONS: Significant discrepancies between self-report and objective ICS usage were observed. EMM can provide clinicians with accurate data on ICS medication taking behavior, thus reducing medication regimen complexity, side effects, and costs.

A randomised controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients.

Suboptimal adherence to maintenance therapy contributes to poor asthma control and exacerbations. This study evaluated the effect of different elements of a connected inhaler system (CIS), comprising clip-on inhaler sensors, a patient-facing app and a healthcare professional (HCP) dashboard, on adherence to asthma maintenance therapy.This was an open-label, parallel-group, 6-month, randomised controlled trial in adults with uncontrolled asthma (asthma control test (ACT) score less than 20) on fixed-dose inhaled corticosteroids/long-acting ß-agonist maintenance therapy (n=437). All subjects received fluticasone furoate/vilanterol ELLIPTA dry-powder inhalers for maintenance and salbutamol/albuterol metered-dose inhalers for rescue, with a sensor attached to each inhaler. Participants were randomised to one of five CIS study arms (allocation ratio 1:1:1:1:1) reflecting the recipient of the data feedback from the sensors, as follows: 1) maintenance use to participants and HCPs (n=87); 2) maintenance use to participants (n=88); 3) maintenance and rescue use to participants and HCPs (n=88); 4) maintenance and rescue use to participants (n=88); and 5) no feedback (control) (n=86).For the primary endpoint, observed mean±sd adherence to maintenance therapy over months 4-6 was 82.2±16.58% (n=83) in the "maintenance to participants and HCPs" arm and 70.8±27.30% (n=85) in the control arm. The adjusted least squares mean±se was 80.9±3.19% and 69.0±3.19%, respectively (study arm difference: 12.0%, 95% CI 5.2-18.8%; p<0.001). Adherence was also significantly greater in the other CIS arms versus the control arm. The mean percentage of rescue medication free days (months 4-6) was significantly greater in participants receiving data on their rescue use compared with controls. ACT scores improved in all study arms with no significant differences between groups.A CIS can improve adherence to maintenance medication and reduce rescue medication use in patients with uncontrolled asthma.

Assessing asthma control: comparison of electronic-recorded short-acting beta-agonist rescue use and self-reported use utilizing the asthma control test.

Background: Question 4 (Q4) of the Asthma Control Test (ACT) asks patients to report their SABA use over the prior 4 weeks, a criterion for evaluating the impairment domain of asthma control. Biases in recall may lead to a misclassification of asthma control and has implications for asthma control determination and management strategies.Objective: To correlate objective electronic-recorded short-acting beta-agonist (SABA) use with self-reported use via Q4 of the ACT.Methods: Patients ≥18 years of age with a self-reported diagnosis of asthma were enrolled in a digital health electronic medication monitoring (EMM) platform, which recorded the date and time of SABA actuations and prompted the completion of the ACT. The correlations between ACT Q4 responses and EMM-recorded SABA use were evaluated using Spearman's rank correlation coefficients.Results: 1,062 patients (mean age: 35.4 years, mean ACT: 16.3) were included in analyses. Higher Q4 scores, indicating lower SABA use, were moderately and negatively correlated with EMM-recorded SABA use (ρ = -0.59 [95% CI: -0.63, -0.54]). Thirty-five percent of patients underreported SABA use when comparing Q4 to EMM-recorded SABA use.Conclusions: While ACT Q4 and EMM-recorded use were moderately correlated, underreported SABA use on the ACT highlights the need for objective measures of SABA use in asthma control assessments. The use of EMM-recorded SABA data has the potential for clinicians to more accurately determine asthma control, guide changes to controller therapy, and estimate imminent exacerbation risk.

Building Bridges for Asthma Care: Reducing school absence for inner-city children with health disparities.

BACKGROUND: Children with asthma are at increased risk for experiencing health and educational disparities because of increased school absence. School nurses are well positioned to support asthma management and improve school attendance. OBJECTIVE: We sought to implement and assess the effect of the Building Bridges for Asthma Care Program on improving school attendance and measures of asthma control. METHODS: Children with asthma (age, 5-14 years) in the Denver Public School System (n = 240) and the Hartford Public School System (n = 223) were enrolled in the Building Bridges Program during the 2013-2014 and 2014-2015 school years and followed until the end of the second school year. The primary outcome was school absence, with secondary outcomes, including asthma control, measured based on Childhood Asthma Control Test or the Asthma Control Test scores and rescue inhaler use. RESULTS: Participants experienced a 22% absolute decrease in school absenteeism, the number of children with an Asthma Control Test/Childhood Asthma Control Test score of less than the control threshold of 20 decreased from 42.7% to 28.8%, and bronchodilator use greater than 2 times per week decreased from 35.8% to 22.9% (all changes were significant, P < .01). CONCLUSIONS: Children enrolled in the Building Bridges for Asthma Care Program experienced reduced school absence and improved asthma control.

