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.

Objective: To evaluate the impact of asthma on patients in Brazil, by age group (12-17 years, 18-40 years, and ≥ 41 years). Methods: From a survey conducted in Latin America in 2011, we obtained data on 400 patients diagnosed with asthma and residing in one of four Brazilian state capitals (São Paulo, Rio de Janeiro, Curitiba, and Salvador). The data had been collected using a standardized questionnaire in face-to-face interviews. For the patients who were minors, the parents/guardians had completed the questionnaire. The questions addressed asthma control, number of hospitalizations, number of emergency room visits, and school/work absenteeism, as well as the impact of asthma on the quality of life, sleep, and leisure. We stratified the data by the selected age groups. Results: The proportions of patients who responded in the affirmative to the following questions were significantly higher in the 12- to 17-year age group than in the other two groups: "Have you had at least one episode of severe asthma that prevented you from playing/exercising in the last 12 months?" (p = 0.012); "Have you been absent from school/work in the last 12 months?" (p < 0.001); "Have you discontinued your asthma relief or control medication in the last 12 months?" (p = 0.008). In addition, 30.2% of the patients in the 12- to 17-year age group reported that normal physical exertion was very limiting (p = 0.010 vs. the other groups), whereas 14% of the patients in the ≥ 41-year age group described social activities as very limiting (p = 0.011 vs. the other groups). Conclusions: In this sample, asthma had a greater impact on the patients between 12 and 17 years of age, which might be attributable to poor treatment compliance.

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.

OBJECTIVE: To evaluate the impact of asthma, by gender, in a population sample of asthma patients in Brazil. METHODS: We conducted face-to-face interviews with 400 subjects (> 12 years of age) included in a national probability telephone sample of asthma patients in the Brazilian state capitals of São Paulo, Rio de Janeiro, Curitiba, and Salvador. Each of those 400 subjects completed a 53-item questionnaire that addressed five asthma domains: symptoms; impact of asthma on quality of life; perception of asthma control; exacerbations; and treatment/medication. RESULTS: Of the 400 patients interviewed, 272 (68%) were female. In relation to respiratory symptoms, the proportion of women reporting extremely bothersome symptoms (cough with sputum, tightness in the chest, cough/shortness of breath/tightness in the chest during exercise, nocturnal shortness of breath, and nocturnal cough) was greater than was that of men. Daytime symptoms, such as cough, shortness of breath, wheezing, and tightness in the chest, were more common among women than among men. Women also more often reported that their asthma interfered with normal physical exertion, social activities, sleep, and life in general. Regarding the impact of asthma on quality of life, the proportion of subjects who reported that asthma caused them to feel that they had no control over their lives and affected the way that they felt about themselves was also greater among women than among men. CONCLUSIONS: Among women, asthma tends to be more symptomatic, as well as having a more pronounced effect on activities of daily living and on quality of life.

OBJECTIVE: To assess asthma patients in Brazil in terms of the level of asthma control, compliance with maintenance treatment, and the use of rescue medication. METHODS: We used data from a Latin American survey of a total of 400 asthma patients in four Brazilian state capitals, all of whom completed a questionnaire regarding asthma control and treatment. RESULTS: In that sample, the prevalence of asthma was 8.8%. Among the 400 patients studied, asthma was classified, in accordance with the Global Initiative for Asthma criteria, as controlled, partially controlled, and uncontrolled in 37 (9.3%), 226 (56.5%), and 137 (34.3%), respectively. In those three groups, the proportion of patients on maintenance therapy in the past four weeks was 5.4%, 19.9%, and 41.6%, respectively. The use of rescue medication was significantly more common in the uncontrolled asthma group (86.9%; p < 0.001). CONCLUSIONS: Our findings suggest that, in accordance with the established international criteria, asthma is uncontrolled in the vast majority of asthma patients in Brazil. Maintenance medications are still underutilized in Brazil, and patients with partially controlled or uncontrolled asthma are more likely to use rescue medications and oral corticosteroids.

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.

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.

