Incidence Of Asthma Exacerbations Research Articles

Impact of the COVID-19 Pandemic on Incidence of Asthma Exacerbations and Hospitalizations in US Subspecialist-Treated Patients with Severe Asthma: Results from the CHRONICLE Study.

PurposePatients with severe asthma (SA) are at an increased risk of asthma-related hospitalizations and exacerbations. Despite concerns that COVID-19 circulation would increase exacerbations of SA, anecdotal reports suggest that social distancing and exposure avoidance may have led to reduced exacerbations.Patients and methodsCHRONICLE is an ongoing noninterventional observational study of 3100 subspecialist-treated patients with SA. Eligible adults (≥ 18 years of age) have (1) current use of monoclonal antibody (ie, biologic) therapy for SA, (2) use of maintenance systemic corticosteroids (mSCS) or other systemic immunosuppressants for ≥ 50% of the prior 12 months for SA, or (3) persistently uncontrolled asthma while treated with high-dosage inhaled corticosteroids with additional controllers. For enrolled patients, electronic medical records were reviewed to record all exacerbations and asthma-related hospitalizations. Descriptive analyses were conducted of the monthly incidence of exacerbations, exacerbation-related visits to the emergency department (ED), and asthma hospitalizations from July 2018 through July 2021.ResultsExacerbations, exacerbation-related ED visits, and hospitalizations decreased since April 2020. Exacerbations in 2020 were 20% to 52% lower in April through August relative to the same months in 2019. Exacerbations remained lower than the prior year through May 2021. Similar results were observed by United States (US) census region, with an earlier decrease in exacerbation rates in the western US versus other regions. Across all months, exacerbation rates were lower among biologic recipients.ConclusionIn a clinical cohort of subspecialist-treated patients with SA, there was a meaningful reduction in exacerbations, exacerbation-related ED visits, and asthma hospitalizations following COVID-19–related stay-at-home orders and social distancing recommendations. Reasons for these reductions are likely multifactorial, including reduced viral infections due to less social contact and altered patient behavior.

Impact of mepolizumab in patients with high-burden severe asthma within a managed care population

Objective To evaluate the real-world impact of mepolizumab on the incidence of asthma exacerbations, oral corticosteroid (OCS) use and asthma exacerbation-related costs in patients with high-burden severe asthma. Methods This was a retrospective study of the MarketScan Commercial and Medicare Databases in patients with high-burden severe asthma (≥80th percentile of total healthcare expenditure and/or significant comorbidity burden). Patients were ≥12 years of age upon mepolizumab initiation (index date November 1, 2015–December 31, 2018) and had ≥2 mepolizumab administrations during the 6 months post-index. Asthma exacerbation frequency (primary outcome), use of OCS (secondary outcome), and asthma exacerbation-related costs (exploratory outcome) were assessed during the 12 months pre-index (baseline) and post-index (follow-up). Results In total, 281 patients were analyzed. Mepolizumab significantly reduced the proportion of patients with any asthma exacerbation (P < 0.001) or exacerbations requiring hospitalization (P = 0.004) in the follow-up versus baseline period. The mean number of exacerbations decreased from 2.5 to 1.5 events/patient/year (relative reduction: 40.0%; P < 0.001). The proportion of patients with ≥1 OCS claim also decreased significantly from 94.0% to 81.9% (relative reduction: 12.9%; P < 0.001), corresponding to a decrease from 6.6 to 4.7 claims/person/year (P < 0.001). Of the 264 patients with ≥1 OCS claim during baseline, 191 (72.3%) showed a decrease in mean daily OCS use by ≥50% in 117 patients (61.3%). Total asthma exacerbation-related costs were significantly lower after mepolizumab was initiated (P < 0.001). Conclusions Mepolizumab reduced exacerbation frequency, OCS use and asthma exacerbation-related costs in patients with high-cost severe asthma. Mepolizumab provides real-world benefits to patients, healthcare systems and payers.

