Insights, attitudes and perceptions about asthma and its treatment: findings from a multinational survey of patients from 8 Asia-Pacific countries and Hong Kong.

BACKGROUND AND OBJECTIVE: The Asthma Insight and Management (AIM) survey was conducted in North America, Europe, the Asia-Pacific region and Latin America to characterize patients' insights, attitudes and perceptions about their asthma and its treatment. We report findings from the Asia-Pacific survey. METHODS: Asthma patients (≥12 years) from Australia, China, Hong Kong, India, Malaysia, Singapore, South Korea, Taiwan and Thailand were surveyed. Patients answered 53 questions exploring general health, diagnosis/history, symptoms, exacerbations, patient burden, disease management, medications/treatments and patient's attitudes. The Global Initiative for Asthma guidelines were used to assess asthma control. The survey was conducted by random digit telephone dialling (Australia, China and Hong Kong) or by random face-to-face interviews (India, Malaysia, Singapore, South Korea, Taiwan and Thailand). RESULTS: There were 80 761 households screened. Data from 3630 patients were collected. Wide disparity existed between objective measures of control and patient perception. Reported exacerbations during the previous year ranged from 19% (Hong Kong) to 67% (India). Reported unscheduled urgent/emergency visits to a doctor's office/hospital/clinic in the previous year ranged from 15% (Hong Kong) to 46% (Taiwan). Patients who reported having controlled asthma in the previous month ranged from 27% (South Korea) to 84% (Taiwan). Substantial functional and emotional limitations due to asthma were identified by 13% (South Korea) to 78% (India) of patients. CONCLUSIONS: Asthma has a profound impact on patients' well-being despite the availability of effective treatments and evidence-based management guidelines. Substantial differences across the surveyed countries exist, suggesting unmet, country-specific cultural and educational needs. A large proportion of asthma patients overestimate their level of control.

Practice patterns for oral corticosteroid burst therapy in the outpatient management of acute asthma exacerbations.

The use of a short course of oral corticosteroids (OCS), or "steroid burst," is standard practice in the outpatient management of acute severe exacerbations of asthma. Despite published guidelines, the actual practice patterns are unknown. A Web-based survey about typical patterns of OCS administration and total steroid burst dose was administered to pulmonologists (n = 150), allergists (n = 150), primary care physicians (n = 153), and pediatricians (n = 150). No predominant dosing regimen was observed, although a fixed single daily dose was the most commonly prescribed regimen (59%). The majority of physicians treating patients ≥12 years of age prescribed a total burst dose of ≤200 mg and essentially all (99.7%) prescribed ≤600 mg. Among physicians treating younger children, approximately one-quarter prescribed ≤1 mg/kg per day for 3 days (27.8% for children aged 5-11 years of age and 28.1% for children aged <5 years, respectively) and essentially all prescribed ≤2 mg/kg per day for 10 days (99.8% for children aged 5-11 years and 100% for children aged <5 years of age). When prescribing OCS burst therapy for asthma exacerbations, physicians tend to prescribe less than the upper dose recommended in the guidelines; with many physicians prescribing a total steroid burst dose below the lower end of the recommended dose range. Additional study is needed to determine the optimal dose and duration for treating exacerbations of asthma with OCS to minimize both side effects and time to reestablishing asthma control.

Effects of omalizumab on changes in pulmonary function induced by controlled cat room challenge.

