A psychometric comparison of three patient-based measures of asthma control.

OBJECTIVE: Asthma is a multidimensional disease, characterized by changes in pulmonary function, transient and chronic symptoms, and effects on quality of life. In this study, we compared the psychometric properties and screening accuracy of three patient-based asthma control instruments including: the Asthma Control Test (ACT), a brief instrument developed to assess asthma control of patients in a clinical setting; the Asthma Control Questionnaire (ACQ), an instrument developed for use in clinical research; and the 'Rules of Two', a tool that has been used in both settings. METHODS: Patients (N = 313) completed the ACT, ACQ, and Rules of Two during two asthma clinic visits 4-12 weeks apart. Office staff recorded pre- and post-bronchodilator FEV(1) measurements and asthma specialists provided a global rating of asthma control. Internal consistency reliability was computed and construct validity was evaluated using analysis of variance (ANOVA). Logistic regression and receiving operating characteristic (ROC) curve analysis was conducted to compare the screening accuracy of each measure in identifying patients with uncontrolled or moderate to severe asthma. The responsiveness of each measure to changes in asthma control and severity was tested using correlational and ANOVA methods. RESULTS: Results show that the ACT and ACQ have comparable reliability, validity, screening accuracy, and responsiveness. The Rules of Two, however, did not meet some standards and therefore has weaker psychometric properties. CONCLUSION: The ACT and ACQ are comparable asthma control questionnaires. The choice of which questionnaire to use should be informed by considering several factors, such as the intended purpose and setting where the questionnaire will be used, as well as the content, practicality, availability of benchmark scores, and adaptability to multiple administration modes of each questionnaire. One potential limitation of the study is that the data were collected in a clinical setting with limited demographic information. Hence, additional studies are needed to evaluate the psychometric properties of each instrument across demographic and clinical subgroups of the general population.

The use of rhinitis medications in children receiving initial controller therapy for asthma.

BACKGROUND: Due to common features of asthma and allergic rhinitis, a single therapeutic approach to treating both of these conditions has been proposed. OBJECTIVE: To compare and contrast the use of rhinitis medications in a group of children initiating various controller therapies for asthma. METHODS: A retrospective, observational study using an integrated managed care database of children aged 4-17 years with an initial medical claim for asthma and an initial pharmacy claim for fluticasone propionate (FP) and salmeterol in a single inhaler (FSC), FP alone, montelukast (MON), or combination FP + MON. Outcomes included the percentage of children initiating controller asthma therapy with prescriptions for non-sedating antihistamine (NSA) and intranasal corticosteroids (INCS) and the mean number of prescriptions for NSA and INCS. RESULTS: A total of 5247 children were included. The percentage of children who filled prescriptions for NSA or INCS and the mean number of prescriptions dispensed was similar among children treated with FSC, FP, MON, and FP + MON. There were no significant differences in the relative risk of dispensing either a NSA or INCS across cohorts. Observational studies are limited by their use of administrative data and lack of access to patient records. CONCLUSIONS: Children started on common asthma controller therapy are frequent users of rhinitis medications. The quantity and frequency of these medications is not different between dispensed asthma regimens.

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

Comparative efficacy and safety of low-dose fluticasone propionate and montelukast in children with persistent asthma.

OBJECTIVE: To evaluate efficacy, safety, health outcomes, and cost-effectiveness of fluticasone propionate (FP) versus montelukast (MON) in 342 children (6 to 12 years of age) with persistent asthma. STUDY DESIGN: Randomized, double-blind, 12-week study of treatment with FP inhalation powder 50 mug twice daily or MON chewable 5 mg once daily for 12 weeks. RESULTS: Compared with MON, FP significantly increased mean percent change from baseline FEV1 (forced expiratory volume in 1 second) (P=.002), morning PEF (peak expiratory flow) (P=.004), evening PEF (P=.020), and percent rescue-free days (P=.002) at end point, and it significantly reduced nighttime symptom scores (P <.001) and mean total (P=.018), and nighttime (P <.001) albuterol use. Withdrawals from the study were more frequent with MON (21%) than with FP (13%). Adverse events (69% vs 71%) and mean end point to baseline 12-hour urinary cortisol excretion ratios were similar. Parents and physicians were more satisfied with FP treatment than with MON (P=.006 and P=.016, respectively, at Week 12). Mean total daily asthma-related cost per patient in the FP group was approximately one-third of that in the MON group ($1.25 vs $3.49). CONCLUSION: FP was significantly more effective than MON in improving pulmonary function, asthma symptoms, and rescue albuterol use. Both therapies had similar safety profiles. Parent- and physician-reported satisfaction ratings were higher with FP treatment, and asthma-related costs were lower.

The relationship between health-related quality of life, lung function and daily symptoms in patients with persistent asthma.

It is generally believed that there is a direct correlation between asthma control and a patient's health-related quality of life (HRQL). Objective and subjective measures of asthma control are used interchangeably. A retrospective analysis from 8994 patients from 27 randomized, controlled clinical trials with persistent asthma was conducted to determine the degree of association which exists between objective (lung function) and subjective (symptoms, quality of life) measures. Assessments were made via forced expiratory volume in 1-second (FEV1), self-reported symptoms and the Asthma Quality of Life Questionnaire (AQLQ) overall scores. Baseline percent predicted FEV1 was weakly correlated with baseline symptom-free days (SFD) and baseline overall AQLQ scores (r=0.11 and 0.09, respectively; P <0.001). Changes in percent predicted FEV1 correlated weakly with changes in SFD but was more strongly correlated with changes in overall AQLQ scores (r= 0.26 and 0.38, respectively; P <0.001). Additionally, SFD at both baseline and endpoint were moderately correlated with overall AQLQ scores at baseline and endpoint (r=0.36 and 0.44; P <0.001). This study suggests that the impact of asthma on a patients' HRQL is not fully accounted for by objective measures such as lung function. Thus, HRQL data complements rather than duplicates results from traditional, objective assessments of asthma control.

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.