Regional differences in the incidence of asthma exacerbations in Japan: A heat map analysis of healthcare insurance claims data

BackgroundIn Japan, regional differences in asthma mortality have been reported; however, regional differences in asthma exacerbations have not been studied extensively. Therefore, using a health insurance claims database, we investigated the regional differences in the incidence of asthma exacerbations in Japan. MethodsThis study used data from Medi-Scope (Japan Medical Information Research Institute Inc., Japan)—a nationwide health insurance claims database. Patients with asthma at the index date (the latest date of an asthma-related prescription with an asthma diagnosis before October 1, 2018) were included in the analysis. The pre-index period was defined as 1 year before the index date, and the follow-up period as 1 year after the index date. The incidence of asthma exacerbation events was analyzed for each region. ResultsThe primary analysis population comprised 24,883 patients who were continuously prescribed ICS or ICS/LABA at least four times during the pre-index period. The incidence rate of asthma exacerbations with hospitalization was the highest in Chugoku (2.95/100 person-years [95% CI, 1.97–4.43]) and the lowest in Kanto (1.52/100 person-years [95% CI, 1.26–1.83]). The incidence rate of asthma exacerbations for the composite outcome of hospitalization, injectable corticosteroid prescription, and oral corticosteroid burst was the highest in Fukui (105.00/100 person-years [95% CI, 64.53–170.85]) and the lowest in Nagasaki (15.69/100 person-years [95% CI, 10.84–22.72]). ConclusionsRegional differences in the incidence of asthma exacerbations as well as their treatments were observed in Japan.

Pharmacogenetics of inhaled corticosteroids and exacerbation risk in adults with asthma.

Inhaled corticosteroids (ICS) are a cornerstone of asthma treatment. However, their efficacy is characterized by wide variability in individual responses. We investigated the association between genetic variants and risk of exacerbations in adults with asthma and how this association is affected by ICS treatment. We investigated the pharmacogenetic effect of 10 single nucleotide polymorphisms (SNPs) selected from the literature, including SNPs previously associated with response to ICS (assessed by change in lung function or exacerbations) and novel asthma risk alleles involved in inflammatory pathways, within all adults with asthma from the Dutch population-based Rotterdam study with replication in the American GERA cohort. The interaction effects of the SNPs with ICS on the incidence of asthma exacerbations were assessed using hurdle models adjusting for age, sex, BMI, smoking and treatment step according to the GINA guidelines. Haplotype analyses were also conducted for the SNPs located on the same chromosome. rs242941 (CRHR1) homozygotes for the minor allele (A) showed a significant, replicated increased risk for frequent exacerbations (RR=6.11, P<0.005). In contrast, rs1134481 T allele within TBXT (chromosome 6, member of a family associated with embryonic lung development) showed better response with ICS. rs37973 G allele (GLCCI1) showed a significantly poorer response on ICS within the discovery cohort, which was also significant but in the opposite direction in the replication cohort. rs242941 in CRHR1 was associated with poor ICS response. Conversely, TBXT variants were associated with improved ICS response. These associations may reveal specific endotypes, potentially allowing prediction of exacerbation risk and ICS response.

Risk of wheezing and asthma exacerbation in children treated with paracetamol versus ibuprofen: a systematic review and meta-analysis of randomised controlled trials

BackgroundParacetamol and ibuprofen are the most commonly used medications for fever and pain management in children. While the efficacy appears similar with both drugs, there are contradictory findings related to adverse events. In particular, incidence of wheezing and asthma among children taking paracetamol compared to ibuprofen, remain unsettled.MethodsWe conducted a meta-analysis of randomized controlled trials (RCTs) that compared wheezing and asthma exacerbations in children taking paracetamol versus ibuprofen. A comprehensive search was conducted in five databases. RCTs reporting on cases of wheezing or asthma exacerbations in infants or children after the administration of paracetamol or ibuprofen were included. The pooled effect size was estimated using the Peto’s odds ratio.ResultsFive RCTs with 85,095 children were included in the analysis. The pooled estimate (OR 1.05; 95%CI 0.76–1.46) revealed no difference in the odds of developing asthma or presenting an exacerbation of asthma in children who received paracetamol compared to ibuprofen. When the analysis was restricted to RCTs that examined the incidence of asthma exacerbation or wheezing, the pooled estimate remained similar (OR 1.01; 95%CI 0.63–1.64). Additional bias adjusted quality effect sensitivity model yielded similar results (RR 1.03; 95%CI 0.84–1.28).ConclusionAlthough, Ibuprofen and paracetamol appear to have similar tolerance and safety profiles in terms of incidence of asthma exacerbations in children, we suggest high quality trials with clear definition of asthma outcomes after receiving ibuprofen or paracetamol at varying doses with longer follow-up are warranted for any conclusive finding.

