Consensus on mild asthma management: results of a modified Delphi study.

OBJECTIVE: In order to understand the role of regular controller inhaled corticosteroids (ICS) versus as-needed ICS-formoterol in managing mild asthma, we performed a modified Delphi procedure. METHODS: Opinions from 16 respiratory experts to three surveys and during a virtual scientific workshop helped to develop final consensus statements (pre-defined as 70% agreement). RESULTS: Thirteen participants completed all rounds (response rate 81%). At the end of the procedure, there was final consensus on: regular daily ICS being the recommended treatment approach in mild persistent asthma, with better symptom control and robust long-term clinical data compared with as-needed ICS-formoterol (85%); to avoid noncompliance, frequently seen in mild asthma patients, regular ICS dosing should be accompanied by ongoing education on treatment adherence (100%); treatment aims should be targeting asthma control (92%) and reduction of exacerbation risk (85%). No consensus was reached on whether GINA or national guidelines most influence prescribing decisions. CONCLUSIONS: It is important to encourage patients to be adherent and to target both asthma control and exacerbation risk reduction. There is robust clinical evidence to support proactive regular dosing with ICS controller therapy plus as-needed short-acting beta-agonists for the management of patients with mild asthma.

Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence

The selection of pharmacotherapy for patients with allergic rhinitis aims to control the disease and depends on many factors. Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines have considerably improved the treatment of allergic rhinitis. However, there is an increasing trend toward use of real-world evidence to inform clinical practice, especially because randomized controlled trials are often limited with regard to the applicability of results. The Contre les Maladies Chroniques pour un Vieillissement Actif (MACVIA) algorithm has proposed an allergic rhinitis treatment by a consensus group. This simple algorithm can be used to step up or step down allergic rhinitis treatment. Next-generation guidelines for the pharmacologic treatment of allergic rhinitis were developed by using existing GRADE-based guidelines for the disease, real-world evidence provided by mobile technology, and additive studies (allergen chamber studies) to refine the MACVIA algorithm.

Key factors associated with uncontrolled asthma - the Asthma Control in Latin America Study.

Objective: This study aimed to estimate asthma control at specialist treatment centers in four Latin American countries and assess factors influencing poor asthma control.Methods: Patients aged ≥12 years with an asthma diagnosis and asthma medication prescription, followed at outpatient specialist centers in Argentina, Chile, Colombia, and Mexico, were included. The study received all applicable ethical approvals. The Asthma Control Test (ACT) was used to classify patients as having controlled (ACT 20-25) or uncontrolled (ACT ≤19) asthma. Frequency and statistical tests were used to assess the association between hospital admissions/exacerbations/emergency department (ED) visits and uncontrolled asthma; multivariate logistic regression was used to assess the association of uncontrolled asthma with clinical/demographic variables.Results: A total of 594 patients were included. Overall controlled-asthma prevalence was 43.4% (95% confidence interval [CI]: 39.0, 47.4). Patients with uncontrolled asthma were more likely to be women (adjusted odds ratio [aOR]: 1.85; p = 0.003), non-white (aOR: 2.14; p < 0.001), obese (aOR: 1.71; p = 0.036), to have a low monthly family income (aOR: 1.75; p = 0.004), to have severe asthma (aOR:1.59; p = 0.26), and, compared with patients with controlled asthma, to have a higher likelihood of asthma exacerbations (34.5% vs. 15.9%; p < 0.001), hospital admissions (6.9% vs. 3.1%; p = 0.042), and ED visits (34.5% vs. 15.9%; p < 0.001) due to asthma.Conclusions: Even in specialist ambulatory services, fewer than half of patients were classified as having controlled asthma. The proportion of uncontrolled patients varied according to clinical and demographic variables.

Asthma severity in four countries of Latin America.

