Dupilumab efficacy and safety in Latin American patients with uncontrolled, moderate-to-severe asthma: phase 3 LIBERTY ASTHMA QUEST study.

OBJECTIVE: While advances in asthma care have been made in Latin America, there is still a large unmet need in patients with uncontrolled asthma. This post hoc analysis of the QUEST study assessed safety and efficacy of dupilumab in the subgroup of patients enrolled in Latin American countries with a type 2 inflammatory asthma phenotype (blood eosinophils ≥ 150cells/µL or FeNO ≥25ppb). METHODS: LIBERTY ASTHMA QUEST (NCT02414854) was a phase 3, multinational, randomized, double-blind, placebo-controlled study in patients with uncontrolled, moderate-to-severe asthma. Eligible patients ≥ 12 years of age were randomized in a 2:2:1:1 ratio to receive 52 weeks of add-on subcutaneous dupilumab 200 or 300 mg every 2 weeks or matched-volume placebos. Pre-specified co-primary efficacy endpoints were the annualized rate of severe exacerbations during the treatment period and the change from baseline in pre-bronchodilator FEV1 at treatment week 12. Asthma control, changes in asthma biomarker levels, and dupilumab safety were also evaluated. RESULTS: 530 (27.9% of the overall QUEST population; dupilumab: 353, placebo: 177) Latin-American patients were recruited; 420 (79.2%) had a type 2 inflammatory asthma phenotype. Dupilumab vs placebo reduced the annualized rate of severe exacerbations by 52.7% (P < 0.001) and increased pre-bronchodilator FEV1 at week 12 by 0.15 L (P < 0.001), in the type 2 population. Safety was consistent with the known dupilumab safety profile. CONCLUSIONS: Consistent with the results in the overall population, dupilumab reduced the risk of severe asthma exacerbations and improved lung function in Latin American patients with uncontrolled, moderate-to-severe asthma and a type 2 phenotype.

Recomendaciones en el manejo y tratamiento del asma en la Argentina (REMA). Consenso Delphi modificado RAND/UCLA de la Asociación Argentina de Alergia e Inmunología Clínica y Asociación Argentina de Medicina Respiratoria / Recommendations for the Management and Treatment of Asthma in Argentina (RE.M.A). A RAND/UCLA modified Delphi Consensus Argentinian Association of Allergy and Clinical Immunology and Argentinian Association of Respiratory Medicine

El asma es una enfermedad crónica de la vía aérea prevalente en nuestro país, con frecuente mal control. Algunos especialistas de la Asociación de Alergia e Inmunología Clínica y la Asociación Argentina de Medicina Respiratoria han realizado recomendaciones sobre el manejo y tratamiento del asma mediante la metodología de consenso RAND/UCLA Delphi modificada sobre la base de la evidencia científica (GRADE). Este documento provee recomendaciones basadas en la opinión de especialistas y fundamentada en evidencia científica seleccionada en cuanto a la importancia de mejorar la adherencia al tratamiento y seguimiento a través de diferentes estrategias. Así mismo, provee recomendaciones actualizadas en aspectos críticos del tratamiento del asma leve al grave. Se recomienda, para mejorar la adherencia, el uso de planes personalizados de manejo (1 °C), uso de herramientas a través de teléfonos móviles (1B) y educación (1 °C). Con respecto a la inmunoterapia sublingual solo debe ser indicada a pacientes con asociación con rinitis alérgica, asociada a ácaros y síntomas de asma a pesar del tratamiento adecuado con FEV1 > 70 % (1B). Se recomienda fuertemente en el asma leve (escalón 2 GINA) el uso de broncodilatadores de acción rápida asociados a corticoides inhalados a demanda (1A). En asma grave, se recomienda el uso de la triple terapia inhalada con anticolinérgicos de acción prolongada, beta 2 de acción prolongada y corticoides inhaladas (1B). El uso de biológicos en asma grave está fuertemente indicado en fenotipo T2 con dupilumab (1A), T2 alérgico con omalizumab (1A) y en el T2 eosinofílico con benralizumab, o mepolizumab, con sus características distintivas (1A).