Fractional exhaled nitric oxide and forced expiratory volume in 1 second/forced vital capacity have predictive value of asthma exacerbation in Korean school children.

BackgroundThe incidence of asthma exacerbation (AE) and the predictive value of spirometry and fractional exhaled nitric oxide (FeNO) in school children have not been evaluated.ObjectiveWe sought to evaluate the efficacy of spirometry measurement and FeNO monitoring for predicting AE in school children in the Cheongju area in Korea.MethodsWith parental agreement, we studied 170 students aged 7–12 years. Children were evaluated by an asthma specialist using baseline spirometry, skin prick test, seasonal FeNO measurement, and asthma control test. The study participants underwent a physical examination and their medical history was also evaluated by the specialist. They were assessed for asthma control status during regular doctor visits for 1 year.ResultsIn total, 160 children (94.1%) completed follow-up and FeNO monitoring. Of which, 26 children (16.3%) had AE. AE was associated with male children and children with allergic rhinitis (p < 0.05). While, children with AE tended to have higher FeNO than those without AE, no significant difference was found. The maximum value of FeNO ≥35 ppb was associated with AE (p < 0.05). Children with AE had a significantly decreased baseline forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC), %predicted, forced expiratory flow at 25%–75% of FVC (FEF25%–75%). FEV1/FVC < 80% was associated with AE in children regardless of inhalant allergen sensitization (all p < 0.05).ConclusionBaseline spirometry had a predictive value of AE in school children. Sensitive spirometric parameters such as FEV1/FVC and FEF25%–75% can be used as prognostic factors to predict future childhood AE. FeNO value ≥ 35 ppb during monitoring was associated with AE in school children.

BENEFIT OF SMARTPHONE ALERTS TO IMPROVE ADHERENCE TO INHALED ASTHMA CONTROLLERS

Introduction Improved adherence to controller medications is associated with better asthma control and decreased incidence of asthma exacerbations. Achieving appropriate levels of adherence to daily inhaled medications for asthma is challenging. This study assessed the impact of automated smartphone alerts for missed or late controller inhaler use. Methods Patients with asthma (18+ years) were self-enrolled through web recruitment or enrolled through their PCP/ healthcare system (“managed”). Controller inhaler use was tracked with an electronic medication monitor, and automated alerts were sent to the patients’ smartphone as a push notification 15 minutes after a missed or late dose (based on medication schedule entered). Patients also had the ability to disable the alert to their phone. This study received IRB exemption. Results Data from 2,079 patients were analyzed, of which the majority had alerts enabled (86%, n=1802). Aggregate daily adherence of controller inhalers for patients who enabled the alert was higher than those who disabled the alert (38% vs. 34.4% among self-enrolled (p Conclusions Automated reminders among patients agreeing to receive them, may be beneficial for promoting controller inhaler adherence among adults with asthma. Understanding the characteristics of alert enablers, and their response to intervention, will provide further insight into the role of automated reminders to promote adherence.

