Genetics and COVID-19: How to Protect the Susceptible.

Along with the potential for breakthroughs in care and prevention, the search for genetic mechanisms underlying the spread and severity of coronavirus disease 2019 (COVID-19) introduces the risk of discrimination against those found to have markers for susceptibility. We propose new legal protections to mitigate gaps in protections under existing laws.

National expert consensus on short-acting beta2-agonist overreliance in asthma care in Malaysia.

OBJECTIVE: Inappropriate use of short-acting beta2-agonists (SABA) in asthma has been associated with undesired outcomes. This national expert consensus was developed to increase awareness of SABA overuse and provide recommendations on the ways to eliminate SABA overprescription and overreliance in Malaysia. DATA SOURCES: This expert consensus was developed by searching the PubMed database, using index terms to identify SABA overuse-related burden and recommendations made in asthma guidelines. Consensus recommendations were made via the Delphi method, involving a Malaysian expert committee comprising 13 healthcare professionals (five pulmonologists, four family medicine specialists, two emergency medicine physicians and two pharmacists). STUDY SELECTIONS: The articles reviewed include randomized controlled trials, systematic reviews, meta-analyses, observational studies, guidelines, and surveys, with abstracts in English and published up until June 2023. Relevant recommendations were also sourced from verified websites of medical organizations and societies. RESULTS: Eleven consensus statements were developed, each statement achieving a priori agreement level of at least 70%. The statements reflect SABA overreliance in asthma care, as well as recommendations to eliminate SABA overprescription and overreliance in Malaysia. Supporting evidence in the literature as well as expert committee discussions leading to the development of the finalized statements were elaborated. CONCLUSION: This national expert consensus discussed the burden of SABA overreliance and made specific recommendations to eliminate SABA overprescription and overreliance in the Malaysian context. This consensus document is anticipated to impart better awareness among Malaysian healthcare providers and contribute to the continuous improvement of asthma care in the country.

The Genetic Information Nondiscrimination Act and workplace genetic testing: Knowledge and perceptions of employed adults in the United States.

Workplace wellness programs are an emerging avenue for health-related genetic testing, with some large employers now offering such testing to employees. Employees' knowledge and concerns regarding genetic discrimination may impact their decision-making about and uptake of workplace genetic testing (wGT). This study describes employed adults' objective knowledge of the Genetic Information Nondiscrimination Act (GINA) and evaluates how this knowledge correlates with attitudes and beliefs regarding wGT. Analyses utilized data from a large, national web-based survey of employed adults (N = 2000; mean age = 43 years; 51% female; 55.2% college educated). Overall, most respondents (57.3%) said they were unaware of any laws protecting against genetic discrimination. Specifically, 62.6% indicated they were not at all familiar with GINA. The primary study outcome was respondents' score on a 13-item measure assessing knowledge of basic facts about GINA. Participants had low overall GINA knowledge (M = 4.6/13 items correct (35%), SD = 2.9), with employees often presuming GINA offers greater legal protections than it does (e.g., 45.3% erroneously endorsed that GINA protected against discrimination in life insurance). Logistic regression analyses assessed associations between GINA knowledge and employees' demographic characteristics, prior experience with genetic testing, and attitudes regarding wGT. Variables significantly associated with GINA knowledge included higher interest in wGT (aOR = 1.45; 95% CI: 1.20, 1.77), self-reported familiarity with GINA (aOR = 2.02; 95% CI: 1.64, 2.50), and favorable attitudes toward wGT (aOR = 1.92; 95% CI: 1.52, 2.44). Results indicate public knowledge of GINA remains low over 15 years after its passage. These findings highlight the need for employee education on GINA before participating in wGT, as well as broader public education on GINA's legal protections and limitations. Genetic counselors lead GINA education efforts in clinical and public settings and can play a pivotal role in ongoing public education initiatives about GINA.

Looking Beyond GINA: Policy Approaches to Address Genetic Discrimination.

Concerns about genetic discrimination (GD) often surface when discussing research and innovation in genetics. Over recent decades, countries around the world have attempted to address GD using various policy measures. In this article, we survey these approaches and provide a critical commentary on their advantages and disadvantages. Our examination begins with regions featuring extensive policy-making activities (North America and Europe), followed by regions with moderate policy-making activities (Australia, Asia, and South America) and regions with minimal policy-making activities (the Middle East and Africa). Our analysis then turns to emerging issues regarding genetic testing and GD, including the expansion of multiomics sciences and direct-to-consumer genetic tests outside the health context. We additionally survey the shortcomings of current normative approaches addressing GD. Finally, we conclude by highlighting the evolving nature of GD and the need for more innovative policy-making in this area.