BACKGROUND: Environmental exposure to cat allergen is common, and sensitization to cat allergens is strongly associated with asthma. OBJECTIVE: We sought to examine the efficacy of omalizumab in preventing acute bronchoconstriction induced by environmental exposure to cat allergen. METHODS: Patients with a history of cat allergen-induced asthma were randomized to treatment with omalizumab or placebo and exposed to cat allergen in a controlled chamber for up to 1 hour at baseline and after 16 weeks of treatment. The primary efficacy outcome was area under the curve for percentage decrease from prechallenge FEV(1) at week 16 for omalizumab-treated versus placebo-treated patients. FEV(1) was recorded before and every 10 minutes during the 1-hour challenge. Chest, nasal, and ocular symptoms were also monitored during cat chamber exposure as secondary end points. RESULTS: The area under the curve for percentage decrease in FEV(1) was 15.2% per hour for omalizumab-treated patients (n = 32) and 27.3% per hour for placebo-treated patients (n = 33), reflecting 44% less reduction in FEV(1) and a treatment difference of -12.1% per hour (P = .0009; 95% CI, -19.0 to -5.2). Compared with placebo-treated patients, omalizumab-treated patients were also able to tolerate longer allergen exposure (P = .0006) and demonstrated significant reductions from prechallenge values in their chest symptom score (P < .0001) and nasal-ocular symptom score (P = .0002). CONCLUSIONS: The severity of acute airway reactions and symptoms caused by controlled cat room exposure to allergens was significantly reduced by treatment with omalizumab.

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.

Economic burden of impairment in children with severe or difficult-to-treat asthma.

BACKGROUND: The cost associated with asthma impairment in children with severe asthma has not been determined. OBJECTIVE: To assess the asthma cost burden in children with severe or difficult-to-treat asthma based on asthma impairment. METHODS: Children aged 6 to 12 years in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens study with available data at baseline (n = 628), month 12 (n = 385), and month 24 (n = 280) corresponding to the National Heart, Lung, and Blood Institute asthma guidelines' impairment domain were included. Children were categorized as either very poorly controlled (VPC), not well controlled (NWC), or well controlled (WC) and assessed cross-sectionally and longitudinally. Mean total asthma costs based on direct (medication usage, unscheduled office visits, emergency department visits, hospitalizations) and indirect (school/work days lost) asthma costs were assessed. RESULTS: Mean annual total asthma costs were more than twice as high in the VPC group compared with NWC and WC groups (baseline: $7,846, $3,526, $3,766.44, respectively; month 12: $7,326, $2,959, $2,043, respectively; month 24: $8,879, $3,308, $1,861, respectively (all P < .001). Indirect costs accounted for approximately half the total asthma costs for VPC asthma patients at each time point. Significantly lower costs were observed for patients whose impairment status improved or temporarily improved from VPC after baseline. CONCLUSION: The economic burden of severe or difficult-to-treat asthma in children is associated with VPC asthma and improvement in asthma control and is associated with reducing cost. Further attention to patients with poorly controlled asthma, through better management strategies or more effective medications, may significantly reduce this burden of illness.

Consistently very poorly controlled asthma, as defined by the impairment domain of the Expert Panel Report 3 guidelines, increases risk for future severe asthma exacerbations in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study.

BACKGROUND: Identification of patients at risk for asthma exacerbations can assist physicians in addressing disease management and improve asthma-related health outcomes. OBJECTIVE: We sought to evaluate whether level of impairment, as defined by the 2007 asthma guidelines, predicts risk for future asthma exacerbations. METHODS: The study included children aged 6 to 11 years (n = 82) and adolescent/adult patients aged 12 years and older (n = 725) from The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens study with data representing all components of the impairment domain of the asthma guidelines at baseline, month 12, and month 24. Patients were categorized into 2 cohorts: (1) consistently very poorly controlled (VPC) asthma from baseline through 2 years of follow-up and (2) improved from VPC asthma at baseline (including patients who improved to not well-controlled or well-controlled asthma), with improvement maintained through 2 years of follow-up. Odds ratios (ORs) and 95% CIs for risk of asthma exacerbations at month 30 were generated by using multivariable logistic regression by age group. RESULTS: After adjustment, children with consistently VPC asthma over the 2-year period demonstrated a 6-fold increased risk of hospitalization, emergency department visit, or corticosteroid burst (OR, 6.4; 95% CI, 1.2-34.5) compared with the improved group. Adolescent/adult patients with consistently VPC asthma were more likely to have a corticosteroid burst (OR, 2.8; 95% CI, 1.7-4.8) or have a hospitalization, emergency department visit, or corticosteroid burst (OR, 3.2; 95% CI, 1.9-5.3). CONCLUSIONS: Consistently VPC asthma, as defined by the impairment domain of the 2007 asthma guidelines, is strongly predictive of future asthma exacerbations.

