Asthma patients' and physicians' perspectives on the burden and management of asthma.

BACKGROUND: The 2021 Global Initiative for Asthma (GINA) report recommends as-needed inhaled corticosteroid (ICS)/formoterol irrespective of severity, and maintenance and reliever treatment (MART) from GINA Step 3 as part of Treatment Track 1, partly based on the SYGMA studies. We investigated how current clinical practice in Australia, Canada, China and the Philippines relates to latest GINA recommendations. METHODS: Patients and physicians were recruited from online panels between July and August 2020 and invited to complete an online survey. INCLUSION CRITERIA: age ≥18 years, current/past physician diagnosis of asthma (patients); primary care (Canada also included respirologists/respiratory therapists), treating ≥4 patients with asthma per month, ≥3 years in clinical practice (physicians). RESULTS: Overall, 1216/70,183 patients and 803/8376 physicians replied and were eligible for inclusion. Only 8-15% of patients were using MART; 66-81% used regular maintenance therapy with/without an as-needed reliever. Across the four countries, physicians classified 48-63% of their patients as mild (GINA Steps 1-2) and 28-36% as moderate (GINA Steps 3-4). Generally, physicians rated symptom control over exacerbation reduction as their main treatment goal; patients also ranked symptom relief as very important. Approximately 9-29% of patients and 24-45% of physicians were unaware of MART, and among those who prescribed MART, 80-95% prescribed an additional (non-ICS) as-needed reliever. INTERPRETATION: Most physicians prioritized managing asthma symptoms over exacerbations. A lack of awareness and understanding of MART dosing exists among physicians. Practical strategies are required to implement GINA recommendations effectively in real-world clinical practice and to identify appropriate patients for MART.

Improving the Management of COPD in Women.

COPD is a highly debilitating disease that represents a substantial and growing health burden in women. There is increasing evidence for sex-related differences in COPD risk, progression, and outcomes. However, the disease receives scant attention as a women's health issue. Thus, a multifaceted approach is required to address COPD in women, including greater awareness, minimization of risk, and further elucidation of the sex-specific factors (biological and cultural) that affect risk, disease progression, and treatment success. This article reviews the current literature on the topic and provides suggestions for achieving better outcomes for the millions of women with COPD worldwide.

The COPD Assessment Test: Can It Discriminate Across COPD Subpopulations?

BACKGROUND: The COPD Assessment Test (CAT) is a valid disease-specific questionnaire measuring health status. However, knowledge concerning its use regarding patient and disease characteristics remains limited. Our main objective was to assess the degree to which the CAT score varies and can discriminate between specific patient population groups. METHODS: The Canadian Cohort Obstructive Lung Disease (CanCOLD) is a random-sampled, population-based, multicenter, prospective cohort that includes subjects with COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] classifications 1 to 3). The CAT questionnaire was administered at three visits (baseline, 1.5 years, and 3 years). The CAT total score was determined for sex, age groups, smoking status, GOLD classification, exacerbations, and comorbidities. RESULTS: A total of 716 subjects with COPD were included in the analysis. The majority of subjects (72.5%) were not previously diagnosed with COPD. The mean FEV1/FVC ratio was 61.1 ± 8.1%, with a mean FEV1 % predicted of 82.3 ± 19.3%. The mean CAT scores were 5.8 ± 5.0, 9.6 ± 6.7, and 16.1 ± 10.0 for GOLD 1, 2, and 3+ classifications, respectively. Higher CAT scores were observed in women, current smokers, ever-smokers, and subjects with a previous diagnosis of COPD. The CAT was also able to distinguish between subjects who experience exacerbations vs those who had no exacerbation. CONCLUSIONS: These results suggest that the CAT, originally designed for use in clinically symptomatic patients with COPD, can also be used in individuals with mild airflow obstruction and newly diagnosed COPD. In addition, the CAT was able to discriminate between sexes and subjects who experience frequent and infrequent exacerbations. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00920348; Study ID No.: IRO-93326.