OBJECTIVE: To evaluate the impact of asthma on activities of daily living and on health status in patients with controlled, partially controlled, or uncontrolled asthma in Brazil. METHODS: We used data related to 400 patients in four Brazilian cities (São Paulo, Rio de Janeiro, Salvador, and Curitiba), obtained in a survey conducted throughout Latin America in 2011. All study subjects were > 12 years of age and completed a standardized questionnaire in face-to-face interviews. The questions addressed asthma control, hospitalizations, emergency room visits, and school/work absenteeism, as well as the impact of asthma on the quality of life, sleep, and leisure. The level of asthma control was determined in accordance with the Global Initiative for Asthma criteria. RESULTS: Among the 400 respondents, asthma was controlled in 37 (9.3%), partially controlled in 226 (56.5%), and uncontrolled in 137 (34.2%). The numbers of patients with uncontrolled or partially controlled asthma who visited the emergency room, who were hospitalized, and who missed school/work were higher than were those of patients with controlled asthma (p = 0.001, p = 0.05, and p = 0.01, respectively). Among those with uncontrolled asthma, the impact of the disease on activities of daily living, sleep, social activities, and normal physical exertion was greater than it was among those with controlled or partially controlled asthma (p < 0.001). CONCLUSIONS: In Brazil, asthma treatment should be monitored more closely in order to increase treatment adherence and, consequently, the level of asthma control, which can improve patient quality of life and minimize the negative impact of the disease.

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 5 32) and 27.3% per hour for placebo-treated patients (n 5 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. (J Allergy Clin Immunol 2011;127:398-405.)

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. (J Allergy Clin Immunol 2011;128:S4-24.)

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. Ann Allergy Asthma Immunol. 2010; 104: 471-477.

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.

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.