Asthma is a common chronic airway disease in our country, although with high poor control. Some specialists of the Asociación de Alergia e Inmunología Clínica and Asociación Argentina de Medicina Respiratoria have made recommendations for management and treatment of asthma, using a RAND/UCLA modified Delphi consensus methodology, based on GRADE evidence. This document provides recommendations based on specialist opinions about different strategies to improve adherence. Besides, it provides recommendations about critical issues of mild to severe asthma treatment. It´s recommended to improve adherence, personalized control-based management plan (1 °C), mobile devices (1B) and education (1 °C). Sublingual immunotherapy must be prescribed only in patients with allergic rhinitis, mite associated, and persistent symptoms although appropriate treatment with FEV1 > 70 % (1B). Use of fast action bronchodilators associated with inhaled corticosteroids prn in mild asthma (GINA stage 2) has strong recommendation (1A). Use of triple inhaled therapy (long acting anticholinergics, long acting beta 2 agonists and inhaled corticosteroids) is recommended in severe asthma (1B). Biologics has strong recommendations severe asthma: in phenotype T2 with dupilumab (1A), in phenotype allergic T2 with omalizumab (1A) and phenotype eosinophilic T2 with benralizumab or mepolizumab with distinctive characteristic (1A).

Systemic corticosteroids in asthma: A call to action from World Allergy Organization and Respiratory Effectiveness Group.

Systemic corticosteroids (SCS) are a highly effective treatment for acute exacerbations and long-term symptom control in asthma. Long-term SCS use is highly prevalent across all asthma severities, occurring in over 20% of patients with severe or uncontrolled disease globally. It is now well known that exposure to both long-term and repeated acute courses of SCS is associated with a high risk of serious adverse effects (AEs), such as osteoporosis, and metabolic and cardiovascular complications, especially when prescribed onto a background of other corticosteroids. The aim of this call-to-action article, endorsed by the World Allergy Organization and the Respiratory Effectiveness Group, is to review the accumulating evidence on the burden of SCS on patients with asthma and provide an overview of potential strategies for implementing SCS Stewardship. Primary prevention of exacerbations and improvement of asthma control is a key first step in achieving SCS Stewardship, by optimizing maintenance asthma medications and addressing modifiable risk factors, such as adherence and inhaler technique. Other key elements of SCS Stewardship include increasing appropriate specialist referrals for multidisciplinary review, assessment of biomarkers, and consideration of oral corticosteroid-sparing add-on therapies (eg, biologics). In cases where SCS use is deemed clinically justified, it should be tapered to the lowest possible dose. In addition, patients receiving long-term SCS or frequent acute courses should be closely monitored for emergence of SCS-related AEs. Because of the extensive data available on the costly and burdensome AEs associated with SCS use, as well as the range of treatment options now available, there is a need for healthcare providers (HCPs) to carefully evaluate whether the benefits of SCS outweigh the potential harms, to adopt SCS-sparing and Stewardship strategies, and to consider alternative therapies where possible. Development of a structured and collaborative SCS Stewardship approach is urgently required to protect patients from the potential harm of SCS use.

Digital tools in allergy and respiratory care.

Patient care in the allergy and respiratory fields is advancing rapidly, offering the possibility of the inclusion of a variety of digital tools that aim to improve outcomes of care. Impaired access to several health care facilities during the COVID-19 pandemic has considerably increased the appetite and need for the inclusion of e-health tools amongst end-users. Consequently, a multitude of different e-health tools have been launched worldwide with various registration and access options, and with a wide range of offered benefits. From the perspective of both patients and healthcare providers (HCPs), as well as from a legal and device-related perspective, several features are important for the acceptance, effectiveness,and long-term use of e-health tools. Patients and physicians have different needs and expectations of how digital tools might be of help in the care pathway. There is a need for standardization by defining quality assurance criteria. Therefore, the Upper Airway Diseases Committee of the World Allergy Organization (WAO) has taken the initiative to define and propose criteria for quality, appeal, and applicability of e-health tools in the allergy and respiratory care fields from a patient, clinician, and academic perspective with the ultimate aim to improve patient health and outcomes of care.