Short-acting ß2-agonists over-prescription in patients with asthma: an Indian subset analysis of international SABINA III study.

OBJECTIVE: The SABINA (SABA use IN Asthma) program was initiated to describe short-acting ß2-agonists (SABA) prescription patterns and assess the impact of its over-prescription on exacerbation risk and asthma control. We evaluated SABA prescription patterns in patients with asthma in the Indian cohort of SABINA III. METHODS: This multi-centre, observational, cross-sectional study included retrospective and real-time electronic data collection. Data were extracted from medical records of patients with asthma (aged >12 years) having >3 consultations with the same healthcare practitioners between March 2019 and January 2020. The data included prescriptions of SABA and other asthma treatments and over-the-counter (OTC) purchases of SABA. SABA prescriptions were categorized by the number of SABA canisters prescribed in the 12 months preceding the study visit. RESULTS: A total of 510 patients with asthma were included from specialist care (mean age 49.1 years; 57.65 females), with 8.2% classified with mild asthma and 91.8% with moderate-to-severe asthma. SABA as monotherapy and add-on to maintenance therapy was prescribed to 4.5% (n = 23) and 44.9% (n = 229) of patients, respectively. While ICS monotherapy and ICS/LABA were prescribed to 5.1% (n = 26) and 93.3% (n = 476) of patients, respectively. SABA was found to be over-prescribed (≥3 SABA canisters/year) among 23.9% of patients (n = 122). Additionally, 8% of patients (n = 41) purchased SABA OTC without prescription. CONCLUSIONS: Nearly one-fourth of patients with asthma in India were over-prescribed SABA. Educational programmes targeted at national and regional levels should be expanded to raise greater asthma awareness and encourage the adoption of guideline-directed asthma treatment plans among healthcare practitioners.

Asthma control in Kazakhstan: need for urgent action.

BACKGROUND: Asthma control, patients' awareness level and adherence to treatment in Kazakhstan have never been studied. The aim of this study was to verify the prevalence of controlled, poorly controlled and uncontrolled asthma in a large sample of three largest cities of Kazakhstan. METHODS: We recruited 600 (median age 54 (interquartile range (IQR) 22) years, 64% females) patients with diagnosis confirmed earlier in the outpatient facilities in Almaty, Astana and Shymkent in 2020-2021. We offered a structured questionnaire on asthma control and risk factors as of GINA and performed spirometry. We report the prevalence of asthma control, knowledge and skills and pharmacological treatment with 95% confidence interval (CI) and the association of selected predictors with asthma control. RESULTS: With the median of 9 (IQR 13) years of diagnosis, 40% of patients had comorbid COPD and 42% had allergic rhinitis, whereas 32% lived with pets. Asthma was well-controlled in only 12.3% (95% CI 9.7-15.0), partly controlled in 29.8% (95% CI 26.2-33.5) and uncontrolled in 57.8% (95% CI 53.9-61.8) patients. ACQ-5 score (range 0-5.8, median 2) equaled 0.2 (IQR 0.85) in well-controlled asthma patients, 1.4 (IQR 1) in partly controlled and 2.8 (IQR 1.4) in uncontrolled asthma patients. Knowledge and skills levels were very low. Only 54% were on inhaled corticosteroids (52.2% of them used budesonide/formoterol and 39.5% used fluticasone/salmeterol). 39% used steroids per os or parenterally within a period of 12 months (51% of patients with uncontrolled asthma). CONCLUSION: Asthma control, knowledge and skills levels of asthma patients in the largest cities of Kazakhstan remain unacceptably low, whereas pharmacological treatment is far from optimal. Urgent action should be taken to support doctors' training, and we call to launch a national asthma program to coordinate asthma care in Kazakhstan.

Controversies in the treatment of mild asthma. What novelties and practical implications?