Undiagnosed Chronic Obstructive Pulmonary Disease Contributes to the Burden of Health Care Use. Data from the CanCOLD Study.

RATIONALE: Chronic obstructive pulmonary disease (COPD) remains undiagnosed in many individuals with persistent airflow limitation. These individuals may be susceptible to exacerbation-like respiratory events that consume health care resources. OBJECTIVES: To compare exacerbation-like respiratory events, event prevalence, and differences in the odds of using medication and/or health services between subjects with diagnosed and undiagnosed COPD. METHODS: Subjects sampled from the general population participating in the CanCOLD (Canadian Cohort Obstructive Lung Disease) study, with at least 12 months of exacerbation-event follow-up who were classified as having physician-diagnosed or undiagnosed COPD were assessed. Exacerbation-like respiratory events were captured using a questionnaire administered every 3 months. MEASUREMENTS AND MAIN RESULTS: A total of 355 subjects were undiagnosed and 150 were diagnosed with COPD. Undiagnosed subjects were less symptomatic and functionally impaired, had been prescribed fewer respiratory medications, and had better health status. The incidence of reported exacerbation-like events was higher in diagnosed subjects and increased in both groups with the severity of airflow obstruction. Although subjects with diagnosed COPD were more often prescribed medication for exacerbation events, health service use for exacerbation events was similar in both groups. CONCLUSIONS: Most subjects with COPD in Canada remain undiagnosed. These subjects are less symptomatic and impaired, which may partly explain lack of diagnosis. Although patients with undiagnosed COPD experience fewer exacerbations than those with diagnosed COPD, they use a similar amount of health services for exacerbation events; thus, the overall health system burden of exacerbations in those with undiagnosed COPD is considerable.

Seretide: a pharmacoeconomic analysis.

BACKGROUND: The costs of asthma and chronic obstructive pulmonary disease (COPD), the two most common chronic respiratory illnesses, are substantial and rising. The fixed-dose combination of fluticasone and salmeterol has been a safe and effective therapy for these diseases. OBJECTIVES: To review the pharmacoeconomic impact of the fixed-dose combination of inhaled fluticasone and salmeterol in asthma and COPD. METHODS: A systematic review of the literature was carried out to identify pharmacoeconomic studies with fixed-dose salmeterol and fluticasone (Seretide, Advair, Viani). In addition, abstracts from recent respiratory meetings were sought, and any unpublished data were requested from the manufacturer. RESULTS: For asthma, when compared to treatment with inhaled corticosteroid monotherapy and antileukotrienes, alone or combined, salmeterol/fluticasone inhalation produced a higher proportion of successfully treated weeks, improvement in lung function and quality of life, and fewer treatment failures. The costs per quality-adjusted life year (QALY) for fluticasone/salmeterol have been favourable not only in patients with moderate to severe disease but also in patients with mild disease or patients not previously treated with a maintenance therapy. The excess cost per QALY varied from US$2,670 to US$26,445. For COPD, a clear reduction in exacerbation rates and improvement in quality of life has been demonstrated with salmeterol/fluticasone along with a likely improvement in survival rates. The incremental cost per QALY ratio for fluticasone/salmeterol against placebo ranged from US$9,512 to US$64,038. CONCLUSIONS: The data currently available suggest that the cost effectiveness of combination therapy with fluticasone and salmeterol is favourable for asthma and COPD in a variety of clinical settings.

The role of omalizumab in the treatment of severe allergic asthma.