WAO-ARIA consensus on chronic cough - Part III: Management strategies in primary and cough-specialty care. Updates in COVID-19.

Background: Chronic cough management necessitates a clear integrated care pathway approach. Primary care physicians initially encounter the majority of chronic cough patients, yet their role in proper management can prove challenging due to limited access to advanced diagnostic testing. A multidisciplinary approach involving otolaryngologists and chest physicians, allergists, and gastroenterologists, among others, is central to the optimal diagnosis and treatment of conditions which underly or worsen cough. These include infectious and inflammatory, upper and lower airway pathologies, or gastro-esophageal reflux. Despite the wide armamentarium of ancillary testing conducted in cough multidisciplinary care, such management can improve cough but seldom resolves it completely. This can be due partly to the limited data on the role of tests (eg, spirometry, exhaled nitric oxide), as well as classical pharmacotherapy conducted in multidisciplinary specialties for chronic cough. Other important factors include presence of multiple concomitant cough trigger mechanisms and the central neuronal complexity of chronic cough. Subsequent management conducted by cough specialists aims at control of cough refractory to prior interventions and includes cough-specific behavioral counseling and pharmacotherapy with neuromodulators, among others. Preliminary data on the role of neuromodulators in a proof-of-concept manner are encouraging but lack strong evidence on efficacy and safety. Objectives: The World Allergy Organization (WAO)/Allergic Rhinitis and its Impact on Asthma (ARIA) Joint Committee on Chronic Cough reviewed the recent literature on management of chronic cough in primary, multidisciplinary, and cough-specialty care. Knowledge gaps in diagnostic testing, classical and neuromodulator pharmacotherapy, in addition to behavioral therapy of chronic cough were also analyzed. Outcomes: This third part of the WAO/ARIA consensus on chronic cough suggests a management algorithm of chronic cough in an integrated care pathway approach. Insights into the inherent limitations of multidisciplinary cough diagnostic testing, efficacy and safety of currently available antitussive pharmacotherapy, or the recently recognized behavioral therapy, can significantly improve the standards of care in patients with chronic cough.

WAO-ARIA consensus on chronic cough - Part 1: Role of TRP channels in neurogenic inflammation of cough neuronal pathways.

BACKGROUND: Cough features a complex peripheral and central neuronal network. The function of the chemosensitive and stretch (afferent) cough receptors is well described but partly understood. It is speculated that chronic cough reflects a neurogenic inflammation of the cough reflex, which becomes hypersensitive. This is mediated by neuromediators, cytokines, inflammatory cells, and a differential expression of neuronal (chemo/stretch) receptors, such as transient receptor potential (TRP) and purinergic P2X ion channels; yet the overall interaction of these mediators in neurogenic inflammation of cough pathways remains unclear. OBJECTIVES: The World Allergy Organization/Allergic Rhinitis and its Impact on Asthma (WAO/ARIA) Joint Committee on Chronic Cough reviewed the current literature on neuroanatomy and pathophysiology of chronic cough. The role of TRP ion channels in pathogenic mechanisms of the hypersensitive cough reflex was also examined. OUTCOMES: Chemoreceptors are better studied in cough neuronal pathways compared to stretch receptors, likely due to their anatomical overabundance in the respiratory tract, but also their distinctive functional properties. Central pathways are important in suppressive mechanisms and behavioral/affective aspects of chronic cough. Current evidence strongly suggests neurogenic inflammation induces a hypersensitive cough reflex marked by increased expression of neuromediators, mast cells, and eosinophils, among others. TRP ion channels, mainly TRP V1/A1, are important in the pathogenesis of chronic cough due to their role in mediating chemosensitivity to various endogenous and exogenous triggers, as well as a crosstalk between neurogenic and inflammatory pathways in cough-associated airways diseases.