To the Editor: Optimally controlled asthma remains elusive in many children, as suggested by the high frequency of exacerbations requiring oral corticosteroid courses in those taking long-term controller medications. Although lower than the rate of 122 per 100 person-years in children taking placebo, children with mild-to-moderate asthma taking inhaled corticosteroids in the Childhood Asthma Management Program study demonstrated an oral corticosteroid–treated exacerbation rate of 70 per 100 person-years.1The Childhood Asthma Management Program Research GroupLong-term effects of budesonide or nedocromil in children with asthma.N Engl J Med. 2000; 343: 1054-1063Crossref PubMed Scopus (1313) Google Scholar Studies assessing rates of asthma exacerbations in children with severe or difficult-to-treat asthma are lacking. The goal of the current study was to compare the rates of asthma exacerbations, specifically overnight hospitalizations, emergency department (ED) visits, and oral corticosteroid courses, in children and adolescent or adult patients with severe or difficult-to-treat asthma who were taking recommended long-term controller asthma medications. The methods and baseline population characteristics of The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study have been previously described.2Dolan C.M. Fraher K.E. Bleecker E.R. Borish L. Chipps B. Hayden M.L. et al.TENOR Study Group. Design and baseline characteristics of The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study: a large cohort of patients with severe or difficult-to-treat asthma.Ann Allergy Asthma Immunol. 2004; 92: 32-39Abstract Full Text PDF PubMed Scopus (271) Google Scholar Briefly, TENOR was a prospective, observational, 3-year study conducted in the United States in patients with severe or difficult-to-treat asthma followed by asthma specialists. Study physicians subjectively categorized patients as having mild, moderate, or severe asthma. A patient was considered difficult to treat if the physician selected 1 or more of the following criteria at study entry: (1) complex treatment regimen, (2) multiple drugs required, (3) unable to avoid triggers, (4) frequent exacerbations, (5) severe exacerbations, and (6) unresponsive to therapy. Patients also had to have evidence of either high healthcare use (2 or more unscheduled care visits for asthma or 2 or more oral corticosteroid courses) or high medication use (currently requiring 3 medications to control asthma or long-term daily high doses of inhaled corticosteroids or use of 5 mg/d or more of oral prednisone), or both in the year before enrollment. No experimental intervention was involved; patients continued to receive asthma medications and treatments as recommended by their allergist or pulmonologist. At baseline, 4756 patients were enrolled at 283 study sites. A total of 224 children, ages 6 to 11 years, and 1726 adolescents and adults, ages ≥12 years, were evaluated in this analysis. Patients were included if they had no missing data at follow-up assessments for spirometry and asthma-related healthcare use. Parents or guardians and adult participants gave written informed consent. Data were collected at semiannual visits. Demographic, clinical, and medication data were collected by study coordinator interview and evaluation. Medication adherence was measured by using a proxy from the Asthma Therapy Assessment Questionnaire,3Skinner E.A. Diette G.B. Algatt-Bergstrom P.J. Nguyen T.T.H. Clark R.D. Markson L.E. et al.The Asthma Therapy Assessment Questionnaire (ATAQ) for children and adolescents.Disease Management. 2004; 7: 305-313Crossref PubMed Scopus (140) Google Scholar "What best describes how you take this medicine now?" Regular adherence was defined as "I take it every day" or "Some days I take it but other days I don't." Nonregular adherence was defined as "I used to take it but now I don't," "I only take it when I have symptoms," or "I never took it." Spirometry was measured annually according to American Thoracic Society guidelines, and sites were required to have a certified instrument calibrated daily. Predicted values were race-adjusted.4Hankinson J.L. Odencrantz J.R. Fedan K.B. Spirometric reference values from a sample of the general U.S. population.Am J Respir Crit Care Med. 1999; 159: 179-187Crossref PubMed Scopus (3432) Google Scholar For each age stratum, patients were categorized into 2 lung function strata on the basis of an Expert Panel Report (EPR)-3 guideline-defined normal (prebronchodilator percent predicted FEV1 > 80 %) or abnormal (prebronchodilator percent predicted FEV1 ≤ 80%) lung function at 2 consecutive assessments (baseline and month 12). Patients had to be in the same lung function stratum at baseline and month 12 to be included (patients who switched strata between the 2 assessments were excluded from analysis). At study entry and at each 12-month visit, patients reported asthma-related healthcare use during the previous 3 months. Asthma exacerbations at months 12, 18, and 24 were defined as either (1) an overnight hospitalization or ED visit in the previous 3 months or (2) an oral corticosteroid steroid burst in the previous 3 months. Descriptive statistics were generated for