BACKGROUND: A novel anti-immunoglobulin E (anti-IgE) therapy for asthma, omalizumab, has been approved for use in Canada. OBJECTIVE: To review the basic and clinical data for omalizumab, and to examine its possible role for asthma management in Canada. METHODS: A literature search from 1960 to 2006 was conducted in MEDLINE to identify studies of omalizumab. In addition, abstracts from recent respiratory and allergy scientific meetings were sought, and any unpublished data were requested from the manufacturer. A consensus panel of respiratory and allergy specialists reviewed and summarized the data, and derived a set of recommendations for omalizumab use. RESULTS: Omalizumab is a humanized monoclonal antibody designed to bind to the C epsilon 3 domain of the IgE molecule, forming soluble immune complexes that are cleared by the reticuloendothelial system. Subcutaneous injections, given at two- or four-week intervals at the recommended dose, result in a rapid decrease in free circulating IgE levels. In two phase III clinical trials of 1405 adult and adolescent patients with moderate to severe asthma maintained on moderate doses of inhaled corticosteroids (ICS), omalizumab reduced exacerbation rates compared with placebo, and was associated with improved symptoms and a greater corticosteroid-sparing effect. In a trial of 419 patients with severe disease that was uncontrolled despite the use of high-dose ICS and concurrent long-acting beta2-agonists, severe exacerbations were 50% less frequent in omalizumab-treated patients than in control subjects. Retrospective analyses have identified the characteristics of patients most likely to respond to omalizumab treatment. RECOMMENDATIONS: Omalizumab may be considered as a potential adjunctive therapy in atopic patients with severe asthma uncontrolled by conventional therapy with optimal doses of ICS and appropriate adjunctive therapy (eg, long-acting beta2-agonists). Typically, patients are identified by the need for frequent short course or continuous oral corticosteroids. Therapy should be initiated only after review by a specialist to confirm the diagnosis and that conventional therapy is optimal.

Evaluation of a questionnaire to assess compliance with anti-asthma medications.

Compliance with anti-asthma medication is essential in controlling symptoms and exacerbations in patients with asthma. Unfortunately, not all patients adhere to their treatment regimen, and it is difficult for clinicians to estimate a patient's compliance, since there is no simple and accurate method currently available to assist in its assessment. The objective of this study was to assess the validity and accuracy of utilizing clinical information regarding a patient's prescription refill frequency, inhaler emptying rate, reported forgetfulness, and short-acting bronchodilator usage to predict daily, anti-inflammatory intake. A questionnaire based on the clinical information described above was administered verbally to asthma patients with varying disease severities. Patient responses were compared to the patient's own pharmacy records. Questions that correlated significantly with pharmacy records were subsequently fit into a multiple regression model. Out of 147 eligible participants, 70 completed the questionnaire and had comprehensive pharmacy data available. There was a significant correlation between daily anti-inflammatory intake as estimated by pharmacy records and daily anti-inflammatory intake as determined by inhaler emptying rate (p<0.05), reported forgetfulness (p<0.05), and short-acting bronchodilator usage (p<0.05). These items were fit into a multiple regression model, which was predictive of daily anti-inflammatory intake as determined by pharmacy records. The sensitivity and specificity of our regression model in detecting non-compliance was 44% and 86%, respectively. We conclude that by inquiring into a patient's inhaler emptying rate, reported forgetfulness, and short-acting bronchodilator usage, a clinician may be able to more accurately estimate a patient's daily intake of anti-inflammatory medication.

The impact of budesonide and other inhaled corticosteroid therapies in the management of asthma in children and adults.

BACKGROUND: Since the recognition that asthma is characterized by extensive inflammation of the airways, the use of inhaled corticosteroids (ICSs) as controller therapy has become central to successful disease management. As the prevalence of asthma increases worldwide, there is concern about increasing numbers of patients with untreated or undertreated asthma, which may lead to deterioration in disease control, with direct effects on morbidity and mortality rates. The costs attributed to asthma translate into a considerable economic burden, from the direct costs of medical treatment to the costs incurred through lost work or school days. International treatment guidelines currently recommend early intervention with ICS therapy to improve lung function and disease control. OBJECTIVE: This article reviews the role of therapy with ICSs, particularly budesonide, in improving the management of asthma in patients of all ages and in reducing the economic and social burdens of this disease. RESULTS: Randomized, controlled clinical studies confirm the efficacy of early intervention with ICSs in patients with mild persistent asthma. Regular use of an ICS can reduce the number of exacerbations and hospitalizations in patients of all ages and with all disease severities. CONCLUSIONS: Budesonide has a well-established efficacy and safety profile. Its once-daily dosing may contribute to improved adherence and cost-effectiveness.