WAO-ARIA consensus on chronic cough - Part II: Phenotypes and mechanisms of abnormal cough presentation - Updates in COVID-19.

BACKGROUND: Chronic cough can be triggered by respiratory and non-respiratory tract illnesses originating mainly from the upper and lower airways, and the GI tract (ie, reflux). Recent findings suggest it can also be a prominent feature in obstructive sleep apnea (OSA), laryngeal hyperresponsiveness, and COVID-19. The classification of chronic cough is constantly updated but lacks clear definition. Epidemiological data on the prevalence of chronic cough are informative but highly variable. The underlying mechanism of chronic cough is a neurogenic inflammation of the cough reflex which becomes hypersensitive, thus the term hypersensitive cough reflex (HCR). A current challenge is to decipher how various infectious and inflammatory airway diseases and esophageal reflux, among others, modulate HCR. OBJECTIVES: The World Allergy Organization/Allergic Rhinitis and its Impact on Asthma (WAO/ARIA) Joint Committee on Chronic Cough reviewed the current literature on classification, epidemiology, presenting features, and mechanistic pathways of chronic cough in airway- and reflux-related cough phenotypes, OSA, and COVID-19. The interplay of cough reflex sensitivity with other pathogenic mechanisms inherent to airway and reflux-related inflammatory conditions was also analyzed. OUTCOMES: Currently, it is difficult to clearly ascertain true prevalence rates in epidemiological studies of chronic cough phenotypes. This is likely due to lack of standardized objective measures needed for cough classification and frequent coexistence of multi-organ cough origins. Notwithstanding, we emphasize the important role of HCR as a mechanistic trigger in airway- and reflux-related cough phenotypes. Other concomitant mechanisms can also modulate HCR, including type2/Th1/Th2 inflammation, presence or absence of deep inspiration-bronchoprotective reflex (lower airways), tissue remodeling, and likely cough plasticity, among others.

Update on latex allergy: New insights into an old problem.

Despite the efforts made to mitigate the consequences of this disease, natural rubber latex allergy (NRLA) continues to be a global health problem and is still considered one of the main worries in the working environment in many countries throughout the world. Due to thousands of products containing latex, it is not surprising that the current statistics suggest that prevalence remains high among healthcare workers and susceptible patients. In developed countries, reduction in the prevalence of IgE-mediated allergy to latex proteins from gloves may lead to lax attention by health care personnel. On the other hand, this situation is different in developing countries where there is a lack of epidemiological data associated with a deficit in education and awareness of this issue. The aim of this review is to provide an update of the current knowledge and practical recommendations regarding NRLA by allergologists from different parts of the world with experience in this field.

Current situation of allergy education in Mexico and other parts of Latin America.

Allergic diseases are one of the most frequent chronic diseases in the world. It has been established that there is a worldwide epidemic of allergic diseases; therefore, the treatment of allergies should be acknowledged as a worldwide priority and the specialty of allergy should be considered an important field in medicine. Due to the fact that allergic diseases involve many organs, and Allergy and Clinical Immunology is one of the specialties in which physicians may be trained to treat patients of all ages, the subject in medical schools is not always taught as an individual specialty but often as part of another subject such as internal medicine or pediatrics. Certified allergists are an important contribution to health systems, providing the necessary care for patients who have allergic diseases. Undergraduate programs in many universities do not include allergy as a subject, contributing to a lack of knowledge regarding the correct management of allergic diseases. World Health Organization (WHO) recommends 1 allergist per 50,000 people; however, there is an uneven distribution of allergy and clinical immunology specialists. Most practitioners are localized mainly in larger cities and state capitals, while in other regions, specialists are still greatly needed. Support and training systems are required for allergy and clinical immunology specialists to promote continuing education and keep their clinical competence up to date, which will lead to better care for their patients. Increased exposure to the concepts of allergy and clinical immunology diagnosis and treatment in undergraduate education may also potentially lead to an increase in interest in the field of allergy and clinical immunology among physicians in training. This review will approach allergy education in Mexico and other parts of Latin America.