demographic and clinical variables at baseline. The frequency of asthma exacerbations was compared by age strata (6-11 years vs 12 years and older) and by lung function strata (>80% FEV1% predicted vs ≤80% FEV1% predicted). The Pearson χ2 test (or Fisher exact test for cell counts n <5) was used to compare data. A 2-sided P value of .05 was considered statistically significant. All analyses were conducted by using SAS (version 9.1; SAS Institute Inc, Cary, NC). Mean ± SD age (in years) was 9.6±1.4 in children and 50.3 ± 16.2 in adolescents or adults with FEV1 ≤ 80%, and 8.8 ± 1.7 in children and 40.9 ± 18.1 in adolescents or adults with FEV1 > 80%. Most patients were on 3 or more long-term controller asthma medications: 53% for children and 60% for adolescents or adults with FEV1 ≤ 80% (P = .43), and 63% for children and 57% for adolescents or adults with FEV1 > 80% (P = .19). In both normal and abnormal lung function strata, with the exception of month 12 for FEV1 ≤ 80%, the frequency of ED visits or overnight hospitalizations was significantly and clinically meaningfully higher (approximately 2-fold to 3-fold) in children than in adolescents or adults (Table I). At the 18-month and 24-month visits, nearly one fourth of children in the FEV1 ≤ 80% stratum had experienced an ED visit or hospitalization in the previous 3 months, compared with only about 8% to 9% of adolescents or adults. The frequency of ED visits or overnight hospitalizations was significantly higher among adolescents or adults with abnormal lung function than among those with normal lung function. The effect among children was of similar magnitude, but only marginally higher, probably because of reduced power (Table II).Table IFrequency of exacerbation outcomes in children age 6 to 11 years and adolescents and adults age 12 and older stratified by lung functionFEV1% predicted ≤80FEV1 % predicted >80Age 6-11 y (n = 34)Age 12+ y (n = 1081)P value∗P values compare differences between age groups.Age 6-11 y (n = 187)Age 12+ y (n = 645)P value∗P values compare differences between age groups.ED visit or hospitalization (%) 12 mo14.79.9.38†Derived from the Fisher exact test; other P values from the Pearson χ2 test.11.35.9.01 18 mo23.18.8.03†Derived from the Fisher exact test; other P values from the Pearson χ2 test.11.95.4.004 24 mo22.28.7.03†Derived from the Fisher exact test; other P values from the Pearson χ2 test.13.45.1.001Oral corticosteroid course (%) 12 mo41.236.4.5726.324.1.53 18 mo26.931.4.6222.821.8.80 24 mo51.930.7.0226.122.6.3912+, Adolescents/adults.∗ P values compare differences between age groups.† Derived from the Fisher exact test; other P values from the Pearson χ2 test. Open table in a new tab Table IIFrequency of exacerbation outcomes in lung function groups stratified by children age 6 to 11 years and adolescents and adults age 12 and olderAge 6-11 yAge 12+ yFEV1 % predicted ≤80 (n = 34)FEV1 % predicted >80 (n = 187)P value∗P values compare differences between lung function groups.FEV1 % predicted ≤80 (n = 1081)FEV1 % predicted >80 (n = 645)P value∗P values compare differences between lung function groups.ED visit or hospitalization (%) 12 mo14.711.3.57†Derived from the Fisher exact test; other P values from the Pearson χ2 test.9.95.9.004 18 mo23.111.9.13†Derived from the Fisher exact test; other P values from the Pearson χ2 test.8.85.4.01 24 mo22.213.4.24†Derived from the Fisher exact test; other P values from the Pearson χ2 test.8.75.1.02Oral corticosteroid course (%) 12 mo41.226.3.0836.424.1<.001 18 mo26.922.8.6431.421.8<.001 24 mo51.926.1.00730.722.6.00112+, Adolescents/adults.∗ P values compare differences between lung function groups.† Derived from the Fisher exact test; other P values from the Pearson χ2 test. Open table in a new tab 12+, Adolescents/adults. 12+, Adolescents/adults. The frequency of oral corticosteroid courses was comparably high in both age and lung function strata (Table I). In the FEV1 ≤ 80% stratum, approximately 30% to 40% of both children and adolescents or adults experienced an oral corticosteroid burst in the 3 months before the 12-month and 18-month visits. At month 24, more than half (52%) of children had received an oral corticosteroid burst in the previous 3 months, compared with 31% of adolescents and adults (P = .02). In the FEV1 > 80% stratum, about a fourth of children and adolescents or adults had received an oral corticosteroid burst in the 3 months before all visits. The frequency of oral corticosteroid courses was significantly higher in abnormal than in normal lung function in children at the 24-month time point and in adolescents or adults at all time points (Table II). There was no statistically significant difference between age or lung function strata with respect to medication adherence at baseline or month 12 follow-up. The majority of TENOR patients in our analysis (90% to 100%) were categorized as having regular adherence. Independent of lung function, we report 2-fold to 3-fold higher frequencies of severe asthma exacerbations in children compared with adolescents or adults with severe or difficult-to-treat asthma (Table I), despite treatment with standard long-term controller asthma medications. The frequency of patients