Seasonal and geographic variations in the incidence of asthma exacerbations in the United States

ABSTRACTBackground: Exacerbations drive the burden of asthma and lead to significant morbidity and consumption of health care resources. Many prior studies of the epidemiology of asthma exacerbations have relied upon data from hospital care. Objective: The objective of this study was to determine US patterns of geographic and seasonal variations of asthma exacerbations being defined as asthma episodes requiring hospital care and/or a prescription for oral steroid. Methods: The study was a retrospective observational cohort study using administrative claims data for insured individuals from the HealthCore Integrated Research Database, including around 43 million members in the United States. Analyses examined 3 age groups, 6–17, 18–64, and ≥65 years and four US regions, Northeast, Southeast, Central, and Western. Results: Monthly rates of asthma exacerbations showed the greatest variation over the year in children, less so in adults and in the elderly. Clinically important differences in rates of asthma exacerbation were observed between regions with the Western Region having the lowest in all three age groups followed by the Northeast, Central, and Southeast regions. Peaks in children occurred in the early fall following troughs in the summer months, and peaks at year-end occurred in adults, particularly in those over 65 years. Conclusions: There is a striking seasonal variation in asthma exacerbations in the United States. Substantial differences between regions of the United States in asthma exacerbation rates cannot readily be explained and invite further investigation.

Step-down treatment from medium-dosage of budesonide/formoterol in controlled asthma

BackgroundThe stepping down of asthma treatment can be considered when asthma symptoms have been well controlled with inhaled corticosteroids (ICSs)/long-acting β2 adrenergic agonists (LABAs). However, few data are available comparing the efficacy between two step-down strategies, to reduce ICS/LABA dose or to withdraw LABA continuing ICS, in well-controlled asthmatics. MethodsThis was a prospective multicentre randomized, two-arm, controlled study. Ninety-one asthmatic patients controlled by budesonide/formoterol combination (BFC) 320/9 μg twice daily were assigned to 2 stepping-down treatments as follows: the BFC group; BUD/FM 160/4.5 μg twice daily, and the ICS group; ICS (budesonide 400 μg twice daily or equivalent dose of ICS) without LABA, and followed for 12 weeks. The primary outcome was the incidence of asthma exacerbations. Asthma control, pulmonary function tests, and fraction of exhaled nitric oxide (FeNO) were evaluated at the beginning and end of the period. ResultsThe incidence of exacerbations was 16.3% in the BFC groups and 12.5% in the ICS group, which were not different between the groups (p = 0.766). No significant differences were found in QOL score and FeNO between 0 week and 12 week in the both group. FEV1 and FEV1 percentage of the predicted value were lower at week 12 than at week 0 in the ICS group, but not in the BFC group. ConclusionsThe two step-down strategies for 12 weeks have equal acceptability in well-controlled asthmatics treated with medium-dose of BFC, however, withdrawal of LABA may have potential risk to deteriorate FEV1. Clinical trial registrationThis study was registered to UMIN-CTR (http://www.umin.ac.jp/ctr/), UMIN000010333.

Non-adherence to inhaled corticosteroids and the risk of asthma exacerbations in children.

BackgroundNon-adherence to inhaled corticosteroids (ICSs) is a major risk factor for poor asthma control in children. However, little is known about the effect of adherence to ICS on the incidence of asthma exacerbations. The objective of this study was to examine the effect of poor adherence to ICS on the risk of exacerbations in children with asthma.MethodsIn this nested case–control study using data from the Dutch PHARMO Record Linkage System, children aged 5–12 years who had an asthma exacerbation needing oral corticosteroids or hospital admission were matched to patients without exacerbations. Refill adherence was calculated as medication possession ratio from ICS-dispensing records. Data were analyzed using a multivariable multiplicative intensity regression model.ResultsA total of 646 children were included, of whom 36 had one or more asthma exacerbations. The medication possession ratio was 67.9% (standard deviation [SD] 30.2%) in children with an exacerbation versus 54.2% (SD 35.6%) in the control group. In children using long-acting beta-agonist, good adherence to ICS was associated with a higher risk of asthma exacerbations: relative risk 4.34 (95% confidence interval: 1.20–15.64).ConclusionIn children with persistent asthma needing long-acting beta-agonist, good adherence to ICS was associated with an increased risk of asthma exacerbations. Possible explanations include better motivation for adherence to ICS in children with more severe asthma, and reduced susceptibility to the consequences of non-adherence to ICS due to overprescription of ICS to children who are in clinical remission. Further study into the background of the complex interaction between asthma and medication adherence is needed.