Allergy and coronavirus disease (COVID-19) international survey: Real-life data from the allergy community during the pandemic.

BACKGROUND: The COVID-19 outbreak brought an unprecedented challenge to the world. Knowledge in the field has been increasing exponentially and the main allergy societies have produced guidance documents for better management of allergic patients during this period. However, few publications so far have provided real-life data from the allergy community concerning allergy practice during the COVID-19 outbreak. Therefore, we proposed an international survey on the management of allergic patients during the current pandemic. METHODS: We performed an online survey undertaken to reach out the worldwide allergy community by e-mail and social media. The web-based questionnaire contained 24 questions covering demographic data from the participants, clinical practice during this period, and questions related to the new international classification and coding tools addressed for COVID-19. It was circulated for 8 weeks and had anonymous and volunteer context. RESULTS: Data are presented for 635 participants from 78 countries of all continents. Allergists with long-term professional experience were the main audience. As expected, we received many responses as "I have no data" or "I don't know" to the questions of the survey. However, most with more experience on managing allergic patients during the pandemic agreed that patients suffering from allergic or hypersensitivity conditions have no increased risk of contracting COVID-19 or developing SARS CoV-2. Also, participants mentioned that none of the allergy treatments (inhaled corticosteroids, allergen immunotherapy, biological agents) increased the risk of contracting COVID-19 infection including severe presentations. CONCLUSION: The data presented are a starting point in the process of getting feedback on all the recommendations provided by the allergy societies; it could also be the basis of new strategies to support health professionals while new COVID-19 specific treatments and vaccines are being explored. The information here presented intends to be helpful to the community but represents a course of action in a highly specific situation due to the state of emergency, and it should be helpful to health systems.

COVID-19, asthma, and biological therapies: What we need to know.

Managing patients with severe asthma during the coronavirus pandemic and COVID-19 is a challenge. Authorities and physicians are still learning how COVID-19 affects people with underlying diseases, and severe asthma is not an exception. Unless relevant data emerge that change our understanding of the relative safety of medications indicated in patients with asthma during this pandemic, clinicians must follow the recommendations of current evidence-based guidelines for preventing loss of control and exacerbations. Also, with the absence of data that would indicate any potential harm, current advice is to continue the administration of biological therapies during the COVID-19 pandemic in patients with asthma for whom such therapies are clearly indicated and have been effective. For patients with severe asthma infected by SARS-CoV-2, the decision to maintain or postpone biological therapy until the patient recovers should be a case-by-case based decision supported by a multidisciplinary team. A registry of cases of COVID-19 in patients with severe asthma, including those treated with biologics, will help to address a clinical challenge in which we have more questions than answers.

Pharmacokinetics and safety of bilastine in children aged 6 to 11 years with allergic rhinoconjunctivitis or chronic urticaria.

Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults and children aged ≥ 6 years. Pharmacokinetic data for children aged 6-11 years were extracted post hoc from a study in which children (2-11 years) with allergic rhinoconjunctivitis or urticaria received oral bilastine (10 mg/day). Maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC) data were compared with adult pharmacokinetic data from seven clinical studies (bilastine 20 mg/day). Safety data for children aged 6-11 years were extracted post hoc from a phase III randomized controlled trial of children (2-11 years) with allergic rhinoconjunctivitis or chronic urticaria receiving once-daily bilastine 10 mg or placebo for 12 weeks. Exposure and Cmax values were similar for children (6-11 years) and adults: median pediatric/adult ratios for AUC0-24 and Cmax were 0.93 and 0.91, respectively. There was no significant difference in the incidence of treatment-emergent adverse in children (6-11 years) receiving bilastine 10 mg or placebo.Conclusion: Pharmacokinetic and safety analyses in children aged 6-11 years support the suitability of the pediatric dose of bilastine 10 mg and confirm that the safety profiles of bilastine and placebo are similar.What is Known:• Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults (20 mg/day) and children aged ≥ 6 years (10 mg/day).• An ontogenic model based on adult data and pharmacokinetic/pharmacodynamic simulations supported the selection of a bilastine dose of 10 mg/day in children aged 2-11 years. Bilastine 10 mg/day was shown to have a safety profile similar to that of placebo in a large phase III randomized clinical trial in children aged 2-11 years.What is New:• As bilastine is approved in Europe for children aged ≥6 years, the current study reports the results of two post hoc analyses of pharmacokinetic and safety data in children aged 6-11 years.• Analysis of pharmacokinetic and safety data in children aged 6-11 years supports the suitability of the pediatric dose of bilastine 10 mg and confirms that its safety profile is similar to that of placebo.

Helsinki by nature: The Nature Step to Respiratory Health.

BACKGROUND: The Nature Step to Respiratory Health was the overarching theme of the 12th General Meeting of the Global Alliance against Chronic Respiratory Diseases (GARD) in Helsinki, August 2018. New approaches are needed to improve respiratory health and reduce premature mortality of chronic diseases by 30% till 2030 (UN Sustainable Development Goals, SDGs). Planetary health is defined as the health of human civilization and the state of the natural systems on which it depends. Planetary health and human health are interconnected, and both need to be considered by individuals and governments while addressing several SDGs. RESULTS: The concept of the Nature Step has evolved from innovative research indicating, how changed lifestyle in urban surroundings reduces contact with biodiverse environments, impoverishes microbiota, affects immune regulation and increases risk of NCDs. The Nature Step calls for strengthening connections to nature. Physical activity in natural environments should be promoted, use of fresh vegetables, fruits and water increased, and consumption of sugary drinks, tobacco and alcohol restricted. Nature relatedness should be part of everyday life and especially emphasized in the care of children and the elderly. Taking "nature" to modern cities in a controlled way is possible but a challenge for urban planning, nature conservation, housing, traffic arrangements, energy production, and importantly for supplying and distributing food. Actions against the well-known respiratory risk factors, air pollution and smoking, should be taken simultaneously. CONCLUSIONS: In Finland and elsewhere in Europe, successful programmes have been implemented to reduce the burden of respiratory disorders and other NCDs. Unhealthy behaviour can be changed by well-coordinated actions involving all stakeholders. The growing public health concern caused by NCDs in urban surroundings cannot be solved by health care alone; a multidisciplinary approach is mandatory.

[2017 Brussels Agreement for Latin America: an initiative of the GARD and Slaai]. / El Acuerdo Bruselas 2017 para Latinoamérica: una iniciativa de la GARD y Slaai.

The Global Alliance against Chronic Respiratory Diseases (GARD) is a network of organizations coordinated by the World Health Organization. It is a voluntary alliance of national and international organizations, institutions and agencies with global scope that are committed with actions to improve access to prevention, care and essential medications. On its last annual meeting, celebrated in Brussels (Belgium) in September 2017, the need for actions and representation to be grouped by geographic regions was discussed. There are several successful programs regarding morbidity and mortality control of these diseases, and others that improve cost-benefit and quality of life. Thus, SLaai proposes to contribute to the diffusion and knowledge of chronic respiratory diseases magnitude and risk factors, to identify successful programs in Latin America in order for them to be replicated in the region and to generate strategic alliances for the strengthening of joint actions.