BACKGROUND: In Latin America, there is scarce information about severe asthma (SA) according to the ERS/ATS 2014 criteria. This study aimed to compare the demographic, socio, clinical characteristics, treatment, and use of healthcare resources between SA and non-severe asthma (NSA) patients in Argentina, Colombia, Chile and Mexico. METHODS: A cross-sectional study was conducted including 594 asthma patients from outpatient specialized sites. A descriptive analysis was performed comparing SA patients and NSA. Chi-square and Mann Whitney tests were used to assess associations between asthma severity and outcome variables. RESULTS: Using ERS/ATS 2014 criteria, 31.0% of the patients were identified as SA. SA patients were older at diagnosis (mean age 31.64 years vs 24.71 years, p < 0.001) and had higher proportion of uncontrolled asthma than the NSA patients (64.1% vs 53.2%, p < 0.001). SA patients reported a significantly higher proportion of both hospital admission and emergency room (ER) visits due to asthma in the last year, compared with NSA patients, 8.7% vs. 3.7% (p = 0.011) and 37.0% vs. 21.7% (p < 0.001), respectively. CONCLUSIONS: SA patients were older, had greater proportions in some comorbidities and experienced increased healthcare utilization. Also, our results showed that even in patients using the last steps of treatment (GINA step 4 or 5), there was still a higher proportion of uncontrolled disease.

[MASK (Mobile Airways Sentinel Network), a mobile App with ARIA's comprehensive solution in Spanish-speaking countries]. / MASK (Mobile Airways Sentinel Network), una app móvil con la solución integral de ARIA en países de habla hispana.

Although there are high quality clinical guidelines about allergic rhinitis, many patients receive deficient treatment, partly due to the high level of self-medication. MASK (Mobile Airways Sentinel Network) is an integral part of a project against chronic diseases which it is focused on active and healthy aging and is supported by the European Union. It forms the third phase of ARIA (Allergic Rhinitis and its Impact on Asthma) in which, through a mobile app on a smart device, the purpose is to guide patients in the control of their multimorbidity, allergic rhinitis or conjunctivitis, or asthma. The "Allergy Diary" app by MACVIA-ARIA is free and it is available for Android and iOS; on it, patients indicate how unpleasant the symptoms are on a daily basis through five screens with an analogous visual scale; two more screens were recently added (sleep affectation). With the app, it is also possible to download the information of the "Allergy Diary" on the physician's computer through a QR code at the moment of the medical consultation. In this article, we review the first year of experience in Spain, Mexico and Argentina, where the Spanish version is used.

Aunque existen guías clínicas de alta calidad sobre rinitis alérgica, numerosos pacientes reciben tratamiento deficiente, en parte debido al alto grado de automedicación. MASK (Mobile Airways Sentinel Network) forma parte integral de un proyecto apoyado por la Unión Europea contra las enfermedades crónicas y enfocado al envejecimiento activo y saludable. Constituye la tercera fase de ARIA (Allergic Rhinitis and its Impact on Asthma), en la cual mediante una aplicación móvil en un dispositivo inteligente se intenta guiar al paciente en el control de su multimorbilidad, rinitis o conjuntivitis alérgicas o asma. La aplicación Diario de Alergia por MACVIA-ARIA es gratuita y está disponible para Android e iOS; en ella, los pacientes indican diariamente cuánto les molestan los síntomas a través de cinco pantallas con una escala visual análoga; recientemente se agregaron dos pantallas más (afectación del sueño). La aplicación también permite descargar los datos del "Diario de alergias" en la computadora del médico en el momento de la consulta a través de un código QR. En este artículo reseñamos el primer año de experiencia en España, México y Argentina, que utilizan la versión española.

[Environmental intervention in respiratory disease]. / Intervención ambiental en las enfermedades respiratorias.

In recent years there has been a significant increase in the prevalence of allergic diseases despite advances in the understanding of the pathogenesis, the dissemination of guidelines for its management and the emergence of new drugs. The reasons for this increase are not fully established, but it is suggested that multiple environmental factors may be involved. Inhaled air contains numerous harmful agents in addition to environmental allergens. The main immediate respiratory clinical expression after inhaling this contaminated air is asthma and rhinitis. The activity of human beings has altered the outdoor environment by the emission of multiple pollutants and has produced an increasing climate change. It also has a notable impact on the development of respiratory pathology and the modification of air quality. The bibliography on the subject of environmental control is very broad and sometimes difficult to interpret. In order to be able to make precise, valid and simple indications for patients to accomplish with, four scientific societies of the Argentine Republic that deal with this type of diseases, have elaborated a document that contains information of easy access to all medical personal involved in the treatment of patients with asthma and / or rhinitis, that provides practical measures for the patients and the different public health systems about unmet needs in this complex issue.