Building Bridges for Asthma Care Program: A School-Centered Program Connecting Schools, Families, and Community Health-Care Providers.

Asthma imposes tremendous burden on children, families, and society. Successful management requires coordinated care among children, families, health providers, and schools. Building Bridges for Asthma Care Program, a school-centered program to coordinate care for successful asthma management, was developed, implemented, and evaluated. The program consists of five steps: (1) identify students with asthma; (2) assess asthma risk/control; (3) engage the family and student at risk; (4) provide case management and care coordination, including engagement of health-care providers; and (5) prepare for next school year. Implementation occurred in 28 schools from two large urban school districts in Colorado and Connecticut. Significant improvements were noted in the proportions of students with completed School Asthma Care Plans, a quick-relief inhaler at school, Home Asthma Action/Treatment Plans and inhaler technique (p < .01 for all variables). Building Bridges for Asthma Care was successfully implemented extending asthma care to at-risk children with asthma through engagement of schools, health providers, and families.

Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone.

BACKGROUND: The safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. METHODS: In this multicenter, randomized, double-blind trial, adolescent and adult patients (age, ≥12 years) with persistent asthma were assigned to receive either fluticasone with salmeterol or fluticasone alone for 26 weeks. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month. Patients were excluded from the trial if they had a history of life-threatening or unstable asthma. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization). Noninferiority of fluticasone-salmeterol to fluticasone alone was defined as an upper boundary of the 95% confidence interval for the risk of the primary safety end point of less than 2.0. The efficacy end point was the first severe asthma exacerbation. RESULTS: Of 11,679 patients who were enrolled, 67 had 74 serious asthma-related events, with 36 events in 34 patients in the fluticasone-salmeterol group and 38 events in 33 patients in the fluticasone-only group. The hazard ratio for a serious asthma-related event in the fluticasone-salmeterol group was 1.03 (95% confidence interval [CI], 0.64 to 1.66), and noninferiority was achieved (P=0.003). There were no asthma-related deaths; 2 patients in the fluticasone-only group underwent asthma-related intubation. The risk of a severe asthma exacerbation was 21% lower in the fluticasone-salmeterol group than in the fluticasone-only group (hazard ratio, 0.79; 95% CI, 0.70 to 0.89), with at least one severe asthma exacerbation occurring in 480 of 5834 patients (8%) in the fluticasone-salmeterol group, as compared with 597 of 5845 patients (10%) in the fluticasone-only group (P<0.001). CONCLUSIONS: Patients who received salmeterol in a fixed-dose combination with fluticasone did not have a significantly higher risk of serious asthma-related events than did those who received fluticasone alone. Patients receiving fluticasone-salmeterol had fewer severe asthma exacerbations than did those in the fluticasone-only group. (AUSTRI ClinicalTrials.gov number, NCT01475721.).

Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma.

BACKGROUND: Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children. METHODS: We randomly assigned, in a 1:1 ratio, children 4 to 11 years of age who required daily asthma medications and had a history of asthma exacerbations in the previous year to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization), as assessed in a time-to-event analysis. The statistical design specified that noninferiority would be shown if the upper boundary of the 95% confidence interval of the hazard ratio for the primary safety end point was less than 2.675. The main efficacy end point was the first severe asthma exacerbation that led to treatment with systemic glucocorticoids, as assessed in a time-to-event analysis. RESULTS: Among the 6208 patients, 27 patients in the fluticasone-salmeterol group and 21 in the fluticasone-alone group had a serious asthma-related event (all were hospitalizations); the hazard ratio with fluticasone-salmeterol versus fluticasone alone was 1.28 (95% confidence interval [CI], 0.73 to 2.27), which showed the noninferiority of fluticasone-salmeterol (P=0.006). A total of 265 patients (8.5%) in the fluticasone-salmeterol group and 309 (10.0%) in the fluticasone-alone group had a severe asthma exacerbation (hazard ratio, 0.86; 95% CI, 0.73 to 1.01). CONCLUSIONS: In this trial involving children with asthma, salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone. (Funded by GlaxoSmithKline; VESTRI ClinicalTrials.gov number, NCT01462344 .).