La Alianza Global contra las Enfermedades Respiratorias Crónicas es una red de organizaciones coordinadas por la Organización Mundial de la Salud. Es una coalición voluntaria de organizaciones, instituciones y organismos nacionales e internacionales con alcance mundial comprometidos con acciones para mejorar el acceso a la prevención, asistencia y medicamentos esenciales. Durante su última reunión anual, efectuada en Bruselas, Bélgica, en septiembre de 2017, emergió la necesidad de agrupar acciones y representación por regiones geográficas. Existen diferentes programas exitosos en el control de la morbimortalidad de estas enfermedades y otros que mejoran el costo-beneficio y la calidad de vida. Así, desde SLaai se propone contribuir a la difusión y conocimiento de la magnitud y factores de riesgo en enfermedades respiratorias crónicas, identificar programas exitosos de Latinoamérica para ser replicados en la región y generar convenios estratégicos para el fortalecimiento de acciones conjuntas.

Clinical characteristics and comorbidities of elderly asthmatics who attend allergy clinics.

BACKGROUND: To date, few studies have focused on the clinical and allergic characteristics of asthma in the elderly, defined as asthma in people aged 60 or over. Thus, we propose to identify and study the clinical and allergic characteristics and comorbidities of patients with asthma among the elderly. METHODS: A retrospective, observational, descriptive study was developed in five clinics and hospitals in Argentina. Allergy Physicians analyzed their patients' medical records in 2014 and included those adults over the age of 60, who had been diagnosed with asthma according to the GINA guidelines. Clinical and allergic characteristics were analyzed. RESULTS: A total of 152 patients diagnosed with asthma, of whom 73% were women and 11% ex-smokers, were included in this study, with a mean age of 66 years. Only 10.5% of the participants had onset asthma past the age of 60. Regarding asthma severity, 74.3% were diagnosed with moderate persistent asthma, and 7.2% with severe persistent asthma. Eighty-four percent of the patients were treated with an inhaled corticosteroid (ICS) along with a long-acting ß 2-adrenergic agent (LABA). More than half of the patients had two or more comorbidities simultaneously. Allergic comorbidities were the most frequent comorbidities, followed by arterial hypertension. Among allergic comorbidities, most patients presented allergies at the nasal level. There were no significant differences between the subpopulations of patients with late-onset asthma (LOA) and asthma with onset before the age of 60, i.e. early onset asthma (EOA) in most of their clinical characteristics. However, it was observed that EOA accounted for a higher percentage of patients with nasal allergies as compared to LOA (71% vs 46%, p <  0.05).It is worth mentioning that almost half of the patients with LOA had allergies at the nasal level. CONCLUSION: These results may provide a better understanding of the clinical characteristics of asthma in the elderly in Argentina, thus, enabling the development of future therapeutic strategies and a better quality of life for our elderly asthma patients.

Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases.

BACKGROUND: Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10-mg dose of bilastine in children aged 2 to <12 years provided an equivalent systemic exposure as 20 mg in adults. The current study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria. METHODS: In this phase III, multicentre, double-blind study, children were randomized to once-daily treatment with bilastine 10-mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks. Safety evaluations included treatment-emergent adverse events (TEAEs), laboratory tests, cardiac safety (ECG recordings) and somnolence/sedation using the Pediatric Sleep Questionnaire (PSQ). RESULTS: The primary hypothesis of non-inferiority between bilastine 10 mg and placebo was demonstrated on the basis of a near-equivalent proportion of children in each treatment arm without TEAEs during 12 weeks' treatment (31.5 vs. 32.5%). No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for TEAEs or related TEAEs, ECG parameters and PSQ scores. The majority of TEAEs were mild or moderate in intensity. TEAEs led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo. CONCLUSIONS: Bilastine 10 mg had a safety and tolerability profile similar to that of placebo in children aged 2 to <12 years with allergic rhinoconjunctivitis or chronic urticaria.