En los últimos años hubo un aumento significativo en la prevalencia de las enfermedades alérgicas pese a los avances en la comprensión de la patogénesis, la divulgación de guías para su control y tratamiento y la aparición de nuevos fármacos. La razón para este aumento no está totalmente establecida, pero se considera que múltiples factores ambientales podrían estar involucrados en ello. El aire inspirado contiene numerosos agentes nocivos además de alérgenos ambientales; el asma y la rinitis alérgica son las principales expresiones clínicas respiratorias inmediatas posteriores a su inhalación. En la antropósfera, el entorno de la superficie terrestre habitada por los humanos, se han alterado los equilibrios naturales por la emisión de múltiples sustancias y se ha producido un creciente cambio climático. Este fenómeno global influye en la calidad del aire y consecuentemente en el desarrollo de enfermedades respiratorias. Dado que la bibliografía sobre el tema del control ambiental es muy amplia, y en ocasiones difícil de interpretar para poder realizar indicaciones precisas, válidas y sencillas de cumplir por parte de los pacientes, cuatro sociedades científicas de la República Argentina, dedicadas a este tipo de enfermedades, elaboraron un documento con información de fácil acceso a todo profesional médico que trate asma y/o rinitis, que expone medidas prácticas para los enfermos y alerta a los distintos actores involucrados en la salud pública acerca de las necesidades insatisfechas en este tema tan complejo, a fin de poder elaborar una agenda para su posible resolución.

[MASK (Mobile Airways Sentinel Network). ARIA's comprehensive solution for mobile app for the multimorbidity of allergic rhinitis and asthma]. / MASK (Mobile Airways Sentinel Network). La solución integral de ARIA por app móvil para la multimorbilidad de rinitis alérgica y asma.

The vast majority of patients with allergic rhinitis (AR) do not receive the proper management which is recommended by the guidelines, but they frequently self-medicate. MASK (Mobile Airways Sentinel Network) is an integral part of a project that is supported by the European Union against chronic diseases and focused on active and healthy aging. MASK represents the third phase of ARIA (Allergic Rhinitis and its Impact on Asthma), in which, by using a mobile application in a smart device, the objective is to guide the patient in the control of his/her multi-morbidity, AR and/or allergic conjunctivitis (AC) and/or asthma. The mobile app Allergy Diary by MACVIA-ARIA is free and it is available for both Android and iOS platforms. After it is downloaded to the patient's cell phone, it first requests some information about the patient's profile, allergic pathologies and medication; afterwards, through a visual analog scale, the patient is invited to determine the degree of affectation in the nose, eyes, and bronchi, and its influence on their productivity at work / school. After analyzing the data generated by filling the Allergy Diary, it became clear there is a new clinical entity: allergic rhinitis+ allergic conjunctivitis +asthma, with greater effect; in addition to a high level of self-medication: in general, the patient takes medication on days when symptoms are present. The app has already been deployed in 23 countries, including several Spanish-speaking countries.

La mayoría de los pacientes con rinitis alérgica no recibe el manejo idóneo, sino que se automedica. MASK (Mobile Airways Sentinel Network) forma parte integral de un proyecto apoyado por la Unión Europea contra las enfermedades crónicas y enfocado al envejecimiento activo y saludable. Constituye la tercera fase de ARIA (Allergic Rhinitis and its Impact on Asthma), en la cual mediante una aplicación móvil en un dispositivo inteligente se intenta guiar al paciente en el control de su multimorbilidad, rinitis o conjuntivitis alérgicas o asma. La aplicación Diario de Alergia por MACVIA-ARIA es gratuita y está disponible para Android e iOS. Al descargarla al celular del paciente, a este se le piden datos de su perfil, patologías alérgicas y medicación; posteriormente, mediante una escala visual analógica se le invita a determinar el grado de afectación en nariz, ojos y bronquios y su influencia sobre su productividad laboral/escolar. Con los datos del Diario de Alergia se observa que existe un nuevo patrón de presentación: rinitis alérgica + conjuntivitis alérgica + asma, con mayor afectación, así como un alto nivel de automedicación: en general, el paciente toma medicación cuando presenta síntomas. La app se ha desplegado en 23 países, incluyendo varios países hispanohablantes.

