Receiving Controller Medications Research Articles

Real-World Treatment Patterns and Switching Following Moderate/Severe Chronic Obstructive Pulmonary Disease Exacerbation in Patients with Commercial or Medicare Insurance in the United States.

There is limited literature regarding real-world treatment patterns of patients with COPD, particularly since the introduction of once-daily single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol in 2017. Here, we evaluated treatment patterns of patients with COPD before and after a COPD exacerbation. Retrospective, descriptive study using medical and pharmacy claims data and enrollment information from the Optum® Clinformatics® Data Mart database. Patients aged ≥40 years with ≥1 COPD exacerbation on or after September 18, 2017 were included. The index date was the last day of the first COPD exacerbation (ie day of visit for a moderate exacerbation or discharge date for a severe exacerbation). The baseline period was 12 months prior to index and the follow-up period (≥3 months) spanned from index until the earliest of health plan disenrollment, end of data availability (September 30, 2020), or death. Treatment patterns were evaluated during baseline and follow-up, with a focus on medication switching in the 90 days pre- and post-index. COPD exacerbations were identified in 307,727 patients (125,942 severe; 181,785 moderate). Mean age at index was 72.8 years; 56.3% were female. Before and after first exacerbation, 37.7% and 48.2% of patients used ≥1 controller medication, respectively. In the 90 days pre-index, ICS, LABA, and LAMA medications were used by 27.5% of patients. Of these users, 64.3% remained on the same medication class, 21.7% discontinued, and 14.1% switched medication in the 90 days post-index. Among switchers, 44.0% switched to triple therapy. Most common switches were ICS/LABA to ICS/LABA/LAMA (20.7%) and LAMA to ICS/LABA/LAMA (16.4%). Many COPD exacerbations occur among patients not on controller medications. Although the percentage of patients receiving a controller medication increased following a first exacerbation, it remained below 50%. Of patients receiving controller medications pre-exacerbation, only a small proportion escalated to triple therapy post-exacerbation.

Combined use of fractional exhaled nitric oxide and bronchodilator response in predicting future loss of asthma control among children with atopic asthma.

Recognition of patients at risk of asthma exacerbation is important for future asthma care and improved outcome. The aim of the present study was to see whether measurements of bronchodilator response (BDR) and fractional exhaled nitric oxide (FeNO) in combination provide prognostic information superior to either measurement alone in children with atopic asthma. A total of 201 atopic children aged 8-16 years with intermittent or mild persistent asthma were included. Pulmonary function tests including BDR and FeNO were serially monitored 10 times or more over 2 years when subjects were not receiving controller medications. After completion of monitoring, 1-year observation for a loss of asthma control was performed. During the monitoring period, positive BDRs (≥12% in forced expiratory volume in 1 s (FEV1 ) from pre-bronchodilator value) and FeNO higher than 35 parts per billion (ppb) were observed at least once in 59% and 77% of participants. When analysed as continuous variables, both BDR (hazard ratio (HR): 1.21; 95% CI: 1.04-1.41; P = 0.014) and FeNO (HR: 1.27; 95% CI: 1.09-1.49; P = 0.003) were associated with increased risks for a control loss. Compared with patients showing either positive BDRs (HR: 3.19; 95% CI: 1.05-9.64) or FeNO higher than 35 ppb (HR: 4.70; 95% CI: 1.68-13.11), patients with both findings (HR: 7.08; 95% CI: 2.57-19.49) had greater risks for a control loss. These data support that combined use of BDR and FeNO measurements can modify predictive risk obtained from either measurement alone.