Recent asthma exacerbations predict future exacerbations in children with severe or difficult-to-treat asthma.

BACKGROUND: Children with severe/difficult-to-treat asthma experience high morbidity including frequent severe exacerbations. More knowledge is required to identify predictors of these exacerbations to reduce their occurrence. OBJECTIVE: To investigate the risk of future severe exacerbations (FSEs) in children with severe/difficult-to-treat asthma and recent severe exacerbations (RSEs). METHODS: We analyzed the occurrence and association of RSE (defined as 1 or more corticosteroid bursts during the 3 months before each of 3 annual visits) and FSE (defined as 1 or more corticosteroid bursts 6 or 12 months later) in children age 6 to 11 years in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens 3-year observational study. Repeated measures logistic regression analysis assessed the risk of FSE adjusted for demographics and clinical variables. RESULTS: In a multivariable model, FSE at 6 months was most strongly predicted by RSE (odds ratio [OR], 3.08; 95% CI, 2.21-4.28) and having 3 to 4 allergic triggers (OR, 2.05; 95% CI, 1.31-3.20). Race (OR, 1.77; 95% CI, 1.25-2.51) and being very poorly controlled according to the impairment component of the National Heart, Lung, and Blood Institute guidelines (OR, 1.59; 95% CI, 1.14-2.23) also significantly predicted FSE. CONCLUSION: Recent severe asthma exacerbations are an important independent predictor of FSE in children with severe/difficult-to-treat asthma and should be considered when establishing asthma management plans.

Daily versus as-needed corticosteroids for mild persistent asthma.

BACKGROUND: Although guidelines recommend daily therapy for patients with mild persistent asthma, prescription patterns suggest that most such patients use these so-called controller therapies intermittently. In patients with mild persistent asthma, we evaluated the efficacy of intermittent short-course corticosteroid treatment guided by a symptom-based action plan alone or in addition to daily treatment with either inhaled budesonide or oral zafirlukast over a one-year period. METHODS: In a double-blind trial, 225 adults underwent randomization. The primary outcome was morning peak expiratory flow (PEF). Other outcomes included the forced expiratory volume in one second (FEV1) before and after bronchodilator treatment, the frequency of exacerbations, the degree of asthma control, the number of symptom-free days, and the quality of life. RESULTS: The three treatments produced similar increases in morning PEF (7.1 to 8.3 percent; approximately 32 liters per minute; P=0.90) and similar rates of asthma exacerbations (P=0.24), even though the intermittent-treatment group took budesonide, on average, for only 0.5 week of the year. As compared with intermittent therapy or daily zafirlukast therapy, daily budesonide therapy produced greater improvements in pre-bronchodilator FEV1 (P=0.005), bronchial reactivity (P<0.001), the percentage of eosinophils in sputum (P=0.007), exhaled nitric oxide levels (P=0.006), scores for asthma control (P<0.001), and the number of symptom-free days (P=0.03), but not in post-bronchodilator FEV1 (P=0.29) or in the quality of life (P=0.18). Daily zafirlukast therapy did not differ significantly from intermittent treatment in any outcome measured. CONCLUSIONS: It may be possible to treat mild persistent asthma with short, intermittent courses of inhaled or oral corticosteroids taken when symptoms worsen. Further studies are required to determine whether this novel approach to treatment should be recommended.

Inhaled mometasone furoate reduces oral prednisone usage and improves lung function in severe persistent asthma.