Intervención ambiental en las enfermedades respiratorias / Environmental intervention in respiratory disease

En los últimos años hubo un aumento significativo en la prevalencia de las enfermedades alérgicas pese a los avances en la comprensión de la patogénesis, la divulgación de guías para su control y tratamiento y la aparición de nuevos fármacos. La raz ón para este aumento no está totalmente estable cida, pero se considera que múltiples factores ambientales podrían estar involucrados en ello. El aire inspirado contiene numerosos agentes nocivos además de alérgenos ambientales; el asma y la rinitis alérgica son las principales expresiones clínicas respiratorias inmediatas posteriores a su inhalación. En la antropósfera, el entorno de la superficie terrestre habitada por los humanos, se han alterado los equilibrios naturales por la emisión de múltiples sustancias y se ha producido un creciente cambio climático. Este fenómeno global influye en la calidad del aire y consecuentemente en el desarrollo de enfermedades respiratorias. Dado que la bibliografía sobre el tema del control ambiental es muy amplia, y en ocasiones difícil de interpretar para poder realizar indicaciones precisas, válidas y sencillas de cumplir por parte de los pacientes, cuatro sociedades científicas de la República Argentina, dedicadas a este tipo de enfermedades, elaboraron un documento con información de fácil acceso a todo profesional médico que trate asma y/o rinitis, que expone medidas prácticas para los enfermos y alerta a los distintos actores involucrados en la salud pública acerca de las necesidades insatisfechas en este tema tan complejo, a fin de poder elaborar una agenda para su posible resolución.

In recent years there has been a significant increase in the prevalence of allergic diseases despite advances in the understanding of the pathogenesis, the dissemination of guidelines for its management and the emergence of new drugs. The reasons for this increase are not fully established, but it is suggested that multiple environmental factors may be involved. Inhaled air contains numerous harmful agents in addition to environmental allergens. The main immediate respiratory clinical expression after inhaling this contaminated air is asthma and rhinitis. The activity of human beings has altered the outdoor environment by the emission of multiple pollutants and has produced an increasing climate change. It also has a notable impact on the development of respiratory pathology and the modification of air quality. The bibliography on the subject of environmental control is very broad and sometimes difficult to interpret. In order to be able to make precise, valid and simple indications for patients to accomplish with, four scientific societies of the Argentine Republic that deal with this type of diseases, have elaborated a document that contains information of easy access to all medical personal involved in the treatment of patients with asthma and / or rhinitis, that provides practical measures for the patients and the different public health systems about unmet needs in this complex issue.

[Executive Summary of ARIA 2019: Integrated care pathways for allergic rhinitis in Argentina, Spain and Mexico]. / Resumen ejecutivo de ARIA 2019: Vías integradas de atención para la rinitis alérgica en Argentina, España y México.

The health and economic impact of allergic diseases are increasing rapidly, and changes in management strategies are required. Its influence reduces the capacity of work and school performance by at least a third. The ICPs of the airways (integrated care pathways for respiratory diseases) are structured multidisciplinary healthcare plans, promoting the recommendations of the guidelines in local protocols and their application to clinical practice. This document presents an executive summary for Argentina, Mexico, and Spain. Next-generation ARIA guidelines are being developed for the pharmacological treatment of allergic rhinitis (AR), using the GRADE-based guidelines for AR, tested with real-life evidence provided by mobile technology with visual analogue scales. It is concluded that in the AR treatment, H1-antihistamines are less effective than intranasal corticosteroids (INCS), in severe AR the INCS represent the first line of treatment, and intranasal combination INCS + anti-H1 is more effective than monotherapy. However, according to the MASK real-life observational study, patients have poor adherence to treatment and often self-medicate, according to their needs.