Mild asthma is prevalent in childhood and causes as many as 30%-40% asthma exacerbations requiring emergency visits. The management of "intermittent" and "mild persistent" asthma phenotypes is still a matter of debate, even if the role of inhaled corticosteroids, both continuous and intermittent, is a cornerstone in this field. Recent updates of the guidelines on the strategies to manage these patients are coming, since the role of inflammation in these asthma phenotypes is crucial, as well as the potential side effect and risks of short-acting beta 2 agonists overuse, prescribed as the only "as-needed" treatments. In this paper, we overview the new (r)evolution regarding intermittent and mild persistent asthma management.

Expert Opinion on Practice Patterns in Mild Asthma After the GINA 2019 Updates: A Major Shift in Treatment Paradigms from a Long-Standing SABA-Only Approach to a Risk Reduction-Based Strategy with the Use of Symptom-Driven (As-Needed) Low-Dose ICS/LABA.

PURPOSE OF REVIEW: This expert opinion, prepared by a panel of chest disease specialists, aims to review the current knowledge on practice patterns in real-life management of mild asthma and to address the relevant updates in asthma treatment by The Global Initiative for Asthma (GINA) to guide clinicians for the best clinical practice in applying these new treatment paradigms. RECENT FINDINGS: On the basis of the emerging body of evidence suggesting the non-safety of short-acting ß2-agonists (SABA)-only therapy and comparable efficacy of the as-needed inhaled corticosteroids (ICS)-formoterol combinations with maintenance ICS regimens, GINA recently released their updated Global Strategy for Asthma Management and Prevention Guide (2019). The new GINA 2019 recommendations no longer support the SABA-only therapy in mild asthma but instead includes new off-label recommendations such as symptom-driven (as-needed) low-dose ICS-formoterol and "low dose ICS taken whenever SABA is taken." The GINA 2019 asthma treatment recommendations include a major shift from long-standing approach of clinical practice regarding the use of symptom-driven SABA treatment alone in the management of mild asthma. This expert opinion supports the transition from a long-standing SABA-only approach to a risk reduction-based strategy, with the use of symptom-driven (as-needed) low-dose ICS/LABA in mild asthma patients, particularly in those with poor adherence to controller medications. The thoughtful and comprehensive approach of clinicians to these strategies is important, given that the exact far-reaching impact of this major change in management of mild asthma in the real-world settings will only be clarified over time.

Short-acting bronchodilators purchase as a marker for asthma control.

Background: Administrative data has been used to quantify the amount of medication use in order to identify at-risk asthma patients. In our previous study we used short-acting beta-agonists (SABA) inhalers as a marker for asthma control.Methods: We further analyzed patient data from the SABA inhalers study in which asthma control was classified by GINA guidelines, physician assessment and the patients overall estimation. We identified all short-acting bronchodilator purchases (SABA and anticholinergic inhalers and solutions) in the year prior to administering the questionnaire relating to asthma control, and compared inhaled and systemic steroid use.Results: Of 241 asthma patients, 83 completed questionnaires. Using the GINA guidelines criteria, 26 were symptom controlled, 46 were partially controlled and 11 were uncontrolled. Using patients' overall impression of their asthma control, mean annual short-acting bronchodilator purchases were significantly higher in the partially controlled and uncontrolled patients (10 and 8.9 respectively) than in the controlled patients (2, p = 0.005). Most asthma patients purchase less than half of the controller medications prescribed to them.Conclusion: When using administrative data, 3 or more -of all types of short-acting bronchodilator purchases in one year should alert the physician to evaluate asthma control and purchase alerts should notify both physicians and patients when controller consumption is low.

The prevalence and clinical features of chronic obstructive pulmonary disease patients with traits of asthma in Taiwan.

