Characteristics of Users and New Initiators of Single- and Multiple-Inhaler Triple Therapy for Chronic Obstructive Pulmonary Disease in Germany.

Purpose: To assess patient characteristics of users and new initiators of triple therapy for chronic obstructive pulmonary disease (COPD) in Germany. Patients and Methods: Retrospective cohort study of patients with COPD and ≥1 prescription for single-inhaler triple therapy (SITT; fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI] or beclomethasone dipropionate/glycopyrronium bromide/formoterol [BDP/GLY/FOR]) or multiple-inhaler triple therapy (MITT), using data from the AOK PLUS German sickness fund (1 January 2015-31 December 2019). The index date was the first date of prescription for FF/UMEC/VI or BDP/GLY/FOR (SITT users), or the first date of overlap of inhaled corticosteroid, long-acting ß2-agonist, and long-acting muscarinic antagonist (MITT users). Two cohorts were defined: the prevalent cohort included all identified triple therapy users; the incident cohort included patients newly initiating triple therapy for the first time (no prior use of MITT or SITT in the last 2 years). Patient characteristics and treatment patterns were assessed on the index date and during the 24-month pre-index period. Results: In total, 18,630 patients were identified as prevalent triple therapy users (MITT: 17,945; FF/UMEC/VI: 700; BDP/GLY/FOR: 908; non-mutually exclusive) and 2932 patients were identified as incident triple therapy initiators (MITT: 2246; FF/UMEC/VI: 311; BDP/GLY/FOR: 395; non-mutually exclusive). For both the prevalent and incident cohorts, more than two-thirds of patients experienced ≥1 moderate/severe exacerbation in the preceding 24 months; in both cohorts more BDP/GLY/FOR users experienced ≥1 moderate/severe exacerbation, compared with FF/UMEC/VI and MITT users. Overall, 97.9% of prevalent triple therapy users and 86.4% of incident triple therapy initiators received maintenance treatment in the 24-month pre-index period. Conclusion: In a real-world setting in Germany, triple therapy was most frequently used after maintenance therapy in patients with recent exacerbations, in line with current treatment recommendations.

Triple therapy (a combination of three different respiratory inhaled medications) is recommended for patients with chronic obstructive pulmonary disease (COPD) who experience repeated short-term symptom flare-ups when taking dual therapy (a combination of two different respiratory medications). Previously, patients had to take triple therapy using two or three separate inhalers. More recently, single-inhaler triple therapies have been developed, meaning patients can take all three different medications at the same time via one single inhaler. This study assessed the characteristics of patients who were already receiving triple therapy, or who started triple therapy (either via multiple inhalers or a single inhaler), in Germany between January 2015 and December 2019. In total, 18,630 patients who were already receiving triple therapy during the study period, and 2932 patients who newly started using triple therapy were included. The study reported that more than two-thirds of included patients had experienced at least one flare-up of COPD symptoms in the 2 years before starting triple therapy. Most patients had also received another therapy for COPD before starting triple therapy. A small proportion of patients started taking triple therapy after receiving no other therapy for COPD in the previous 2 years. The results of the study suggest that triple therapy for COPD in Germany is most often used in accordance with recommendations (patients already receiving therapy and experiencing repeated symptom flare-ups).

Differential Response to 12 Weeks of Once-Daily Tiotropium/Olodaterol Fixed Dose Combination in Patients with COPD: A Multidimensional Response Profiling in the TORRACTO Study.

Purpose: Long-acting bronchodilators (LABD), in general, reduce respiratory symptoms, improve exercise endurance time and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). However, there might be heterogeneity in improvement for several outcomes on an individual level. Therefore, we aimed to profile the multidimensional response in patients receiving tiotropium/olodaterol (T/O) using self-organizing maps (SOM). Materials and Methods: This is a secondary analysis of the TORRACTO study: a multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effects of T/O (2.5/5 and 5/5 µg) compared with placebo after 6 and 12 weeks of treatment in patients with COPD. In the current study, we used endurance time, forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), inspiratory capacity (IC) at rest and IC at isotime (ICiso) to identify clusters by means of SOM in patients treated with T/O. Results: Six clusters with distinct response profiles were generated at week 12 in COPD patients receiving T/O (n = 268). Patients in cluster 1 improved significantly on all outcomes, whilst cluster 5 showed strong improvement in endurance time (357s); contrarily, FEV1, FVC, ICrest and ICiso decreased when compared to baseline. Conclusion: Individual responses on endurance time and pulmonary function after 12 weeks of T/O are heterogeneous. This study identified clusters in COPD patients with markedly different multidimensional response on LABD.

Dynamic Analysis of Aerosol Release from a Pressurized Metered Dose Inhaler Combined with a Valved Holding Chamber Using Simplified Laser Photometry.