Incidence and Triggers of Asthma Exacerbations Attended in the Emergency Department as a Level of Care Indicator (ASMAB III, 2005 and ASMAB IV, 2011)

IntroductionThe identification of asthma exacerbations (AE) seen in emergency departments and in the home is proposed as a parameter of asthma control and for monitoring environmental triggers. Patients and methodsAll AEs seen in 2005 and 2011 in the reference hospital of the region and in the patients’ homes by the Emergency Medical Services were identified. ResultsThe incidence of AE was 1.93/106inhabitants/day during 2005, and 2/106inhabitants/day in 2011. The most common triggers were slow onset common cold of more than 24h duration in 104/219 (47%) AEs in 2005 and 107/220 (49%) in 2011; prior bronchial symptoms with cough, expectoration and fever were recorded in 41/219 (19%) in 2005 and in 57/220 (26%) AEs in 2011. In total, 49% (2005) and 74% (2011) of the AEs had onset more than 24h before admission. ConclusionsNo significant differences were observed in the rate of attendance in the emergency department due to AE between 2005 and 2011. The most common triggers were common cold and bronchial symptoms with expectoration and fever. AE had begun more than 24h previously in at least half of cases. These findings appear to suggest that there may be a scope for improvement in the outpatient care of the asthmatic patient.

Herbal Medicine Cordyceps sinensis Improves Health-Related Quality of Life in Moderate-to-Severe Asthma.

Moderate-to-severe asthma has a substantial impact on the health-related quality of life (HR-QOL) of the patients. Cordyceps sinensis is a traditional Chinese medicine that is evaluated clinically for the treatment of many diseases, such as chronic allograft nephropathy, diabetic kidney disease, and lung fibrosis. In order to investigate the effects of Cordyceps sinensis on patients with moderate-to-severe persistent asthma, 120 subjects were randomized to receive Corbin capsule containing Cordyceps sinensis for 3 months (treatment group, n = 60), whereas the control group (n = 60) did not receive treatment with Corbin capsule. Inhaled corticosteroid and as-needed β-agonists were used in the treatment of both groups. HR-QOL was measured with the Juniper's Asthma Quality of Life Questionnaire (AQLQ). The incidence of asthma exacerbation, pulmonary function testing, and serum measurements of inflammatory mediators were also evaluated. The results showed that the treatment group indicated a significant increase in AQLQ scores and lung function compared with the control group. The expression levels of the inflammation markers IgE, ICAM-1, IL-4, and MMP-9 in the serum were decreased and IgG increased in the treatment group compared with the control group. Therefore, the conclusion was reached that a formulation of Cordyceps sinensis improved the HR-QOL, asthma symptoms, lung function, and inflammatory profile of the patients with moderate-to-severe asthma. This trial is registered with ChiCTR-IPC-16008730.

Incidencia y desencadenantes de las agudizaciones asmáticas atendidas en Urgencias como muestra del nivel asistencial (ASMAB III, 2005 y ASMAB IV, 2011)

IntroductionThe identification of asthma exacerbations (AE) seen in emergency departments and in the home is proposed as a parameter of asthma control and for monitoring environmental triggers. Patients and methodsAll AEs seen in 2005 and 2011 in the reference hospital of the region and in the patients’ homes by the Emergency Medical Services were identified. ResultsThe incidence of AE was 1.93/106inhabitants/day during 2005, and 2/106inhabitants/day in 2011. The most common triggers were slow onset common cold of more than 24h duration in 104/219 (47%) AEs in 2005 and 107/220 (49%) in 2011; prior bronchial symptoms with cough, expectoration and fever were recorded in 41/219 (19%) in 2005 and in 57/220 (26%) AEs in 2011. In total, 49% (2005) and 74% (2011) of the AEs had onset more than 24h before admission. ConclusionsNo significant differences were observed in the rate of attendance in the emergency department due to AE between 2005 and 2011. The most common triggers were common cold and bronchial symptoms with expectoration and fever. AE had begun more than 24h previously in at least half of cases. These findings appear to suggest that there may be a scope for improvement in the outpatient care of the asthmatic patient.