BACKGROUND/PURPOSE: The application of the checkbox for identifying patients with traits of both chronic obstructive pulmonary disease (COPD) and asthma proposed by the 2015 Global Initiative for Asthma (GINA)/Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations has not been well studied although such identification is important in clinical practice. Thus, we aimed to investigate the prevalence and features of COPD coexistent with asthma traits diagnosed based on the 2015 GINA/GOLD strategies, and explore the gap between guidelines and routine practice in the diagnosis and pharmacological management of such condition in a COPD cohort. METHODS: COPD subjects were enrolled retrospectively throughout Taiwan. A patient record form was completed for each participant and the data were analyzed. RESULTS: Of 340 participants, the prevalence of COPD coexistent with traits of asthma was 39.4% and 30.3% based on guidelines and physician's judgment, respectively. Coexistent patients were characterized by blood eosinophilia, higher total immunoglobulin E (IgE) levels, preserved lung function, and the presence of gastro-esophageal reflux disease and atopic disease while total IgE level > 100 kU/L and the presence of atopic disease were predictors for coexistent patients. Gaps existed in the diagnosis (a weak agreement with kappa = 0.53) and treatment (non-adherence to the preferred therapy in 18.4% of physician-judged coexistent patients) in COPD patients with asthma traits. The exacerbation history was similar between coexistent and non-coexistent patients. CONCLUSION: We found that measuring circulatory eosinophil and total IgE levels may raise clinicians' awareness of the presence of traits of asthma in the management of COPD.

Prevalence of overuse of short-acting beta-2 agonists (SABA) and associated factors among patients with asthma in Germany.

BACKGROUND: Overuse of short-acting beta-2 agonists (SABA), which do not treat the underlying inflammation of asthma, is linked to poor clinical outcomes such as increased exacerbation risk. This study, as part of the SABINA program, estimated the prevalence of SABA overuse and associated variables in outpatients in Germany. METHODS: This retrospective study used anonymized electronic healthcare data from the Disease Analyzer database (IQVIA). A total of 15,640 patients aged ≥ 12 years with asthma who received ≥ 1 SABA prescription(s) between July 2017 and June 2018 in 924 general physician and 22 pneumologist (PN) practices were included. SABA overuse was defined as ≥ 3 prescribed inhalers (~ 200 puffs each) during the study period. The associations between SABA overuse and physician specialty, Global Initiative for Asthma (GINA) steps (based on asthma medications), age, sex, and inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) use were estimated using multivariable regression for patients with probable moderate (GINA step 2) and probable severe (GINA steps 3-5) asthma. RESULTS: Annually, 36% of all patients (GINA steps 1-5) in general and 38% in PN practices received ≥ 3 SABA inhalers. The risk of SABA overuse was 14% higher in patients treated by a general practitioner vs. a PN; 34% and 85% higher in GINA steps 4 and 5, respectively, vs. GINA step 3; and 40% higher in male vs. female patients. CONCLUSIONS: SABA overuse is prevalent among patients with asthma across all GINA steps in Germany, which may indicate suboptimal asthma control. Further studies are needed to investigate the reasons behind SABA overuse.

Efficacy of once-daily tiotropium Respimat in adults with asthma at GINA Steps 2-5.

Tiotropium Respimat is an efficacious add-on to maintenance treatment in patients with symptomatic asthma. Currently, the Global Initiative for Asthma (GINA) strategy recommends tiotropium for patients at Steps 4-5. To assess the clinical benefits of tiotropium Respimat across asthma severities, GINA Steps 2-5, a post hoc analysis of five double-blind trials (12-48-weeks; patients aged 18-75 years) investigated the effect of tiotropium Respimat, 5 µg or 2.5 µg, versus placebo, on peak forced expiratory volume in 1 s (FEV1) within 3 h post-dose (FEV1(0-3h)) response, and Asthma Control Questionnaire-7 (ACQ-7) responder rate. GINA step grouping was based on patients' background treatment regimen. Baseline characteristics of patients (N = 2926) were balanced between treatments. Tiotropium Respimat showed consistent improvements in lung function across GINA steps; placebo-corrected peak FEV1(0-3h) improvements after tiotropium Respimat 5 µg and 2.5 µg were: Step 2 (Week 8), 135 mL (95% confidence interval: 84, 187) and 155 mL (103, 206); Step 3 (Week 24), 187 mL (139, 235) and 235 mL (187, 283); Step 4 (Week 24), 111 mL (63, 159) and 181 mL (35, 326); Step 5 (Week 24; 5 µg only), 164 mL (5, 323). Asthma control improved with tiotropium Respimat versus placebo, showing statistical significance (nominal P value) with tiotropium Respimat 5 µg at Step 4 (odds ratio 1.36 [1.03, 1.78]). Safety profiles were similar between treatments. In conclusion, tiotropium Respimat add-on therapy improves lung function, and may improve asthma control, in adults across disease severities.

It is time to change the way we manage mild asthma: an update in GINA 2019.