OBJECTIVE: The reduction of oral prednisone use by mometasone furoate (MF) delivered by HFA-227 metered dose inhaler (MDI) was examined in oral corticosteroid (OCS)-dependent patients with severe persistent asthma. METHODS: A 3-month, double-blind, placebo-controlled clinical trial (n=123), followed by a 9-month open-label phase (n=120). The study was conducted at 26 medical centers in the United States. Patients were randomized to treatment with MF-MDI 400 or 800 microg twice-daily (bid) doses, or placebo in the double-blind trial. All patients received MF in the open-label phase. RESULTS: At the endpoint of the double-blind trial, MF-MDI 400 and 800 microg bid reduced the daily OCS dose by 39.4% and 31.1%, respectively, while placebo increased the OCS dose by 107.2% (P<0.01). The OCS requirement was reduced by 50% or more in 63% and 60% of patients treated with MF-MDI 400 and 800 microg bid, respectively, compared with 14% of patients receiving placebo. After 12 weeks, despite prednisone reductions, pulmonary function, asthma symptoms, albuterol use, nocturnal awakenings, and physician-evaluated response to therapy also showed significant improvement with MF-MDI treatment compared with placebo. Further reductions in OCS requirements were achieved with long-term MF-MDI treatment in the open-label phase, with an overall 67% reduction in prednisone usage and 51% of patients completely eliminating prednisone usage by the 1-year time point. CONCLUSION: MF delivered by HFA-227 MDI significantly reduces daily OCS use compared with placebo and facilitates elimination of OCS use in patients with severe persistent asthma.

Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada.

BACKGROUND: Asthma surveys completed within the past 10 years in the Americas and the Asia-Pacific region have shown significant underassessment of asthma severity in addition to undertreatment of asthma and have suggested the need to improve long-term asthma management. In this study, we examined the frequency of asthma symptoms and severe episodes, patients' perceived asthma control, and use of asthma medications in Europe and Canada. METHODS: The Asthma Insight and Management survey (54 questions) was conducted in Europe (Germany, Italy, Spain and the United Kingdom) and Canada from June 14 through July 28, 2010. Telephone interviews were conducted with randomly screened patients or parents of adolescents (aged 12-17 years) with asthma; patients younger than 12 years of age were excluded from the survey. Responses were reported separately for each country and in total for all five countries. RESULTS: Seventy-five thousand three hundered thirty-five households were screened, and 2003 patients were interviewed. The survey respondents represented a wide range of severity. Overall, 26 % of patients reported symptoms daily or most days over the past 4 weeks, but most patients (81 %) perceived their asthma to be well or completely controlled. Over the past year, 41 % of patients had episodes of frequent/severe symptoms, and 50 % reported acute treatment (e.g. hospitalization, emergency visit, unscheduled physician visit) for asthma. Across countries, 52 % of patients reported taking controller medication every day over the past year, 27 % reported not taking any controller medication, and 14 % reported stopping controller treatment for 3 months or longer the last time they stopped. Many patients considered asthma well controlled if each year they had only two urgent doctor visits (50 %), three or four exacerbations (60 %), and/or one emergency room visit (41 %). DISCUSSION: This is the largest survey of patients with asthma in Europe and Canada in more than a decade. CONCLUSION: In 2010, many surveyed patients in Europe and Canada reported features indicating uncontrolled asthma, yet the majority believed they were well controlled, indicating that they had low expectations of long-term asthma management. Use of controller medications was substantially less than recommended in treatment guidelines.

Taking Aim at Asthma Around the World: Global Results of the Asthma Insight and Management Survey in the Asia-Pacific Region, Latin America, Europe, Canada, and the United States.

BACKGROUND: Asthma, a worldwide health problem, can be controlled if properly diagnosed and managed. Multinational surveys conducted in patients with asthma from 1998 to 2003 indicated that asthma was inadequately controlled. The Asthma Insight and Management (AIM) study represents the largest survey conducted on patients with asthma since 2003. OBJECTIVE: The objective of this study was to assess findings from the United States (US), Europe and Canada (EUCAN), Latin America (LA), and the Asia-Pacific (AP) region surveys to identify differences and similarities with earlier surveys on patients with asthma. METHODS: The US, EUCAN, LA, and AP AIM surveys conducted from 2009 to 2011 all used a common set of questions. Responses to these are reported as proportions of patients with asthma for each country individually, and as totals for all regions. Results are presented as mean/median proportions for US, EUCAN, LA, and AP survey populations individually. Global medians and the range of regional response values are also described. RESULTS: A total of 10,302 patients or parents of adolescents with asthma were interviewed. Approximately one-quarter reported daytime symptoms daily or on most days over the previous 4 weeks. Globally, a median of 67% (range, 27%-88%) of patients perceived their asthma as completely and/or well controlled, but a median of only 9% (range, 0%-29%) of patients had well-controlled asthma using criteria from asthma guidelines. A majority (≥60%) of patients felt that quick-relief medication could be used daily if needed, contrary to guideline recommendations. CONCLUSIONS: Patients exhibited a lack of knowledge and conviction for treatment recommendations and guidelines that was relatively uniform across the regions, similar to earlier survey findings. These results reveal an ongoing need for improvement in asthma care and education in most populations.