Efficacy and safety of an anti–IL-13 mAb in patients with severe asthma: A randomized trial

Approximately 5% to 10% of asthmatic patients achieve incomplete symptom control on current therapies. The association of IL-13 with asthma pathology and reduced corticosteroid sensitivity suggests a potential benefit of anti-IL-13 therapy in refractory asthma. GSK679586, a humanized mAb, inhibits IL-13 binding to both IL-13 receptor α1 and α2. We sought to evaluate the efficacy and safety of GSK679586 in patients with severe asthma refractory to maximally indicated doses of inhaled corticosteroids. Patients who remained symptomatic (Asthma Control Questionnaire score ≥1.5) after uptitration to 1000 μg/d fluticasone propionate or greater were randomized to 3 once-monthly intravenous infusions of 10 mg/kg GSK679586 (n = 99) or placebo (n = 99). Treatment differences in adjusted mean change from baseline over 12 weeks were nonsignificant for Asthma Control Questionnaire symptom scores (the primary end point; GSK679586 = -0.31, placebo = -0.17, P = .058) and FEV₁ (GSK679586 = -0.01, placebo = 0.03, P = .276). Similar analyses in patients with increased serum IgE levels, blood eosinophil counts, or both were also negative. Incidence of asthma exacerbations was similar between treatments. Most adverse events were nonserious and unrelated to treatment. Two GSK679586-treated patients had treatment-related serious adverse events (lethargy and supraventricular extrasystoles). Although well tolerated, GSK679586 did not demonstrate clinically meaningful improvements in asthma control, pulmonary function, or exacerbations in patients with severe asthma. Further studies are needed to determine whether therapies targeting IL-13, the functionally related IL-4 cytokine, or both can provide clinical benefit in patients with severe refractory asthma or a subpopulation of these patients beyond that achievable with high-dose corticosteroids.

As-needed inhaled corticosteroids vs routine inhaled corticosteroids for asthma children：an evidence-based analysis of safety and efficacy

Objective To compare the safety and efficacy of intermittent inhaled corticosteroids(ICS,test group)and routine ICS(control group)treatment strategy for asthma in children.Methods Databases of PubMed,Cochrane Library,clinicaltrials.gov and Chinese Biomedical Literature were searched for relevant studies published from 1980 to 2013.Results Using the predefined key words,we identified 943citations,and finally 4parallel-designed,prospective,randomized controlled studies(5comparison groups)were included in this meta-analysis.We found that there were no significant differences between the two groups in terms of incidence of asthma exacerbations(OR:1.25,95%CI:0.87-1.78,P=0.22),re-hospitalization rate(OR:0.85,95%CI:0.28-2.57,P=0.77),improvement of symptoms and life quality(WMD:0.02,95%CI:-0.19-0.23,P=0.88),or incidence of overall severe adverse events(OR:0.81,95%CI:0.30-2.17,P=0.67).However,improvement of the peak expiratory flow rate(PEFR)in the control group was significantly greater than that in the test group(WMD:2.76,95%CI:0.69-4.82,P=0.009),and the increase of body height in the test group was significantly greater than(by 0.51cm)that in the control group(WMD:-0.51,95%CI:-0.87--0.16,P=0.005).Heterogeneity analysis showed that the studies had good homogeneity.Conclusion The as-needed ICS and routine ICS have similar efficacy in treatment of child asthma.Routine ICS can greatly improve the PEFR,but it may have an adverse impact on the body height of Children.