Asthma is a heterogeneous lung disease, usually characterised by chronic airway inflammation. Although evidence-based treatments are available in most countries, asthma control remains suboptimal, and asthma-related deaths continue to be an ongoing concern. Generally, it is believed that between 50 to 75% of patients with asthma can be considered as having mild asthma.Previous versions of Global Initiative for Asthma (GINA) suggested that mild asthma in adults can be well managed with either reliever medications, for example, short-acting beta2 agonists (SABA) alone or with the additional use of controllers such as regular low-dose inhaled corticosteroids (ICS). Given the low frequency or non-bothersome nature of symptoms in mild asthma, patients' adherence towards their controller medications, especially to ICS is usually not satisfactory. Such patients often rely on SABA alone to relieve symptoms, which may contribute to SABA over-reliance. Overuse of relievers such as SABAs has been associated with poor asthma outcomes, such as exacerbations and even deaths. The new GINA 2019 asthma treatment recommendations represent significant shifts in asthma management at Steps 1 and 2 of the 5 treatment steps. The report acknowledges an emerging body of evidence suggesting the non-safety of SABAs overuse in the absence of concomitant controller medications, therefore does not support SABA-only therapy in mild asthma and has included new off-label recommendations such as symptom-driven (as-needed) low dose ICS-formoterol and "low dose ICS taken whenever SABA is taken".The GINA 2019 report highlights significant updates in mild asthma management and these recommendations represent a clear deviation from decades of clinical practice mandating the use of symptom-driven SABA treatment alone in those with mild asthma. While the new inclusions of strategies such as symptom-driven (as-needed) ICS-formoterol and "ICS taken whenever SABA is taken" are based on several key trials, data in this context are still only emergent data, with clear superiority of as needed ICS-formoterol combinations over maintenance ICS regimens yet to be established for valid endpoints. Nevertheless, current and emerging data position the clinical asthma realm at a watershed moment with imminent changes for the way we manage mild asthma likely in going forward.

Asthma control and quality of life in a real-life setting: a cross-sectional study of adult asthma patients in Japan (ACQUIRE-2).

Objective: The level of asthma control in adult asthma patients receiving treatment in clinical practice from allergy and/or respiratory specialists in Japan remains unclear. We conducted the ACQUIRE-2 study (NCT02640742) to evaluate level of asthma control, asthma symptoms, health-related quality of life (HR-QoL), and reliever medication use in this setting. Methods: This observational study was undertaken between December 2015 and June 2016 in 58 medical institutions across Japan. We enrolled outpatients aged ≥20 years diagnosed with asthma for ≥1 year who were being managed by specialists. Criteria to evaluate the level of asthma control were based on modified definitions of the Asthma Prevention and Management Guideline 2015, Japan (JGL 2015) and Global Initiative for Asthma (GINA) 2012. Asthma symptoms, HR-QoL, and reliever medication use were also evaluated. Results: Of 1250 enrolled patients, 1175 were analyzed, 62.9% of whom were women. Mean (± standard deviation) age and duration of asthma were 59.7 ± 14.5 years and 16.9 ± 14.0 years, respectively. Using JGL 2015-based criteria, 24.4%, 69.2%, and 6.5% of patients had well-controlled, insufficiently-controlled, and poorly-controlled asthma, respectively. Using GINA-based criteria, 35.1%, 49.8%, and 15.1% of patients had controlled, partly controlled, and uncontrolled asthma, respectively. Daytime and nighttime asthma symptoms were experienced by 51.5% and 44.9% of patients, respectively. The mean MiniAQLQ score was 5.8 ± 1.0 (7-point scale). Conclusions: Asthma was not well-controlled in the majority of patients in this study. To achieve better asthma control, improvements in symptom monitoring and management may be required.

Perception of asthma control among asthmatics seen inChest Clinic at Tertiary Hospital, Addis Ababa, Ethiopia.