Systematic review of the evidence regarding potential complications of inhaled corticosteroid use in asthma: collaboration of American College of Chest Physicians, American Academy of Allergy, Asthma, and Immunology, and American College of Allergy, Asthma, and Immunology.

INTRODUCTION: The available clinical guidelines have been successful in improving awareness of the inflammatory nature of asthma and have promoted the use of inhaled corticosteroids (ICSs) to achieve long-term control of symptoms. Because of lingering concerns over the possible adverse consequences of ICS use, an expert panel was convened with a mandate to identify the critical questions that impact decisions regarding the use of ICSs and to evaluate the available evidence with respect to risk. METHODS: A university librarian retrieved citations and abstracts from the MEDLINE and EMBASE databases using a list of National Library of Medicine search terms and key words. Reviewers were asked to systematically abstract relevant information from each of their assigned articles and to list their own clinical or scientific conclusions based on the study results. A predefined grading algorithm was used to calculate a summary quality rating score for the relevant evidence. RESULTS: The results are presented as a series of key questions followed by a summary of the relevant evidence. An evidence grade is assigned, followed by a summary statement reflecting the panel's consensus opinion following review. CONCLUSIONS: The preponderance of evidence supports a conclusion that the proven clinical effectiveness of ICS treatment decidedly outweighs the proven risks.

Insights, attitudes, and perceptions about asthma and its treatment: findings from a multinational survey of patients from Latin America.

BACKGROUND: In 2011 the Latin America Asthma Insight and Management (LA AIM) survey explored the realities of living with asthma. We investigated perception, knowledge, and attitudes related to asthma among Latin American asthma patients. METHODS: Asthma patients aged ≥12 years from four Latin American countries (Argentina, Brazil, Mexico, Venezuela) and the Commonwealth of Puerto Rico responded to questions during face-to-face interviews. A sample size of 2,169 patients (approximately 400 patients/location) provided an accurate representation of asthma patients' opinions. Questions probed respondents' views on topics such as levels of asthma control, frequency and duration of exacerbations, and current and recent use of asthma medications. RESULTS: A total of 2,169 adults or parents of children with asthma participated in the LA AIM survey. At least 20% of respondents experienced symptoms every day or night or most days or nights. Although 60% reported their disease as well or completely controlled, only 8% met guideline criteria for well-controlled asthma. 47% of respondents reported episodes when their asthma symptoms were more frequent or severe than normal, and 44% reported seeking acute care for asthma in the past year. Asthma patients in Latin America overestimated their degree of asthma control. CONCLUSIONS: The LA AIM survey demonstrated the discrepancy between patient perception of asthma control and guideline-mandated criteria. Additional education is required to teach patients that, by more closely following asthma management strategies outlined by current guidelines more patients can achieve adequate asthma control.

Asthma control and activity limitations: insights from the Real-world Evaluation of Asthma Control and Treatment (REACT) study.