An evaluation of asthma medication utilization for risk evaluation and mitigation strategies (REMS) in the United States: 2005-2011.

PURPOSE: The purpose of this study was to assess drug utilization patterns of fluticasone propionate (FP)/salmeterol (SAL) combination (FSC) and SAL over the 7-year period of 2005-2011 in patients with asthma as part of the Risk Evaluation and Mitigation Strategies (REMS). METHODS: A descriptive, retrospective observational study utilizing national pharmacy data and employer-based claims data to characterize drug utilization patterns. RESULTS: For patients with asthma, the total number of FSC and SAL dispensings and users of FSC and SAL has declined between 2005 and 2011. During this period, FSC and SAL dispensing for asthma decreased 24% and 76%, respectively, with a more pronounced decline between 2010 and 2011 relative to other years. The total number of patients with asthma who were dispensed FSC has decreased by 10% among adults and by 40% in children and adolescents. While SAL-containing medications decreased, dispensing of FP monotherapy increased 39% during the same 7-year period. The number of patients dispensed FP for asthma has increased 47% in children 4-11 years of age, 72% in adolescents 12-17 years of age, and 6% in adults. SAL use without a controller was infrequent and decreasing, reported by 1.7% and 0.5% of patients with asthma in 2005 and 2011, respectively. CONCLUSIONS: In patients with asthma, use of FSC and SAL decreased between 2005 and 2011, while the use of FP increased. Use of SAL monotherapy was infrequent and declined during the study period. The data suggest that the substantial communication activities have encouraged appropriate prescribing of long-acting ß2-adrenergic agonist (LABA).

Is Once Versus Twice Daily Dosing Better for Adherence in Asthma and Chronic Obstructive Pulmonary Disease?

BACKGROUND: Patients with asthma and chronic obstructive pulmonary disease (COPD) may be prescribed once- or twice-daily dosing of controller inhalers. OBJECTIVE: To assess differences in controller adherence by dosing schedule and age. METHODS: Electronic medication monitors (EMMs) captured the date and time of inhaler actuations over 90 days in patients using the Propeller Health platform. Prescribed inhaler schedule was self-reported. Once- versus twice-daily schedule comparisons were assessed retrospectively using regressions adjusting for age. RESULTS: A total of 6294 patients with asthma and 1791 patients with COPD were included. On average, once-daily users had significantly higher median (interquartile range [IQR]) daily adherence than twice-daily users (asthma: 63.3 [IQR: 31.1, 86.7]% vs 50.3 [IQR: 21.1, 78.3]%, P < .001; COPD: 83.3 [IQR: 57.2, 95.6]% vs 64.7 [IQR: 32.8, 88.9]%, P < .001). This pattern persisted in all age groups, with the exception of 4- to 17-year-olds in asthma. The lowest adherence was in the young adult population (18- to 29-year-olds). The percentage of patients who achieved ≥80% adherence was significantly higher among once- versus twice-daily users in asthma (34.3% vs 23.6%, P < .001) and COPD (54.8% vs 38.6%, P < .001). The adjusted odds of once- versus twice-daily users achieving ≥80% adherence was 1.36 (95% confidence interval: 1.19-1.56, P < .001) in asthma and 1.73 (95% confidence interval: 1.38-2.17, P < .001) in COPD. Most once-daily patients with COPD took their medication in the morning versus at night; there was no difference in morning versus afternoon/evening administration in all other asthma and COPD groups. CONCLUSION: Patients with asthma and COPD who were prescribed once-daily versus twice-daily medications were more likely to adhere to their inhalers. Patients with COPD had higher adherence than those with asthma, possibly reflecting, in part, the older cohort age. The effect of greater adherence on exacerbations is a topic for future analysis.

Asthma in the elderly: Current understanding and future research needs--a report of a National Institute on Aging (NIA) workshop.

Asthma in the elderly is underdiagnosed and undertreated, and there is a paucity of knowledge on the subject. The National Institute on Aging convened this workshop to identify what is known and what gaps in knowledge remain and suggest research directions needed to improve the understanding and care of asthma in the elderly. Asthma presenting at an advanced age often has similar clinical and physiologic consequences as seen with younger patients, but comorbid illnesses and the psychosocial effects of aging might affect the diagnosis, clinical presentation, and care of asthma in this population. At least 2 phenotypes exist among elderly patients with asthma; those with longstanding asthma have more severe airflow limitation and less complete reversibility than those with late-onset asthma. Many challenges exist in the recognition and treatment of asthma in the elderly. Furthermore, the pathophysiologic mechanisms of asthma in the elderly are likely to be different from those seen in young asthmatic patients, and these differences might influence the clinical course and outcomes of asthma in this population.