Economic issues in the use of office spirometry for lung health assessment.

The National Lung Health Education Program (United States) has recently recommended using office spirometry to screen for subclinical lung disease in adult smokers. No published studies evaluate the economic consequences of this recommendation. This review article outlines the issues that must be considered when evaluating the costs and health benefits of office spirometry. Much of the available data on the effectiveness of screening is from studies that included smoking cessation interventions, making it difficult to determine the effects of screening alone. The sensitivity and specificity of screening spirometry are not known, but may not be important in the economic model, because even false positive test results are beneficial if they lead to smoking cessation. Costs to be considered include those of spirometry itself, of implementing and maintaining screening and smoking cessation programs, and of their consequences, ie, reduced morbidity (lower short term health care costs) and mortality (perhaps higher long term health care costs). Despite these unique challenges, data are available to perform economic analyses regarding screening spirometry. Such analyses should play a role in future clinical policy making. Even modest quit rates attributable to screening spirometry may result in highly favourable cost effectiveness ratios.

Seretide for obstructive lung disease.

Seretide (Advair [North America], GlaxoSmithKline) is an inhaler combination formulation intended for the maintenance therapy of obstructive airways disease. Seretide was developed and made available initially as three multi-dose, dry powder inhaler formulations delivering 50 microg/puff of the long acting beta(2) agonist salmeterol and either 100, 250 or 500 microg/puff of the inhaled corticosteroid fluticasone propionate. In addition to the initial multi-dose dry powder inhaler system (Diskus or Accuhaler), a chlorofluorocarbon (CFC)-free pressurised aerosol formulation has become available. Studied mostly extensively as a maintenance therapy for patients with persistent asthma, the combination inhaler is at least equivalent to its components administered separately and is superior to monotherapy with salmeterol or inhaled corticosteroid in both paediatric and adult populations. The combination has a logical role in the treatment of moderate-to-severe asthma, offering the advantage of increased convenience and possibly improved compliance. In addition to improvements in lung function, symptom scores and quality of life, the combination therapy reduces exacerbation rates, an outcome that contributes to favourable cost-effectiveness. A role as initial maintenance therapy in all forms of persistent asthma is also plausible but there are fewer data concerning the impact of Seretide in milder forms of persistent asthma. Clinical trials are underway to examine the potential role of Seretide in patients with chronic obstructive pulmonary disease (COPD). Salmeterol has been shown to be an effective first-line bronchodilator in COPD and fluticasone has been shown to reduce the frequency and or severity of exacerbations in COPD patients in two key trials. At a time when the prevalence of both asthma and COPD is increasing, Seretide is a valuable step in the management of these common obstructive lung diseases.

Assessment of a medication-based asthma index for population research.

Asthma management guidelines recommend the use of preventive medications in sufficient amounts to control asthma symptoms. The validity of a medication use index as a proxy for asthma severity has not been established. We recruited 1,279 Ontario adults with asthma or parents of children with asthma from a community-based surveillance program in 1995-96. Participants completed a telephone questionnaire at baseline, 3 and 6 mo. The questionnaire gathered information about asthma medication use, health care utilization, and symptoms. Asthma was classified as mild in 28%, moderate in 49%, or severe in 23% of patients based on the amount and types of medication used. There were significant differences among groups in health resource use such that adults with higher medication use visited primary care physicians and specialists more frequently, had pulmonary functions tests more frequently, and were admitted to hospital more frequently. The findings among children were similar. There were weak positive correlations between medication use and symptom frequency in adults and children. We conclude that a medication use index may be useful in population-based research where clinical asthma severity data are lacking. Such an index is distinct from but is related to disease control.