BACKGROUND: Uncontrolled asthma remains prevalent in the United States and confers a substantial burden on the health care system. OBJECTIVES: To evaluate the association between uncontrolled asthma and activity limitations in a nationally representative sample of patients with moderate-to-severe-treated asthma and to assess the degree to which demographics and comorbidities were associated with activity limitations. METHODS: Patients who participated in the Real-world Evaluation of Asthma Control and Treatment study were surveyed regarding type and degree of activity limitations in 4 categories: outdoor activity, physical activity, daily activity, and environmental triggers. Information about asthma control, demographics, and comorbidities was collected. Multivariable regression was used to assess the association between uncontrolled asthma and activity limitations while adjusting for demographic characteristics and comorbid conditions. RESULTS: Uncontrolled asthma was associated with a greater than 2-fold risk of outdoor (odds ratio [OR], 2.58; 95% confidence interval [CI], 1.90-3.51) or physical (OR, 2.62; 95% CI, 1.90-3.61) activity limitations and a 66% increased risk of daily activity limitations (OR, 1.66; 95% CI, 1.09-2.51). Comorbidities associated with activity limitation included hives, chronic sinusitis, arthritis, gastroesophageal reflux disease, hypercholesterolemia, and depression. The observed associations between uncontrolled asthma and activity limitation remained significant after controlling for demographic characteristics and comorbid conditions. CONCLUSIONS: Compared with patients with controlled asthma, those with uncontrolled asthma are at higher risk for limitations in outdoor activity, physical activity, and daily activity. To help patients achieve optimal health, asthma management should include routine assessment of activity limitations and assessment and coordinated care for comorbid conditions.

Effect of weight change on asthma-related health outcomes in patients with severe or difficult-to-treat asthma.

OBJECTIVE: To evaluate the effects of weight change on asthma control, asthma-related quality of life, number of steroid bursts, and exacerbation of asthma symptoms in a population of adult patients with severe or difficult-to-treat asthma who participated in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. METHODS: We categorized 2396 TENOR patients > or = 18 years into three groups (> or = 5 lb loss, stable, > or = 5 lb gain), based on a +/-5 lb (2.27 kg) difference between baseline and 12-month follow-up weight. We used proportional odds and logistic regression models to evaluate the effect of weight change on Asthma Therapy Assessment Questionnaire (ATAQ) and Asthma Quality of Life Questionnaire (AQLQ) scores, exacerbations, and steroid bursts at the 12-month follow-up. RESULTS: Asthma patients who gained > or = 5 lb (2.27 kg) during the 12-month interval between baseline and follow-up reported poorer asthma control (adjusted odds ratio [OR]: 1.22; 95% confidence interval [CI]: 1.01-1.49; p=0.04), worse quality of life (least square means: -0.18; 95% CI: -0.30 to -0.06; p=0.003), and a greater number of steroid bursts (OR: 1.31; CI: 1.04-1.66; p=0.02) than patients who maintained their baseline weight or lost > or = 5 lb (2.27 kg). CONCLUSION: Increased weight is associated with worse asthma-related health outcomes. Strategies to prevent weight gain could help patients achieve better asthma control and improve asthma-related quality of life.

Predicting asthma control using patient attitudes toward medical care: the REACT score.

BACKGROUND: The association between patients' degree of asthma control and their attitudes toward medical professionals and asthma therapy is unknown. OBJECTIVE: To develop a tool, the REACT Score, that can be used by physicians to compute the risk of having uncontrolled asthma based on patient attitudes toward medical professionals and asthma treatment. METHODS: A nationally representative sample of adult patients (> or = 18 years old) with moderate to severe asthma completed the Asthma Control Test and were surveyed regarding their attitudes about relationships with medical professionals and asthma treatments. Competing predictive models were developed to determine the association between attitude questions and asthma control. Using the model with the highest c-index, a REACT Score was computed. RESULTS: The proportion of uncontrolled patients (Asthma Control Test score < 20) in the high-, medium-, and low-risk REACT Score categories was 75%, 50%, and 24%, respectively. Patients who believed that their physician recognized lifestyle compromises due to asthma, who were not satisfied with their treatment regimen, and who took asthma medication more frequently than prescribed had a higher risk of poor asthma control. CONCLUSION: The REACT Score is a novel way to predict asthma control and to identify key attitudes and behaviors that need to be addressed to engage a patient in ongoing, effective care. This tool may also improve communication between asthmatic patients and their physicians by identifying patient concerns regarding their treatment and quality of life.

Baseline characteristics of patients enrolled in EXCELS: a cohort study.