BACKGROUND: Patient awareness of asthma severity is important for optimal asthma management. However, there is often a discrepancy between physician assessment of asthma control based on guidelines and patient discernment of control. We compared physician and patient perception of asthma control in a clinic population seen at a tertiary hospital in Addis Ababa, Ethiopia. METHODS: In this cross-sectional study, 182 consecutive patients with a physician diagnosis of asthma seen in Chest Clinic at Tikur Anbessa Specialized Hospital (TASH) between July and December 2015 were studied. Demographics, asthma symptoms, medication use in the past month, and self-perception of asthma control in the past 7 days were obtained from the clinic records. Physician assessed asthma control was based on the GINA asthma symptom control assessment tool. Lung function was measured using a Diagnostic EasyOne Plus model 2001 SN spirometer. The institutional review board approved the study protocol. RESULTS: Of the 182 subjects, 68.1% were female. The mean age was 52 ± 12 years, and the mean (SD) duration of asthma was 19.4 ± 12.7 years. Forty-four (24.2%) patients had physician determined well-controlled asthma and 138 (75.8%) patients had physician determined partly controlled/uncontrolled asthma. One hundred and fifty-one (83%) patients thought their asthma control was good. However, the degree of concordance between physician evaluation and patient perception of asthma control was low (kappa index = 0.09). On multivariate analysis, self-perceived poor asthma control was associated with any activity limitation due to asthma and inconsistent inhaled corticosteroid use. CONCLUSION: In our study, the first of its kind in Ethiopia, a high percent of patients with physician determined well-controlled asthma has appropriate perception of their disease state. However, those patients with partly controlled/uncontrolled asthma had poor self-perception of their disease, emphasizing the need for further patient education. These conclusions may be especially useful in the care of asthmatics from other low-income countries.

[The quality of life and accessibility of medical care in persons with bronchial asthma in the Republic of Kazakhstan].

The access barriers to asthma basic treatment and medical care in many countries are an urgent problem and emphasize the need for population studies to examine the associated risk factors for barriers to health care, causes of severe exacerbations, disruption of life quality, and the development of preventive measures. The purpose of study was to evaluate the association of quality of life, access to medical care and emergency of severe exacerbation in persons with bronchial asthma in the Republic of Kazakhstan. The cross-sectional study was applied. The sample included 3,572 patients of both genders aged 18-59 years with bronchial asthma, registered in out-patient clinics of the Republic of Kazakhstan. The assessment of frequency of severe exacerbation in patients with asthma, depending on availability of medical care, demonstrated significant differences in groups of minimal, average and maximum decrease (χ2 = 160.66, 2057.06, 166.19, p<0.001). The most of patients in group with severe asthma exacerbations more than 3 times per year had signs of a maximum decrease in access to medical care - 53.5% and 42.11% were classified as a medium-level barrier of access. The indicator of quality of life was significantly lower in group of patients with severe exacerbation of disease more than 3 times per year in groups with severe access barriers as compared to group with similar number of exacerbations where the number of barriers was less than two - 10.85 vs. 15, 28 (t = 3.985, D.f. = 1, p = 0.003). The study permitted to conclude that improving quality and increasing availability of medical care of asthmatic patient is the key to managing course of asthma at stage of diagnosis and during treatment as well.

Evaluation of a diagnostic therapeutic educational pathway for asthma management in youth.

BACKGROUND: In spite of some evidence for positive effects of patient's education to asthma self-management by randomized clinical trials, there are few studies on the impact of patient' s educational programs in the real world. We aimed to assess the impact of a diagnostic therapeutic educational pathway (DTEP) on asthma control of children and adolescents by comparing frequency of outcomes indicative of asthma control before and after attending the pathway. METHODS: This is a retrospective cohort study including all patients aged 6-11 and 12-17 years who attended the DTEP in 2007-2014. The DTEP includes 3 specialist's evaluations at 8- to 12-week intervals and two follow-up visits. Patients and their parents receive an educational course concerning prevention measures, early recognition of symptoms, and appropriate use of drugs and devices. The rates of hospitalizations, outpatient services, emergency room visits, and drug prescriptions were considered as outcomes and computed as number of events divided by person-time. RESULTS: A total of 806 patients were enrolled. A statistically significant decrease in rates from before to after DTEP was observed for almost all outcomes, in both age groups, with relative risks ranging from 0.12 to 0.60. The rates of drug prescription showed a statistically significant decrease, from before to after DTEP, for each type of medicine for asthma, in both age groups, from percent difference of -66% to -24.3%. CONCLUSIONS: The positive impact of this program on the outcomes indicative of asthma control in both children and adolescents suggests that it may be valuable for asthma management.

Determination of asthma control using administrative data regarding short-acting beta-agonist inhaler purchase.