Long-term treatment with fluticasone propionate/salmeterol via Diskus improves asthma control versus fluticasone propionate alone.

This 52-week study was designed to assess the safety and efficacy of fluticasone propionate/salmeterol combination (FSC) 250/50 micrograms versus fluticasone propionate (FP) 250 micrograms in subjects with persistent asthma symptomatic on open-label FP 100 micrograms. The primary objective of this study was to show that FSC 250/50 micrograms was superior to FP 250 micrograms at increasing pulmonary function as measured by forced expiratory volume in 1 second over a 52-week treatment period. A secondary objective was to compare the rate of asthma attacks defined as (1) a sustained 2-day decrease in morning peak expiratory flow or increase in albuterol use for 2 consecutive days, (2) an asthma exacerbation requiring systemic corticosteroids, or (3) an unscheduled clinic or hospital visit for acute asthma symptoms. Three hundred six subjects received FSC 250/50 micrograms and 315 subjects received FP 250 micrograms. Both treatments were administered twice daily. Treatment with FSC 250/50 micrograms resulted in a significant improvement in lung function compared with FP 250 micrograms (p < 0.001). Additionally, treatment with FSC 250/50 micrograms resulted in a reduction in the rate of exacerbations of asthma (i.e., requiring systemic corticosteroids or unscheduled urgent care intervention) compared with FP 250 micrograms (0.170 versus 0.273, respectively; p = 0.017). There was no differentiation between treatments for less severe attacks of asthma. FSC 250/50 micrograms showed consistently greater improvement in lung function, symptom control, and decreased albuterol use. In addition, FSC 250/50 micrograms-treated subjects experienced fewer severe asthma exacerbations than subjects treated with FP 250 micrograms.

Defining Optimal Medication Adherence for Persistent Asthma and COPD.

Adherence to prescribed medications for chronic respiratory disease is considered a keystone for successful management. There is little consensus, though, on how to measure adherence, what is optimal adherence, or the goals of appropriate medication utilization. These criteria may differ when studying medication utilization at the patient or population level. The role of consistent medication use in chronic respiratory disease is associated with better outcomes. Shared decision-making is one strategy to achieve appropriate levels of adherence that requires negotiation, compromise by both patient and provider. It also recognizes that both success and failure to achieve goals of adherence are shared. As such, we discuss the current understanding of adherence measures in respiratory disease and identify the need for more nuanced approaches to evaluate adherence to reach acceptable patient outcomes.

The relationship between objective app engagement and medication adherence in asthma and COPD: a retrospective analysis.

Digital health tools can promote disease self-management, but the association of smartphone app engagement and medication adherence is unclear. We assessed the relationship between objective smartphone app engagement and controller medication use in adults with asthma and COPD. We retrospectively analyzed data from participants enrolled in a digital self-management platform for asthma and COPD. Eligible adults had a smartphone and a paired electronic medication monitor (EMM). Longitudinal, mixed-effects logistic regressions estimated the relationship between daily app engagement (app opens, session duration) and daily controller medication use. Data from 2309 participants (71% asthma; 29% COPD) was analyzed. Opening the app (vs. not opening the app) was associated with significantly greater odds (OR (95% CI)) of using controller medications in asthma (2.08 (1.98, 2.19)) and COPD (1.61 (1.49, 1.75). Longer session duration was also associated with greater odds of using controller medications in asthma and COPD, but the odds of use attenuated with longer session duration in COPD. This study presents a novel assessment of the relationship between objectively-measured smartphone app engagement and controller medication use in asthma and COPD. Such insights may help develop targeted digital health tools and interventions.

Concurrent Improvement Observed in Patient-Reported Burden and Sensor-Collected Medication Use Among Patients Enrolled in a COPD Digital Health Program.