Association of longitudinal fractional exhaled nitric oxide measurements with asthma control in atopic children

We sought to determine whether longitudinal measurements of FeNO are informative for future loss of asthma control in children with atopic asthma. One hundred seventy-eight patients aged 8-16 years with atopic asthma were enrolled. FeNO and lung functions were serially monitored 10 times or more over 2 years when subjects were not receiving controller medications. After completion of monitoring, 1-year observation on the occurrence of loss of asthma control was performed and associations of loss of asthma control with spirometric and FeNO measurements were analyzed. Loss of asthma control occurred during observation periods in 110 (76%) of 145 patients who completed the study. Of all monitored parameters including airway reactivity, the highest FeNO of serial measurements (H-FeNO) (adjusted odds ratio (aOR), 1.21; 95% CI, 1.08-1.36) and the rate of FeNO levels higher than 21ppb (R21FeNO) (aOR, 1.06; 95% CI, 1.01-1.11) were the only independent predictors of upcoming control loss in the multiple logistic regression analysis. In receiver-operator characteristic curve analysis, H-FeNO>37ppb and R21FeNO>20% demonstrated 91% and 88% sensitivity for a future loss of asthma control at the cost of low specificity (60% and 65%, respectively). In contrast, H-FeNO>47ppb and R21FeNO>41% gave 96% and 88% specificity, but these sacrificed sensitivity to 70% and 72%, respectively. Our data show that both amount and frequency of a FeNO increase during longitudinal monitoring are helpful in predicting asthma control status.

ASTHMATIC CHILDREN

Objectives: To assess the knowledge, attitude and practices among caregiversof asthmatic children and to describe their clinical and biographic features. Material andmethods: A descriptive cross-sectional study was conducted in asthma clinic and medicalwards of children hospital P.I.M.S.100 diagnosed asthmatic children and their caregivers wereenrolled. Two questionnaire one comprising clinical aspects and other regarding knowledgeattitude and practices among caregivers were administered. Results: 100 asthmatic childrenand their caregivers participated. Among children, 77% were breastfed, 95% were immunized,only 13% were receiving controller medications and 62% were having >5 acute exacerbationsper year. Diagnosis of asthma was accepted by 76% of caregivers, of which 67% recognizedcorrect etiology. Multiple food items were blamed for acute exacerbations, while respiratoryinfections were most commonly recognized triggering factor. 50% of study population wasignorant of aerosol therapy and only 26% prefer it. Cough suppressants are most popular homemedications. Conclusions: Asthma awareness is inadequate. Controller medications andaerosol therapy is underused and unnecessarily blamed. Asthmatic children are deprived ofnutritious food considering them as triggering factors. Awareness raising strategies are neededin community.

Relationships of bronchodilator response with asthma control and fractional exhaled nitric oxide in children with atopic asthma

Purpose: Because bronchodilator response (BDR) is variable among asthmatic patients, there are practical limitations in using BDR to assess asthma control. We investigated the relationships of BDR with asthma control status and fractional exhaled nitric oxide (FeNO) in children with atopic asthma. Methods: One hundred ninety-one patients aged 8 to 16 years with atopic asthma were enrolled. Pulmonary function tests including BDR and FeNO were serially measured 10 times or more over 2 years when subjects were not receiving controller medications. During the last year of follow-up, the loss of asthma control was assessed in all participants. Results: We identified 114 children (60%) with at least 1 positive BDR (≥12%) over the 2-year observation period. Higher levels of BDRs and higher rates of positive BDRs were associated with lower lung function and lower methacholine PC20 (provocative concentration of methacholine causing a 20% fall in forced expiratory volume in one second). The loss of asthma control occurred in 106 of individuals (93%) who had positive BDRs, as compared to 52 of 77 (68%) with negative BDRs (P 21 parts per billion than those who maintained asthma control (all P<0.001). Conclusion: Positive BDRs are linked to a higher probability of asthma control loss in children with atopic asthma. In addition, high FeNO is associated with asthma control loss in asthmatic children with negative BDRs.