BACKGROUND: The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS) is a unique opportunity to evaluate the prospective, long-term clinical safety and effectiveness of the anti-IgE antibody omalizumab (Xolair) in real-world clinical practice. OBJECTIVES: To describe the study design and study cohorts of EXCELS at baseline and to compare the characteristics of this population with other large asthma cohorts. METHODS: Patients with moderate-to-severe persistent asthma and a positive skin test result or in vitro reactivity to a perennial aeroallergen were eligible for EXCELS. Two cohorts of patients with asthma were enrolled: those treated with omalizumab and those not treated with omalizumab. We analyzed baseline demographic and clinical characteristics, including asthma history and control and allergy history. RESULTS: Large proportions of patients enrolled in EXCELS had historically severe and poorly or not well-controlled asthma at the time of enrollment, objective evidence of airway obstruction, a history of long-term oral corticosteroid use, and/or other allergic disorders. Minor differences were observed between the omalizumab and nonomalizumab cohorts. Our total patient cohort was generally similar to other large cohorts. In a subgroup analysis, patients who had received omalizumab within 7 days before enrollment had more severe asthma and greater degrees of impairment at baseline than nonomalizumab patients. CONCLUSIONS: This study of baseline characteristics in EXCELS offers a unique opportunity to better understand the history of allergic patients with moderate-to-severe asthma in a real-world treatment setting. This analysis of EXCELS baseline data sets the foundation for long-term assessment of the safety and effectiveness of omalizumab.

Smoking affects response to inhaled corticosteroids or leukotriene receptor antagonists in asthma.

RATIONALE: One-quarter to one-third of individuals with asthma smoke, which may affect response to therapy and contribute to poor asthma control. OBJECTIVES: To determine if the response to an inhaled corticosteroid or a leukotriene receptor antagonist is attenuated in individuals with asthma who smoke. METHODS: In a multicenter, placebo-controlled, double-blind, double-dummy, crossover trial, 44 nonsmokers and 39 light smokers with mild asthma were assigned randomly to treatment twice daily with inhaled beclomethasone and once daily with oral montelukast. MEASUREMENTS AND MAIN RESULTS: Primary outcome was change in prebronchodilator FEV(1) in smokers versus nonsmokers. Secondary outcomes included peak flow, PC(20) methacholine, symptoms, quality of life, and markers of airway inflammation. Despite similar FEV(1), bronchodilator response, and sensitivity to methacholine at baseline, subjects with asthma who smoked had significantly more symptoms, worse quality of life, and lower daily peak flow than nonsmokers. Adherence to therapy did not differ significantly between smokers and nonsmokers, or between treatment arms. Beclomethasone significantly reduced sputum eosinophils and eosinophil cationic protein (ECP) in both smokers and nonsmokers, but increased FEV(1) (170 ml, p = 0.0003) only in nonsmokers. Montelukast significantly increased a.m. peak flow in smokers (12.6 L/min, p = 0.002), but not in nonsmokers. CONCLUSIONS: In subjects with mild asthma who smoke, the response to inhaled corticosteroids is attenuated, suggesting that adjustments to standard therapy may be required to attain asthma control. The greater improvement seen in some outcomes in smokers treated with montelukast suggests that leukotrienes may be important in this setting. Larger prospective studies are required to determine whether leukotriene modifiers can be recommended for managing asthma in patients who smoke.

Occupational asthma and rhinoconjunctivitis induced by natural rubber latex exposure.

A number of reports indicate that occupational exposure to natural rubber latex (NRL) in health care workers can elicit symptoms of rhinoconjunctivitis with or without asthma in selected individuals who are sensitized. The prevalence or risk of NRL-induced asthma in relation to rhinoconjunctivitis is small in comparison with other forms of occupational allergic respiratory disease. The lower risk of NRL-induced asthma appears to be related to poor penetration of the allergen into the lower respiratory tract because of the relatively large particle size of allergen-bearing cornstarch particles. Because of a lack of large prospective studies, little is know about the incidence and natural history of latex-induced respiratory disease. Because of heightened awareness of NRL allergy and changing patterns in glove manufacturing and glove use, it is likely that the occurrence of NRL-induced occupational respiratory disease will decline and its natural history will change. Nevertheless, because large number of individuals are exposed to NRL in various occupations, the incidence, prevalence, and natural history of NRL allergy merit further monitoring.