El impacto sanitario y económico de las enfermedades alérgicas está aumentando rápidamente y se necesitan cambios en las estrategias para su manejo. Su influencia reduce al menos en un tercio la capacidad de desempeño laboral y escolar. Los ICP (Vías Integradas de Atención) de las enfermedades de las vías respiratorias son planes de atención estructurados y multidisciplinarios, que promueven las recomendaciones de las guías en protocolos locales y su aplicación a la práctica clínica. En este documento se presenta un resumen ejecutivo para Argentina, México y España. Se desarrollan las guías ARIA de próxima generación para el tratamiento farmacológico de la rinitis alérgica (RA) utilizando las pautas basadas en GRADE para RA, probadas con evidencia de la vida real proporcionada por tecnología móvil basada en escalas visuales analógicas. Se concluye que en el tratamiento de la RA, los antihistamínicos anti-H1 son menos efectivos que los corticoides intranasales (CINS), que en la rinitis gravelos CINS representan la primera línea de tratamiento, y que la combinación intranasal de CINS + anti-H1 es más eficaz que la monoterapia. Sin embargo, según el estudio MASK observacional en vida real, los pacientes tienen pobre adherencia al tratamiento y frecuentemente se automedican de acuerdo con sus necesidades.

Prevalencia y características clínicas del asma en adultos jóvenes en zonas urbanas de Argentina / Prevalence and Features of Asthma in Young Adults in Urban Areas of Argentina

Objetivo: Estimar la carga del asma en la población adulta joven en zonas urbanas de Argentina. Diseño: Se realizó una encuesta telefónica a nivel nacional en sujetos de 20 a 44 años en áreas urbanas de Argentina. Se utilizó el cuestionario de la European Community Respiratory Health Survey. El asma se definió como ataque en el último año o uso de medicamentos para el asma. Resultados: Mil quinientos veintiún sujetos fueron encuestados (62,4% mujeres, edad media 33 años). Noventa y uno fueron clasificados como asmáticos (5,9%, IC 95% 4,7-7,1). La prevalencia ajustada por edad, sexo y nivel educativo fue de 6,4% (IC 95% 5,1-7,7). El porcentaje de sibilancia fue de un 13,9% (IC 95% 15,6-12,2) y el de diagnóstico médico de asma, de un 9,5% (IC 95% 8,0-11,0). Entre los diagnósticos (n = 154), el 71,3% realizó una espirometría y el 51,9% de los tratados (n = 77) utilizaba medicamentos diariamente y un 46,8% como rescate. De los que reportaron algún ataque en el último año (n = 60), un 55% tuvieron una visita a Urgencias y un 23,3% fueron hospitalizados. El asma se asoció con rinitis (OR 11,1; IC 95% 6,2-19,9) e historia familiar (OR 3,6; IC 95% 2,3-5,5). Conclusión: La prevalencia de asma en adultos jóvenes en Argentina es similar a la de Europa. Aunque los ataques y las admisiones fueron comunes, el uso regular de los medicamentos fue informado por la mitad de los tratados. Los resultados pueden ser útiles para otros países de América Latina (AU)

Objective: To investigate the burden of asthma in a young adult population in urban areas of Argentina. Design: A nationwide telephone survey in subjects aged 20-44 years was performed in urban areas in Argentina. The European Community Respiratory Health Survey questionnaire was used. Asthma was defined as an exacerbation in the last year or use of asthma medications. Results: In total, 1,521 subjects responded (62.4% females, mean age 33 years), of whom 91 were classified as asthmatics (5.9%, 95% CI 4.7-7.1). Prevalence adjusted for age, sex and education level was 6.4% (95% CI 5.1-7.7). Wheezing was reported by 13.9% (95% CI 15.6-12.2) and a diagnosis of asthma by 9.5% (95% CI 8.0-11.0). Among individuals with a diagnosis of asthma (n=154), 71.3% had undergone spirometry. Among those treated (n=77), 51.9% used medications daily and 46.8% as a rescue measure. Of those reporting an exacerbation in the last year (n=60), 55% had attended an emergency department and 23% were admitted. Asthma was associated with rhinitis (OR 11.1, 95% CI 6.2-19.9) and family history (OR 3.6, 95% CI 2.3-5.5). Conclusion: Asthma prevalence in young adults in Argentina is similar to Europe. Although attacks and admissions were common, regular use of medications was reported by half of those treated. These results may be useful for other Latin American countries (AU)

Prevalence and Features of Asthma in Young Adults in Urban Areas of Argentina. / Prevalencia y características clínicas del asma en adultos jóvenes en zonas urbanas de Argentina.