Methacholine challenge test: Diagnostic characteristics in asthmatic patients receiving controller medications

The methacholine challenge test (MCT) is commonly used to assess airway hyperresponsiveness, but the diagnostic characteristics have not been well studied in asthmatic patients receiving controller medications after the use of high-potency inhaled corticosteroids became common. We investigated the ability of the MCT to differentiate participants with a physician's diagnosis of asthma from nonasthmatic participants. We conducted a cohort-control study in asthmatic participants (n= 126) who were receiving regular controller medications and nonasthmatic control participants (n= 93) to evaluate the sensitivity and specificity of the MCT. The overall sensitivity was 77% and the specificity was 96% with a threshold PC(20) (the provocative concentration of methacholine that results in a 20% drop in FEV(1)) of 8 mg/mL. The sensitivity was significantly lower in white than in African American participants (69% vs 95%, P= .015) and higher in atopic compared with nonatopic (82% vs 52%, P= .005). Increasing the PC(20) threshold from 8 to 16 mg/mL did not noticeably improve the performance characteristics of the test. African American race, presence of atopy, and lower percent predicted FEV(1) were associated with a positive test result. The utility of the MCT to rule out a diagnosis of asthma depends on racial and atopic characteristics. Clinicians should take into account the reduced sensitivity of the MCT in white and nonatopic asthmatic patients when using this test for the diagnosis of asthma.

Asthma quality-of-care measures using administrative data: identifying the optimal denominator

INTRODUCTION The Healthcare Effectiveness Data and Information Set (HEDIS) was developed by the National Committee for Quality Assurance and has been applied to many diseases, including asthma.1 The National Committee for Quality Assurance attempts to create and facilitate HEDIS measures that reflect “quality care” that then may be used to identify plans offering such quality care and to compare results among plans. The HEDIS asthma measure identifies patients with “persistent asthma” based on inpatient, outpatient, and pharmacy utilization data and assesses the proportion of such patients dispensed at least 1 controller medication. Problems with this measure include that this administrative definition of persistent asthma may not adequately reflect persistent asthma as defined clinically2,3 and that patients who meet these criteria for appropriate treatment may actually be at increased risk for subsequent emergency hospital care.4,5 Since 2005, 2 years of continuous enrollment and qualification as “persistent asthma” have been required to increase the specificity of the HEDIS denominator.1 However, health plans may prefer a measure that can be applied to members with a single year of continuous enrollment so as to maximize the number of patients who can be evaluated. A Joint Task Force of the American Academy of Allergy, Asthma and Immunology and the American College of Allergy, Asthma and Immunology was convened to study this subject. Working with pharmaceutical company collaborators, a study5 was performed in 4 different commercial insurance data sets to try to identify an improved asthma quality-of-care measure using administrative data. The strategy was to test the relationship of different numerator-denominator combinations of medical and pharmacy claims in year 1 to asthma exacerbations in the subsequent year. A measure associated with reduced exacerbations would presumably be a better measure of quality care than would a measure not associated with reduced exacerbations. The main findings of this previous study5 were as follows: 1. Based on the lowest number of patients, the highest prevalence of controller use, and the highest prevalence of exacerbations in patients not receiving controller medications, the diagnosis plus 4 medications denominator was the most specific of the 1-year denominators tested for persistent asthma. 2. Compared with other numerators tested, the ratio measure (ratio of controllers to total medications 0.5) was most consistently associated with improved outcomes in all age groups with the more specific denominators. However, the previous Task Force report5 did not evaluate close alternative denominators (eg, 1 encounter with an asthma diagnosis plus 3 medications or 2 encounters plus 2 medication dispensings). The purpose of the present study was to test several additional denominators to define the optimal 1-year denominator to be used with the ratio measure. The main characteristic of the denominator being sought was optimal discrimination of the ratio in predicting acute asthma episodes. Other aspects of the denominators that were evaluated included the size of the denominator and the proportion of patients with medication ratios of 0.5 or greater.