A patient preference study that evaluated fluticasone furoate and mometasone furoate nasal sprays for allergic rhinitis.

BACKGROUND: Corticosteroid nasal sprays are the mainstay of treatment for allergic rhinitis. These sprays have sensory attributes such as scent and/or odor, taste and aftertaste, and run down the throat and/or the nose, which, when unpleasant, can affect patient preference for, and compliance with, treatment. OBJECTIVE: This study examined patient preference for fluticasone furoate nasal spray (FFNS) or mometasone furoate nasal spray (MFNS) based on their sensory attributes after administration in patients with allergic rhinitis. METHODS: This was a multicenter, randomized, double-blind, cross-over study. Patient preferences were determined by using three questionnaires (Overall Preference, Immediate Attributes, and Delayed Attributes). RESULTS: Overall, 56% of patients stated a preference for FFNS versus 32% for MFNS (p < 0.001); the remaining 12% stated no preference. More patients stated a preference for FFNS versus MFNS for the attributes of "less drip down the throat" (p < 0.001), "less run out of the nose" (p < 0.05), "more soothing" (p < 0.05), and "less irritating" (p < 0.001). More patients responded in favor of FFNS versus MFNS for the immediate attributes, "run down the throat" (p < 0.001), and "run out of the nose" (p < 0.001), and, in the delayed attributes, "run down the throat" (p < 0.001), "run out of the nose" (p < 0.01), "presence of aftertaste" (p < 0.01), and "no nasal irritation" (p < 0.001). CONCLUSION: Patients with allergic rhinitis preferred FFNS versus MFNS overall and based on a number of individual attributes, including "less drip down the throat," "less run out of the nose," and "less irritating." Greater preference may improve patient adherence and thereby improve symptom management of the patient's allergic rhinitis.

Asthma in Latin America.

Consistent with the diversity of Latin America, there is profound variability in asthma burden among and within countries in this region. Regional variation in asthma prevalence is likely multifactorial and due to genetics, perinatal exposures, diet, obesity, tobacco use, indoor and outdoor pollutants, psychosocial stress and microbial or parasitic infections. Similarly, non-uniform progress in asthma management leads to regional variability in disease morbidity. Future studies of distinct asthma phenotypes should follow-up well-characterised Latin American subgroups and examine risk factors that are unique or common in Latin America (eg, stress and violence, parasitic infections and use of biomass fuels for cooking). Because most Latin American countries share the same barriers to asthma management, concerted and multifaceted public health and research efforts are needed, including approaches to curtail tobacco use, campaigns to improve asthma treatment, broadening access to care and clinical trials of non-pharmacological interventions (eg, replacing biomass fuels with gas or electric stoves).

Asthma in the elderly: what we know and what we have yet to know.

In the past, asthma was considered mainly as a childhood disease. However, asthma is an important cause of morbidity and mortality in the elderly nowadays. In addition, the burden of asthma is more significant in the elderly than in their younger counterparts, particularly with regard to mortality, hospitalization, medical costs or health-related quality of life. Nevertheless, asthma in the elderly is still been underdiagnosed and undertreated. Therefore, it is an imperative task to recognize our current challenges and to set future directions. This project aims to review the current literature and identify unmet needs in the fields of research and practice for asthma in the elderly. This will enable us to find new research directions, propose new therapeutic strategies, and ultimately improve outcomes for elderly people with asthma. There are data to suggest that asthma in older adults is phenotypically different from young patients, with potential impact on the diagnosis, assessment and management in this population. The diagnosis of AIE in older populations relies on the same clinical findings and diagnostic tests used in younger populations, but the interpretation of the clinical data is more difficult. The challenge today is to encourage new research in AIE but to use the existing knowledge we have to make the diagnosis of AIE, educate the patient, develop a therapeutic approach to control the disease, and ultimately provide a better quality of life to our elderly patients.