OBJECTIVE: To investigate the burden of asthma in a young adult population in urban areas of Argentina. DESIGN: A nationwide telephone survey in subjects aged 20-44 years was performed in urban areas in Argentina. The European Community Respiratory Health Survey questionnaire was used. Asthma was defined as an exacerbation in the last year or use of asthma medications. RESULTS: In total, 1,521 subjects responded (62.4% females, mean age 33 years), of whom 91 were classified as asthmatics (5.9%, 95% CI 4.7-7.1). Prevalence adjusted for age, sex and education level was 6.4% (95% CI 5.1-7.7). Wheezing was reported by 13.9% (95% CI 15.6-12.2) and a diagnosis of asthma by 9.5% (95% CI 8.0-11.0). Among individuals with a diagnosis of asthma (n=154), 71.3% had undergone spirometry. Among those treated (n=77), 51.9% used medications daily and 46.8% as a rescue measure. Of those reporting an exacerbation in the last year (n=60), 55% had attended an emergency department and 23% were admitted. Asthma was associated with rhinitis (OR 11.1, 95% CI 6.2-19.9) and family history (OR 3.6, 95% CI 2.3-5.5). CONCLUSION: Asthma prevalence in young adults in Argentina is similar to Europe. Although attacks and admissions were common, regular use of medications was reported by half of those treated. These results may be useful for other Latin American countries.

[ARIA 2016 executive summary: Integrated care pathways for predictive medicine throughout the life cycle in Argentina]. / Resumen ejecutivo de ARIA 2016: vías integradas de atención para la medicina predictiva a lo largo del ciclo de vida en Argentina.

The ARIA initiative was started during a World Health Organization workshop in 1999. The initial goals were to propose a new classification for allergic rhinitis, to promote the concept of multi-morbidity in asthma and rhinitis and to develop guidelines with stakeholders for world-wide use. ARIA is now focused on the implementation of emerging technologies for individualized and predictive medicine. MASK: MACVIA-Aria Sentinel Network uses mobile technology to develop care pathways that enable management by a multidisciplinary group or by patients themselves. An App for iOS and Android uses a visual analogue scale to assess symptom control and work productivity, as well as a clinical decision support system; it is associated with an interoperable tablet for health professionals. The escalation strategy uses recommendations of the European Innovation Partnership on Active and Healthy Ageing. The aim of ARIA's new approach is to provide an active and healthy life to people affected by rhinitis, regardless of age, gender or socioeconomic status, in order to reduce social and health inequalities caused by the disease.

La iniciativa ARIA (Rinitis Alérgica y su Impacto en el Asma) se inició durante un taller de la Organización Mundial de la Salud en 1999. Los objetivos iniciales fueron proponer una nueva clasificación de rinitis alérgica, promover el concepto de multimorbilidad en asma y rinitis y desarrollar guías con todas las partes interesadas para su en todos los países y poblaciones. ARIA, difundida e implementada en más de 70 naciones, ahora se centra en la implementación de tecnologías emergentes para la medicina individualizada y predictiva. MASK (MACVIA [Contre les Maladies Chroniques pour un Vieillissement Actif] Aria Sentinel Network) utiliza la tecnología móvil para desarrollar vías de atención que permitan el manejo de la rinitis y del asma por un grupo multidisciplinario o por los propios pacientes. Una aplicación (app) para iOS y Android está disponible en 20 países y 15 idiomas; utiliza una escala analógica visual para evaluar el control de los síntomas y la productividad del trabajo, así como un sistema de apoyo para las decisiones clínicas. Se asocia con una tabla interoperable (que permite intercambiar información) para médicos y otros profesionales de la salud. La estrategia de escalamiento utiliza las recomendaciones de la Asociación Europea de Innovación para el Envejecimiento Activo y Saludable. El objetivo del nuevo enfoque ARIA es proporcionar una vida activa y saludable a las personas afectadas por la rinitis, cualquiera que sea su edad, sexo o condición socioeconómica, con el fin de reducir las desigualdades sociales y de salud causadas por la enfermedad.