BACKGROUND: Symptom control is a primary goal in asthma. We hypothesized that administrative data regarding rescue inhaler purchases may correlate with asthma symptom control. METHODS: We identified all patients who purchased short-acting beta-agonist (SABA) inhalers during the course of one year in the database of a Health Maintenance Organization (HMO). Primary physicians identified asthma patients and classified their asthma symptom control into three groups according to the Global Initiative for Asthma (GINA) guidelines. Asthma patients were asked to answer symptom questionnaires and grade their asthma control. SABA inhaler purchases were compared between asthma control groups as classified by the guidelines, the physicians and the patients. We also compared the agreement on asthma control between the three methods of classification. RESULTS: Of 241 asthma patients, 83 completed the questionnaires. Using the GINA guidelines criteria, 26 were symptom controlled, 46 were partially controlled and 11 were uncontrolled. SABA inhaler purchases were not significantly lower in the controlled group. Using patients' overall impression of their asthma control, the mean numbers of SABA inhalers purchased were 1.5, 4.4 and 6.4 per year in the controlled, partially controlled and uncontrolled groups, respectively (p = 0.03). Patients' classification of asthma control had better agreement (kappa = 0.34) with GINA guidelines than physician's' agreement (kappa = 0.05). CONCLUSION: When using administrative data for asthma patients, 2 or more SABA inhaler purchases in one year should alert the physician for the need for asthma control evaluation. Purchase of at least 4 SABA inhalers a year may be regarded as a marker for asthma that is not controlled.

Indirect comparison of bronchial thermoplasty versus omalizumab for uncontrolled severe asthma.

OBJECTIVE: Bronchial thermoplasty (BT) as an add-on therapy for uncontrolled severe asthma is an alternative to biologic therapies like omalizumab (OM). We conducted an indirect treatment comparison (ITC) to appraise comparative effectiveness of BT and OM. METHODS: A systematic literature review identified relevant randomized controlled trials. The ITC followed accepted methodology. RESULTS: The ITC comprised a sham-controlled trial of BT (AIR2) and two placebo-controlled trials of OM (INNOVATE; EXTRA). Comparing the BT post-treatment period to ongoing treatment with OM, showed no significant differences in the rate ratios (RRs) for severe exacerbations (RR of BT versus OM = 0.91 [95% CI: 0.64, 1.30]; p = 0.62) or hospitalizations (RR = 0.57 [95% CI: 0.17, 1.86]; p = 0.53); emergency department visits were significantly reduced by 75% with BT (RR = 0.25 [95% CI: 0.07, 0.91]; p = 0.04); the proportions of patients with clinically meaningful response on the asthma quality-of-life questionnaire were comparable (RR = 1.06 [95% CI: 0.86, 1.34]; p = 0.59). The RR for exacerbations statistically favours OM over the total study period in AIR2 (RR = 1.50 [95% CI: 1.11, 2.02]; p = 0.009) likely reflecting a transient increase in events during the BT peri-treatment period. CONCLUSIONS: The ITC should be interpreted cautiously considering the differences between patient populations in the included trials. However, based on the analysis, BT compares well with a potentially more costly pharmacotherapy for asthma. Clinicians evaluating the relative merits of using these treatments should consider the totality of evidence and patient preferences to make an informed decision.

Medicinal benefits of Nigella sativa in bronchial asthma: A literature review.

Nigella sativa L. (NS) seeds, known as black seed, is a spice and a traditional herbal medicine used in various diseases including bronchial asthma. This review aimed to assess the studies supporting the medicinal use of NS in asthma and to highlight future research priorities. Various medical databases were searched for the effects of NS and its active secondary metabolites in asthma inflammation and outcomes. There were fourteen preclinical studies describing multiple effects of NS in animal or cellular models of asthma including bronchodilation, anti-histaminic, anti-inflammatory, anti-leukotrienes and immunomodulatory effects. Furthermore, seven clinical studies showed improvements in different asthma outcomes including symptoms, pulmonary function and laboratory parameters. However, often these studies are small and used ill-defined preparations. In conclusion, NS could be therapeutically beneficial in alleviating airway inflammation and the control of asthma symptoms, but the evidence remains scanty and is often based on poorly characterised preparations. Accordingly, well-designed large clinical studies using chemically well characterised NS preparation are required.