Background: The COPD assessment test (CAT) is an 8-item questionnaire widely used in clinical practice to assess patient burden of disease. Digital health platforms that leverage electronic medication monitors (EMMs) are used to track the time and date of maintenance and short-acting beta-agonist (SABA) inhaler medication use and record patient-reported outcomes. The study examined changes in CAT and SABA inhaler use in COPD to determine whether passively collected SABA and CAT scores changed in a parallel manner. Methods: Patients with self-reported COPD enrolled in a digital health program, which provided EMMs to track SABA and maintenance inhaler use, and a companion smartphone application ("app") to provide medication feedback and reminders. Patients completing the CAT questionnaire in the app at enrollment and at 6 months were included in the analysis. Changes in CAT burden category [by the minimally important difference (MID)] and changes in EMM-recorded mean SABA inhaler use per day were quantified at baseline and 6 months. Results: The analysis included 611 patients. At 6 months, mean CAT improved by -0.9 (95% CI: -1.4, -0.4; p < 0.001) points, and mean SABA use decreased by -0.6 (-0.8, -0.4; p < 0.001) puffs/day. Among patients with higher burden (CAT ≥ 21) at enrollment, CAT improved by -2.0 (-2.6, -1.4; p < 0.001) points, and SABA use decreased by -0.8 (-1.1, -0.6; p < 0.001) puffs/day. Conclusion: Significant and parallel improvement in CAT scores and SABA use at 6 months were noted among patients enrolled in a digital health program, with greater improvement for patients with higher disease burden.

The Impact of Patient Self-Monitoring Via Electronic Medication Monitor and Mobile App Plus Remote Clinician Feedback on Adherence to Inhaled Corticosteroids: A Randomized Controlled Trial.

BACKGROUND: Poor adherence to inhaled corticosteroids (ICSs) and overuse of short-acting beta2-agonists (SABAs) are associated with increased asthma morbidity. OBJECTIVE: To assess whether patient self-monitoring via electronic medication monitoring and smartphone application plus remote clinician feedback influences ICS and SABA use. METHODS: Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled in this 14-week study. Inhalers were fitted with electronic medication monitoring to track real-time usage. After a 14-day baseline, participants were randomly assigned to the treatment group where they received reminders and feedback on ICS and SABA use via a smartphone application and clinician phone calls, or control group without feedback. Linear mixed models compared the baseline percentage of SABA-free days and ICS adherence to the last 14 study days. RESULTS: Participants (n = 100) had a mean age of 48.5 years, 80% were female, 68% white, and 80% privately insured. The percentage of SABA-free days increased significantly in the treatment group (19%; 95% CI, 12 to 26; P < .01) and nonsignificantly in the control group (6%, 95% CI, -3 to 16; P = .18), representing a 13% (95% CI, 1-26; P = .04) difference. ICS adherence changed minimally in the treatment group (-2%; 95% CI, -7 to 3; P = .40), but decreased significantly (-17%; 95% CI, -26 to -8; P < .01) in the control group, representing a 15% (95% CI, 4 to 25; P < .01) difference. CONCLUSIONS: Patient self-monitoring via a digital platform plus remote clinician feedback maintained high baseline ICS adherence and decreased SABA use.

Pilot Study of a Patient Experience with an ELLIPTA Inhaler Electronic Medication Monitor and Associated Integrated System: A Prospective Observational Study Using the COPD Patient-Powered Research Network.

BACKGROUND: Electronic medication monitors (EMMs) are associated with decreased rescue inhaler use, symptom burden, and increased medication adherence in asthma. However, the use of EMMs in people with chronic obstructive pulmonary disease (COPD) using the ELLIPTA dry powder inhaler has not been studied. METHODS: This was an open-label, single-arm, prospective observational study of EMMs and associated application (app) use over 12 weeks and up to 24 weeks (April-October 2019) in people with self-reported COPD aged ≥40 years enrolled in the COPD Patient-Powered Research Network, using an ELLIPTA inhaler. The primary outcome was daily active use of the app over 12 weeks. Treatment adherence, rescue inhaler use, and participant satisfaction were assessed over the same period. RESULTS: Among the 122 participants, mean (standard deviation [SD]) proportion of days participants opened the app was 59.5% (31.4), 51.1% (33.5) and 41.3% (34.2) for Days 1-30, 31-60 and 61-90, respectively. Mean (SD) adherence to maintenance medication remained stable: 80.2% (22.7) and 79.9% (26.7) for Days 1-30 and 61-90, respectively. In participants using a rescue inhaler and EMM, mean (SD) rescue-free days increased from 18.5 (10.0; Days 1-30, n=51) to 21.4 (9.6; Days 61-90, n=48). Participants reported high levels of confidence in using the EMM, valued app reminders highly and reported high system satisfaction (mean [SD] scale: 1=low, 5=high; 4.6 [1.1], 4.3 [1.1] and 4.1 [1.1], respectively). CONCLUSIONS: Use of an ELLIPTA EMM with frequent app engagement, high participant satisfaction and decreased rescue medication use may aid COPD management.

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.