Efficacy and safety of tiotropium in school-age children with moderate-to-severe symptomatic asthma: A systematic review.

BACKGROUND: Recently published data support the benefits and safety of the once-daily (OD) long-acting anticholinergic tiotropium bromide bronchodilator for the treatment of uncontrolled moderate-to-severe asthma in adults and adolescents. However, its role for the treatment of school-age asthmatics has not yet been clearly defined. The aim of this systematic review was to assess the efficacy and safety of tiotropium Respimat® in children aged 6-11 years with moderate-to-severe symptomatic asthma. METHODS: Randomized, placebo-controlled trials were included. Primary outcomes were peak forced expiratory volume in 1 s measured within 3 h post-dosing) [FEV1 (0-3 h) ] and trough FEV1 measured at the end of the dosing interval. RESULTS: Three studies (more than 900 patients) were selected. Tiotropium was associated with significant improvements in FEV1 peak (mean change from baseline) by 102 mL (P<.0001) and trough by 82 mL (P<.0001) compared with placebo. Tiotropium 5 µg dose presented a trend (statistically non-significant) toward a greater bronchodilation in comparison with 2.5 µg dose. Tiotropium significantly increased the rate of the Asthma Control Questionnaire (ACQ-7) responders compared with placebo (82.2% vs 75.4%, number needed to treat for benefit [NNTB]=15) and significantly decreased the number of patients with at least one exacerbation in comparison with placebo (29.1% vs. 39.8%, with a NNTB of 10). There were no significant differences in rescue medication use, withdrawals, and adverse events. CONCLUSIONS: OD tiotropium Respimat® is efficacious and well tolerated as an add-on to inhaled corticosteroids plus one or more controller medications in school-age symptomatic asthmatics.

A systematic review with meta-analysis of fluticasone furoate/vilanterol combination for the treatment of stable COPD.

BACKGROUND: Current guidelines recommend the use of inhaled corticosteroids/long-acting beta2-agonists as first-line therapy for COPD patients at risk for acute exacerbations and/or severe airflow limitation. This systematic review assesses available evidence on the efficacy and safety of fluticasone furoate/vilanterol (FF/VI) combination versus each alone, for the treatment of patients with severe to very severe stable COPD. METHODS: Randomized, placebo-controlled trials of >8 weeks of duration were included. Primary end points were pulmonary function, COPD exacerbations and serious adverse events. FF/VI was compared with its mono-components. RESULTS: Five reports with six trials (n = 15,515 patients) met the entry criteria. FF/VI was associated with significant increases in trough FEV1 compared with vilanterol (VI) and fluticasone furoate (FF) (45 mL and 90 mL respectively). FF/VI significantly reduced the number of subjects with at least one moderate to severe exacerbation compared with VI (number needed to treat for benefit [NNTB] = 21) and with FF (NNTB = 26). There were no statistical differences in the rates of serious adverse events, cardiac events and all-cause mortality. On the contrary, FF/VI showed a significant 52% increase in the rate of pneumonia compared with VI monotherapy (5.3% vs. 3.5%). However, there was no difference in the rate of pneumonia when FF/VI was compared with FF alone. CONCLUSIONS: FF/VI combination was associated with a decrease of the rate of COPD exacerbations, without affecting mortality or cardiovascular outcomes in patients with moderate to severe stable COPD. Also, the use of FF was associated with an increased risk of pneumonia.

Asthma-chronic obstructive pulmonary disease overlap syndrome: a controversial concept.

PURPOSE OF REVIEW: To illustrate the scant evidence and the shortcomings of the concept of 'asthma-COPD overlap syndrome' (ACOS) in terms of clinical utility. RECENT FINDINGS: Asthma and chronic obstructive pulmonary disease (COPD) are considered as two distinct and heterogeneous diseases. For many years, physicians have been aware that asthma and COPD can coexist in some patients. Recently, the term ACOS has been applied when a person has clinical features of both asthma and COPD. However, the lack of an accurate diagnosis has led to inconsistent data regarding reported prevalence, prognosis and therapeutics. Even today, it has not been possible to establish a phenotypic characterization of ACOS, although it is part of the overall complexity and heterogeneity of COPDs. No high quality data exist on which to base treatment recommendations for ACOS. Consequently, in clinical practice, treatment is extrapolated from the available evidence on asthma and COPD. SUMMARY: The current concept of ACOS seems clinically irrelevant because it has no influence on the prognosis and treatment of these patients. The authors concluded that the term ACOS should be avoided in the case of patients with features of both asthma and COPD.