Incidence and risk factors for exacerbations of asthma during pregnancy

BackgroundAsthma is one of the most common chronic diseases among pregnant women. Acute exacerbations of asthma during pregnancy have an unfavorable impact on pregnancy outcome. This review provides an overview of current knowledge of incidence, mechanisms, and risk factors for acute exacerbations of asthma during pregnancy.MethodsA narrative literature review was carried out using the PubMed database.ResultsDuring pregnancy, up to 6% of women with asthma are hospitalized for an acute exacerbation. The maternal immune system is characterized by a very high T-helper-2:T-helper-1 cytokine ratio during pregnancy and thereby provides an environment essential for fetal survival but one that may aggravate asthma. Cells of the innate immune system such as monocytes and neutrophils are also increased during pregnancy, and this too can exacerbate maternal asthma. Severe or difficult-to-control asthma appears to be the major risk factor for exacerbations during pregnancy, but studies also suggest that nonadherence with controller medication and viral infections are important triggers of exacerbations during pregnancy. So far, inconsistent findings have been reported regarding the effect of fetal sex on exacerbations during pregnancy. Other risk factors for exacerbation during pregnancy include obesity, ethnicity, and reflux, whereas atopy does not appear to be a risk factor.DiscussionThe incidence of asthma exacerbations during pregnancy is disturbingly high. Severe asthma – better described as difficult-to-control asthma – nonadherence with controller therapy, viral infections, obesity, and ethnicity are likely to be important risk factors for exacerbations of asthma during pregnancy, whereas inconsistent findings have been reported with regard to the importance of sex of the fetus.

A Systematic Review of Long-Acting β2-Agonists Versus Higher Doses of Inhaled Corticosteroids in Asthma

To compare the efficacy of inhaled corticosteroids (ICS) plus long-acting β2 agonist (LABA) versus higher doses of ICS in children/adolescents with uncontrolled persistent asthma. Randomized, prospective, controlled trials published January 1996 to January 2012 with a minimum of 4 weeks of LABA+ICS versus higher doses of ICS were retrieved through Medline, Embase, Central, and manufacturer's databases. The primary outcome was asthma exacerbations requiring systemic corticosteroids; secondary outcomes were the pulmonary function test (PEF), withdrawals during the treatment period, days without symptoms, use of rescue medication, and adverse events. Nine studies (n = 1641 patients) met criteria for inclusion (7 compared LABA+ICS versus double ICS doses and 2 LABA+ICS versus higher than double ICS doses). There was no statistically significant difference in the number of patients with asthma exacerbations requiring systemic corticosteroids between children receiving LABA+ICS and those receiving higher doses of ICS (odds ratio = 0.76; 95% confidence interval: 0.48-1.22, P = .25, I(2) = 16%). In the subgroup analysis, patients receiving LABA+ICS showed a decreased risk of asthma exacerbations compared with higher than twice ICS doses (odds ratio = 0.48; 95% confidence interval: 0.28-0.82, P = .007, I(2)= 0). Children treated with LABA+ICS had significantly higher PEF, less use of rescue medication, and higher short-term growth than those on higher ICS doses. There were no other significant differences in adverse events. There were no statistically significant group differences between ICS+LABA and double doses of ICS in reducing the incidence of asthma exacerbations but it did decrease the risk comparing to higher than double doses of ICS.

Effect of Omalizumab as Add-On Therapy on Asthma-Related Quality of Life in Severe Allergic Asthma: A Brazilian Study (QUALITX)