requiring oral corticosteroid courses was similar in children and adolescents or adults, with the exception of the month 24 visit, at which the frequency was higher in children with FEV1 ≤ 80% than in adolescents or adults in this same stratum (Table I). In addition, the frequencies of severe exacerbations and oral corticosteroid courses were marginally to significantly higher in children at varying time points and significantly higher at all time points in adolescents or adults with lower lung function (Table II). These data indicate that asthma exacerbations are frequent in patients with severe or difficult-to-treat asthma, notwithstanding treatment with long-term asthma controllers, management by asthma specialists, and lung function above 80% predicted. Given the high incidence of severe exacerbations and oral corticosteroid courses in those with normal lung function, clinical impairment features in addition to lung function, as recommended by national guidelines, are needed to assess risk of asthma exacerbations in this normal lung function stratum of severe or difficult-to-treat asthma. Indeed, previous studies have shown that children with severe asthma, as determined by other outcomes, tend to have FEV1 values near predicted normal5Bacharier L.B. Strunk R.C. Mauger D. White D. Lemanske Jr., R.F. Sorkness C.A. Classifying asthma severity in children: mismatch between symptoms, medication use, and lung function.Am J Respir Crit Care Med. 2004; 170: 426-432Crossref PubMed Scopus (347) Google Scholar and demonstrate preserved pulmonary function.6Paull K. Covar R. Jain N. Gelfand E.W. Spahn J.D. Do NHLBI lung function criteria apply to children? a cross-sectional evaluation of childhood asthma at National Jewish Medical and Research Center, 1999-2002.Pediatr Pulmonol. 2005; 39: 311-317Crossref PubMed Scopus (83) Google Scholar In addition, in oral corticosteroid–dependent children, symptoms and episodic acute declines in lung function appear to precede chronic airflow limitation.7Jenkins H.A. Cherniack R. Szefler S.J. Covar R. Gelfand E.W. Spahn J.D. A comparison of the clinical characteristics of children and adults with severe asthma.Chest. 2003; 124: 1318-1324Crossref PubMed Scopus (125) Google Scholar Given the limited power in this study, however, additional studies of exacerbations by lung function are needed in children with severe or difficult-to-treat asthma. The similar-to-higher frequency of oral corticosteroid courses in children compared with adolescents and adults is of concern, given the potential for greater effects on growth of systemic corticosteroids in children.8Leone F.T. Fish J.E. Szefler S.J. West S.L. 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.Chest. 2003; 124: 2329-2340Crossref PubMed Scopus (114) Google Scholar Moreover, the higher frequency of severe asthma exacerbations requiring ED visits or hospitalizations despite similar to higher frequencies of oral corticosteroid use in children indicates greater limitations of systemic corticosteroids to prevent severe exacerbations in children compared with adults. Our findings demonstrate an unmet need in children with severe or difficult-to-treat asthma given the high frequency of severe asthma exacerbations despite asthma specialist–prescribed optimal controllers and acute intervention with oral corticosteroids and the potential for adverse effects from frequent oral steroid courses and high-dose inhaled corticosteroids.9Zöllner E.W. Hypothalamic-pituitary-adrenal axis suppression in asthmatic children on inhaled corticosteroids (Part 2)—the risk as determined by gold standard adrenal function tests: a systematic review.Pediatr Allergy Immunol. 2007; 18: 469-474Crossref PubMed Scopus (45) Google Scholar, 10Kelly H.W. Van Natta M.L. Covar R.A. Tonascia J. Green R.P. Strunk R.C. CAMP Research Group. Effect of long-term corticosteroid use on bone mineral density in children: a prospective longitudinal assessment in the childhood Asthma Management Program (CAMP) study.Pediatrics. 2008; 122: 53-61Crossref Scopus (146) Google Scholar As such, either better use of present interventions with improved objective adherence11Rand C. Bilderback A. Schiller K. Edelman J.M. Hustad C.M. Zeiger R.S. Adherence with montelukast or fluticasone in a long-term clinical trial: results from the mild asthma montelukast versus inhaled corticosteroid trial.J Allergy Clin Immunol. 2007; 119: 916-923Abstract Full Text Full Text PDF PubMed Scopus (76) Google Scholar, 12Strunk R.C. Bacharier L.B. Phillips B.R. Szefler S.J. Zeiger R.S. Chinchilli V.M. et al.Azithromycin or montelukast as inhaled corticosteroid-sparing agents in moderate-to-severe childhood asthma study.J Allergy Clin Immunol. 2008; 122: 1138-1144Abstract Full Text Full Text PDF PubMed Scopus (113) Google Scholar or new therapeutic modalities to reduce asthma-related healthcare use would be advantageous. We gratefully acknowledge Bryan Hains, PhD, of Genentech, Inc, who helped develop the first draft of this brief report with their assistance and extensive input.

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 m oderate-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. Anti Allergy Asthma Immunol. 2009;103:212-219.