Allergen immunotherapy on the way to product-based evaluation-a WAO statement.

Allergen immunotherapy (AIT) is widely used in clinical practice for patients with moderate to severe allergic rhinitis due to inhalant allergens and may be delivered via subcutaneous (SCIT) and sublingual routes (SLIT). However, the quality of evidence for individual AIT products is very heterogeneous, and extensions of overall conclusions ("class effects") on the efficacy and disease-modifying effects to all AIT products are unjustified. In contrast, each product needs to be evaluated individually, based on available study results, to justify efficacy and specific claims on sustained and disease modifying effects per allergen and targeted patient group (children vs. adults, allergic rhinitis vs. asthma). WAO intends to support the current development to evidence-based AIT, which ultimately will lead to a more efficacious treatment of allergic patients and the appropriate recognition of AIT.

Assessment of acute asthma severity in the ED: are heart and respiratory rates relevant?

BACKGROUND: Assessment of acute asthma severity in the emergency department (ED) determines the appropriate initial therapy. The aim of this study was to evaluate the usefulness of heart and respiratory rates as determinants of severity of asthma exacerbations. METHODS: It was a pooled analysis of individual patient data from different controlled clinical trials performed over a 9-year period. The sample was characterized by patients with a diagnosis of asthma, age 18 to 50 years, and a forced expiratory volume in the first second (FEV1) or a peak expiratory flow less than or equal to 50% of predicted at ED presentation. RESULTS: One thousand one hundred ninety-two severe acute asthmatics (age 33.9 ± 10.3 years and FEV1 = 27.4% ± 9.7%) were enrolled. Two-thirds of patients were categorized as having severe acute asthma (FEV1, 31%-50% of predicted) and the remaining third as life-threatening asthma (FEV1, ≤30% of predicted). There were no relationships between the intensity of airway obstruction as measured by the FEV1 and the degree of tachycardia (r = 0.05, P > .1) or tachypnea (r = 0.06, P > .1). Only 22% and 19% of the patients, respectively, met the heart rate and respiratory rate requirements for acute severe asthma (≥120/min and ≥25/min, respectively). In contrast to FEV1 and arterial oxygen saturation, baseline heart and respiratory rates did not predict admissions of patients at the end of treatment. CONCLUSIONS: This pooled analysis suggests a poor performance of heart and respiratory rates as determinants of acute asthma severity in the ED.

Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents.

BACKGROUND: There are less data on omalizumab treatment in pediatric asthma than in adult population. Thus, to establish the efficacy and safety of subcutaneous omalizumab as an add-on therapy, a systematic review of placebo-controlled studies was performed. METHODS: Primary outcome was the frequency of asthma exacerbations. Secondary outcomes included spirometric measures, rescue medication use, asthma symptoms, health-related quality of life, and adverse events. RESULTS: Three randomized controlled trials (1381 participants) fulfilled the selection criteria. During the stable phase, omalizumab decreased the number of patients with at least one significant asthma exacerbation (26.7% vs. 40.6%, NNTB = 7, 95% CI, 5, 11). The predefined post hoc subgroup analysis showed that duration of treatment did not influence this result. During the steroid reduction phase, omalizumab reduced the number of patients with at least one exacerbation (RR = 0.48, 95% CI, 0.38, 0.61; NNTB = 6, 95% CI, 4, 8) and also the mean number of asthma exacerbations per patient (MD = -0.44, 95% CI, -0.72, -0.17) when compared to placebo. The frequency of serious adverse events was similar between omalizumab (5.2%) and placebo (5.6%), and there were no evidence of increased risk of hypersensitivity reactions, nor malignant neoplasms. CONCLUSIONS: Data indicate that the efficacy of an add-on omalizumab in patients with moderate-to-severe allergic asthma uncontrolled with recommended inhaled steroid treatment is accompanied by an acceptable safety profile.