Objective. To assess the impact of omalizumab as an add-on therapy to standard treatment with inhaled corticosteroids (ICS) and long-acting beta-2 agonists (LABA) on asthma-related quality of life (QoL) in patients with severe allergic asthma. Methods. This was a 20-week, randomized, open-label, study involving Brazilian patients (>12 years) with severe persistent allergic asthma inadequately controlled despite regular treatment with, at least, ICS (≥500 μg/day fluticasone or equivalent) + LABA. The primary objective was to assess the mean change from baseline in overall Asthma-related Quality of Life Questionnaire (AQLQ) score in omalizumab-treated patients compared with the control group. Secondary outcome measures included rescue medication use, incidence of asthma exacerbations, perception of treatment efficacy among patients, mean change from baseline in AQLQ score, and >1.5-point increase in overall AQLQ score. Results. In the omalizumab group, overall AQLQ score was 3.2 (0.9) (mean [SD]) at baseline and 4.4 (1.3) at week 20 versus 3.0 (1.0) at baseline and 3.0 (1.1) at week 20 in the control group. Mean change from baseline on overall AQLQ score at week 20 in the omalizumab group was 1.2 (0.2) versus 0 (0.1) in the control group, showing a significant increase in scores from baseline in the omalizumab group (p < .001). There was also a statistically significant difference (p < .001) in the number of patients who showed a >1.5-point increase from baseline in overall AQLQ score after 20 weeks, thus indicating a better QoL in the omalizumab group. There was no significant difference with respect to the use of rescue medication, incidence of asthma exacerbation, and adverse events between treatment groups. The global evaluation of treatment effectiveness was significantly better for omalizumab (p < .001). Conclusion. Omalizumab was well tolerated and significantly improved the overall AQLQ score. Hence, it is a potential add-on therapy for severe persistent allergic asthma not controlled by standard prescribed treatment in Brazilian patients.

Incidence and Characteristics of Asthma Exacerbations in Barcelona (ASMAB II)

Introduction A study has been carried out on the incidence and clinical characteristics of asthma exacerbations (AE) seen in hospital accident and emergency departments (HA&ED) and domiciliary services (DS) in Barcelona. Patients and methods AEs were identified over a 56-day-period during the October and November 2003 and the patients seen in university hospitals were interviewed. Results A total of 262 AE were identified, 188 in hospital accident and emergency departments and 82 in domiciliary care, which was a mean of 4.6 AE/day, giving an incidence of 0.37 AE/10 5 inhabitants. This incidence was no different from that obtained in the same months in 2002 ( P > 0.05). The mean age (±standard deviation) of the143 cases of AE seen in university hospitals was 41±17 years; 87/143 (60%) were women and 57/138 (41%) smokers. In 36/61 (59%) the AE started in the home; in 88/132 (61%) it began 24 hours before arriving at the hospital centre. In 78/123 cases (63%) slow onset of nasal cold was noted before the AE and a viral infection was suspected. Inhaled corticosteroids were administered to 45/112 patients (40%), and only one was also given oral corticosteroids 12 hours before admission. The AEs were mild in 38/75 cases (51%), moderate in 28/75 (37%), severe in 8/75 (11%) and almost fatal in one patient (1.3%). Around 10% (13/137) of patients (10%) were readmitted. Conclusions The daily incidence of AE is 0.37/10 5 inhabitants. More than half of the exacerbations started after nasal cold and 11% of the AEs were severe.

Incidencia y características de las agudizaciones asmáticas en Barcelona (ASMAB II)

Introduction A study has been made on the incidence and clinical characteristics of asthma exacerbations (AE) seen in hospital emergency departments (HED) and domiciliary services (DS) in Barcelona. Patients and methods AEs were identified over a 56 day period during the months of October and November 2003 and the patients seen in university hospitals were interviewed. Results A total of 262 AE were identified, 188 in hospital emergency departments and 82 in domiciliary, which was a mean of 4.6 AE/day, giving an incidence of 0.37 AA/10 5 inhabitants. This incidence was no different from that obtained in the same months in 2002 ( P>0.05). The mean age (±standard deviation) of the143 cases of AE seen in university hospitals was 41±17 years; 87/143 (60%) were women and 57/138 (41%), smokers. In 36/61 (59%) the AE started in the home; in 88/132 (61%) it began 24 hours before arriving at the hospital centre. In 78/123 cases (63%) slow onset of nasal catarrh was noted before the AE and a viral infection was suspected. Inhaled corticoids were given to 45/112 patients (40%), and only one added oral corticoids 12 hours before admission. The AE were mild in 38/75 cases (51%), moderate in 28/75 (37%), severe in 8/75 (11%) and almost fatal in one patient (1.3%). Around 10% (13/137) of patients (10%) were re-admitted. Conclusions The daily incidence of AE is 0.37/10 5 inhabitants. More than half of the exacerbations started after nasal catarrh and 11% of the AE were severe.