Assessing the value of disease management: impact of 2 disease management strategies in an underserved asthma population

The goal of disease management (DM) is to improve health outcomes and reduce cost through decreasing health care utilization. Although some studies have shown that DM improves asthma outcomes, these interventions have not been examined in a large randomized controlled trial. To compare the effectiveness of 2 previously successful DM programs with that of traditional care. Nine hundred two individuals with asthma (429 adults; 473 children) were randomly assigned to telephonic DM, augmented DM (ADM; DM plus in-home visits by a respiratory therapist), or traditional care. Data were collected at enrollment and at 6 and 12 months. Primary outcomes were time to first asthma-related event, quality of life (QOL), and rates of asthma-related health care utilization. Secondary outcomes included rate of controller medication initiation, number of oral corticosteroid bursts, asthma symptom scores, and number of school days missed. There were no significant differences between groups in time to first asthma-related event or health care utilization. Adult participants in the ADM group had greater improvement in QOL (P = .04) and a decrease in asthma symptoms (P = .001) compared with other groups. Of children not receiving controller medications at enrollment (13%), those in the intervention groups were more likely to have controller medications initiated than the control group (P = .01). Otherwise, there were no differences in outcomes. Overall, participation in asthma DM did not result in significant differences in utilization or clinical outcomes. The only significant impact was a higher rate of controllermedication initiation in children and improvement in asthma symptoms and QOL in adults who received ADM.

Physician adherence to the national asthma prescribing guidelines: evidence from national outpatient survey data in the United States

The Expert Panel 2 Guidelines for the Diagnosis and Management of Asthma (EPR-2 guidelines) were developed to improve medication prescribing for patients with persistent asthma and to control acute exacerbations of asthma. In addition, these guidelines also encourage physician-provided asthma education. Little is known about prescribing adherence to EPR-2 guidelines. To examine physician adherence to EPR-2 asthma medication prescribing guidelines and determine patient and physician factors associated with prescribing of asthma medications. This study was a cross-sectional retrospective analysis of National Ambulatory Medical Care Survey physician visit survey data from 1998 through 2004. Data were extracted on all patients with an International Classification of Diseases, Ninth Revision (ICD-9) code for asthma (493.XX) and reason for visit as asthma. The unit of analysis was individual patient visit. The dependent variables in analyses were specific type of drug class. The independent variables were various patient and physician factors. Logistic regression analysis was used to evaluate study objectives. Asthma patients in 2002 had 3.3 times more odds of being prescribed controller medications compared with asthma patients in 1998. Findings in 2004 were not significant. Elderly patients had 54% less odds of receiving controller medication compared with those in the 35- to 64-year-old age group. Patients in the other race category are 40% as likely to receive controller asthma medication compared with white patients. Physicians in 2002 had 6.3 times more odds of prescribing long-acting beta-agonists compared with those in 1998. Physicians without ownership stake in their practice had 1.9 times more odds of providing asthma education to their patients compared with those who owned their practice. Physician prescribing of asthma pharmacotherapy does not adequately comply with EPR-2 treatment guidelines.

Current Asthma Guidelines May Not Identify Young Children Who Have Experienced Significant Morbidity

The current guideline for classifying asthma severity, the National Asthma Education Prevention Program (NAEPP) 2002, is not evidence-based. We had the opportunity to validate this guideline in an untreated inner-city population, both in those < or =5 and those >5 years of age. The basis for this retrospective validation model was to determine how well the NAEPP severity classification based on symptom-frequency criteria alone identified patients in those age groups demonstrating significant morbidity the previous year and thus the potential need for controller therapy. Using a mobile asthma van (Breathmobile) at the school site, children not receiving controller medication were evaluated by an asthma specialist for severity according to NAEPP guideline clinical criteria. Validation was determined by the relationship of guideline severity to > or =2 emergency department (ED) visits, any hospitalization, health care utilization (any ED visit, hospitalization), number of exacerbations, and school absenteeism resulting from asthma the prior year. Eight hundred twenty-six asthmatic children were evaluated; 89 (10.8%) were < or =2 years, 222 (26.9%) were 3 to 5 years, and 515 (62.3%) were >5 years of age; 60.5% were male, and 80.9% were Hispanic. Classification of asthma severity included 34.4% with mild intermittent, 10.2% with mild persistent, 31.5% with moderate persistent, and 24.0% with severe persistent asthma categories. There were significantly more Hispanic children and children < or =5 years classified as having mild intermittant asthma. Morbidity was clearly related to severity in the overall population. However, although the health care utilization was significantly related to severity, it was borderline in those 3 to 5 years and nonsignificant in children < or =2 years. The NAEPP guidelines 2002, based on symptom-frequency criteria as assessed in this study, seem to offer a valid basis for classifying asthma severity in those >5 years of age but may underclassify younger children. Our data suggest that morbidity experienced in the prior year may provide a useful additional criterion for classifying asthma severity, particularly in those children < or =5 years of age.

Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma

Outcome data are needed to base recommendations for controller asthma medication use in school-aged children. We sought to determine intraindividual and interindividual response profiles and predictors of response to an inhaled corticosteroid (ICS) and a leukotriene receptor antagonist (LTRA). An ICS, fluticasone propionate (100 mug twice daily), and an LTRA, montelukast (5-10 mg nightly, age dependent), were administered to children ages 6 to 17 years with mild-to-moderate persistent asthma using only as-needed bronchodilators in a multicenter, double-masked, 2-sequence, 16-week crossover trial. Clinical, pulmonary, and inflammatory responses to these controllers were evaluated. Improvements in most clinical asthma control measures occurred with both controllers. However, clinical outcomes (asthma control days [ACDs], the validated Asthma Control Questionnaire, and albuterol use), pulmonary responses (FEV(1)/forced vital capacity, peak expiratory flow variability, morning peak expiratory flow, and measures of impedance), and inflammatory biomarkers (exhaled nitric oxide [eNO]) improved significantly more with fluticasone than with montelukast treatment. eNO was both a predictor of ACDs (P = .011) and a response indicator (P = .003) in discriminating the difference in ACD response between fluticasone and montelukast. The more favorable clinical, pulmonary, and inflammatory responses to an ICS than to an LTRA provide pediatric-based group evidence to support ICSs as the preferred first-line therapy for mild-to-moderate persistent asthma in children. eNO, as a predictor of response, might help to identify individual children not receiving controller medication who achieve a greater improvement in ACDs with an ICS compared with an LTRA.

A Multisite Randomized Trial of the Effects of Physician Education and Organizational Change in Chronic Asthma Care

A decision to implement innovative disease management interventions in health plans often requires evidence of clinical benefit and financial impact. The Pediatric Asthma Care Patient Outcomes Research Team II trial evaluated 2 asthma care strategies: a peer leader-based physician behavior change intervention (PLE) and a practice-based redesign called the planned asthma care intervention (PACI). To estimate the cost-effectiveness of the interventions. This was a 3-arm, cluster randomized trial conducted in 42 primary care practices. A total of 638 children (age range, 3-17 years) with mild to moderate persistent asthma were followed up for 2 years. Practices were randomized to PLE (n = 226), PACI (n = 213), or usual care (n = 199). The primary outcome was symptom-free days (SFDs). Costs included asthma-related health care utilization and intervention costs. Annual costs per patient were as follows: PACI, USD 1292; PLE, USD 504; and usual care, USD 385. The difference in annual SFDs was 6.5 days (95% confidence interval [CI], -3.6 to 16.9 days) for PLE vs usual care and 13.3 days (95% CI, 2.1-24.7 days) for PACI vs usual care. Compared with usual care, the incremental cost-effectiveness ratio was USD 18 per SFD gained for PLE (95% CI, USD 5.21-dominated) and USD 68 per SFD gained for PACI (95% CI, USD 37.36-361.16). Results of this study show that it is possible to increase SFDs in children and move organizations toward guideline recommendations on asthma control in settings where most children are receiving controller medications at baseline. However, the improvements were realized with an increase in the costs associated with asthma care.

Emergency department discharge asthma action plans improve controller medication compliance in persistent asthmatics

Study objectives: The National Institutes of Health National Asthma Education and Prevention Program guidelines recommend chronic use of controller medications such as inhaled corticosteroids for all persistent asthmatic patients (step II or higher). Previous studies have demonstrated poor compliance with controller medication use in emergency department (ED) asthmatic patients. The purpose of this study is to determine whether discharging patients with a written asthma action plan from the ED will improve long-term compliance with controller medications. Methods: A prospective, grant-funded study of ED wheezing patients has been in place since November 2002. In phase II of this study, prospectively enrolled wheezing patients older than 12 months were treated for acute wheezing in an unrestricted fashion. For those discharged from the ED, parents were given a written asthma action plan along with other optional educational tools such as an asthma educational video while in the ED. Patients were later contacted by telephone to assess use of controller medications. Results: Of the 719 encounters (596 subjects) enrolled in phase I, 68 (9%) had written asthma action plans. Three hundred ninety-five encounters were assessed as persistent (step II or higher), and of these, 15% were using controller medications correctly, 12% were using controller medications intermittently, and 73% were not receiving controller medications. Two hundred forty-six patients were interviewed by telephone 2 to 4 weeks after the ED visit, and of these, 14% were using controller medications and 86% were not. The ED encounter alone failed to increase the appropriate use of controller medications. Among the first 160 patients enrolled in phase II, only 15 patients had written asthma action plans at the ED visit. One hundred fifty-two patients received a color-coded written asthma action plan on ED discharge, which clearly recommends inhaled corticosteroids even during well periods (color coded as green). For the 78 patients assessed as persistent asthmatics (step II or higher), the appropriate use of controller medications improved 2 to 4 weeks later, assessed during a telephone interview compared with controller medication use before the ED visit as follows: using controller medications appropriately (41% versus 18% previously), using controller medications intermittently (13% versus 21% previously), and not using controller medications at all (46% versus 62% previously). Conclusion: Appropriate controller medication compliance rates have increased with the interventions initiated in phase II of this study. The most consistent intervention in this cohort is a written asthma action plan provided from the ED. Although the long-term management of a chronic disease such as asthma is more optimally managed by primary care physicians, asthmatic patients who utilize the ED might have poorer access to or poorer compliance with primary care, and for these reasons, methods to improve long-term controller medication compliance can be enhanced by educational tools such as written asthma action plans provided by the ED and are faster and preferable.

Asthma medication use and disease burden in children in a primary care population.

Children with persistent asthma underuse controller medications and overuse relievers. A better understanding of the appropriateness of regimens, medication adherence, and adequacy of asthma control is needed. To describe use of asthma medications and disease burden in children with persistent asthma, to determine whether use of controllers and relievers is consistent with national guidelines, and to estimate adequacy of asthma control. Cross-sectional cohort study. Forty-two primary care practices participating in 3 regions of the United States. Parents of 638 children aged 3 to 15 years with asthma. Asthma symptom-days, use of reliever and controller medications, and adequacy of asthma control, ascertained by face-to-face questionnaire. The mean age was 9.4 years, and 59.9% were boys. In the preceding 2 weeks, two thirds (67.5%) of subjects had 0 to 4 symptom-days, 15.8% had 5 to 9 symptom-days, and 16.6% had 10 to 14 symptom-days (percentages do not total 100 because of rounding). One third (32.6%) of children using relievers had high levels of use. One third (34.3%) of children using controllers used them 4 or fewer days per week. Among children with some evidence of persistent disease (use of controllers, excess symptoms, or excess reliever use), almost two thirds (64.3%) were inadequately controlled. This group consisted both of children reportedly using controllers less than recommended and those reporting not receiving controller medication at all. In this insured population, inappropriate reliance on relievers and nonadherence to controllers were common. Inadequate asthma control was common regardless of whether controllers were prescribed.