Background: A pressurized metered dose inhaler combined with a valved holding chamber (pMDI+VHC) is used to prevent upper airway complications and improve the efficiency of inhaled drug delivery; however, the aerodynamic behavior of the released particles has not been well investigated. This study aimed at clarifying the particle release profiles of a VHC using simplified laser photometry. Methods: An inhalation simulator comprised a computer-controlled pump and a valve system that withdrew aerosol from a pMDI+VHC using a jump-up flow profile. A red laser illuminated the particles leaving VHC and evaluated the intensity of the light reflected by the released particles. Results: The data suggested that the output (OPT) from the laser reflection system represented particle concentration rather than particle mass, and the latter was calculated as OPT × instantaneous withdrawn flow (WF). Summation of OPT hyperbolically decreased with flow increment, whereas summation of OPT × instantaneous flow was not influenced by WF strength. Particle release trajectories consisted of three phases, namely increment with a parabolic curve, flat, and decrement with exponential decay phases. The flat phase appeared exclusively at low-flow withdrawal. These particle release profiles suggest the importance of early phase inhalation. The hyperbolic relationship between WF and particle release time revealed the minimal required withdrawal time at an individual withdrawal strength. Conclusions: The particle release mass was calculated as laser photometric output × instantaneous flow. Simulation of the released particles suggested the importance of early phase inhalation and predicted the minimally required withdrawal time from a pMDI+VHC.

As-needed inhaled corticosteroids as add-on therapy versus SMART therapy: an evolving understanding of the two approaches in the management of moderate-to-severe asthma.

PURPOSE OF REVIEW: Asthma is the most common chronic respiratory disorder, characterized by recurring, reversible airflow obstruction due to inflammation and airway hyperresponsiveness. Although biologics have provided significant advances in the treatment of asthma, they are expensive, and their use remains restricted to more severe asthma. Additional approaches in the management of moderate-to-severe asthma are necessary. RECENT FINDINGS: ICS-formoterol as maintenance and reliever therapy in asthma and its effect on improved asthma control has been demonstrated in multiple cohorts of asthma. Although ICS-formoterol as maintenance and reliever therapy has been widely validated, there are significant design considerations including the requirement for exacerbation and bronchodilator response and the lack of evidence for effectiveness in patients who use nebulized reliever therapies, which may limit the use of this therapy in selected populations. More recent trials of as-needed ICS have demonstrated effectiveness in reducing asthma exacerbations and improvements in asthma control and may provide an additional therapeutic strategy for individuals with moderate-to-severe asthma. SUMMARY: Both ICS-formoterol as a maintenance and a reliever as well as as-needed ICS have demonstrated significant improvements in the control of moderate-to-severe asthma. Future investigational work will be necessary to elucidate whether a strategy of ICS-formoterol as maintenance and reliever therapy or an as-needed ICS strategy demonstrates superiority in asthma control in the context of the cost to individual patients and health systems.

The Buddhasothorn Asthma Severity Score (BASS): A practical screening tool for predicting severe asthma exacerbations for pediatric patients

Background and aim: A precise scaling system of acute asthma leads to an accurate assessment of disease severity. This study aimed to compare the accuracy of the Buddhasothorn Asthma Severity Score (BASS) with the Wood–Downes–Ferrés Scale (WDFS) to recognize the severity level of acute asthma. Materials and methods: A cross-sectional study was conducted comprising Thai children aged 2–15 years with acute asthma. The BASS and WFDS were rated once in the emergency department. The degree of severity was determined by frequency and type of nebulized bronchodilator administrations at the time of initial treatment. The optimum cutoff points for the area under the curve (AUC) were established to predict severe asthma exacerbations. Results: All 73 episodes of asthma exacerbations (EAEs) in 35 participants were analyzed. Fifty-nine (80.8%) EAEs were classified as severe. Both scales had good significance to recognize the selection of nebulized bronchodilator treatments by AUC of 0.815 (95% Confidence Interval [CI]: 0.680–0.950) in case of BASS, and AUC of 0.822 (95% CI: 0.70–0.944) in case of WDFS. Cutoff points of BASS ≥ 8 had sensitivity 72.9%, specificity 64.3%, positive predictive value (PPV) 89.6%, negative predictive value (NPV) 36.0% at an AUC of 0.718 (95% CI: 0.563–0.873) for severe exacerbations. These results were consistent for cutoff points of WDFS ≥ 5 with sensitivity 78.0%, specificity 50.0%, PPV 86.8%, NPV 35.0% at an AUC of 0.768 (95% CI: 0.650–0.886) for predicting severe exacerbations. There was no significant difference between the AUCs of both scales. Conclusions: Both the BASS and WDFS were good and accurate scales and effective screening tools for predicting severe asthma exacerbations in pediatric patients by optimal cutoff points (AU)

Assessment and management of asthma exacerbations in an emergency department unit

Background: The Pediatric Respiratory Assessment Measure (PRAM) score is a useful tool for the assessment of asthma exacerbations in children. This study aimed to estimate the risk of hospitalization in children, assessed with the PRAM score and having mild–moderate asthma exacerbation, who were treated with salbutamol delivered via a metered-dose inhaler and spacer (MDI/S). Methods: The study population consisted of children aged 3–16 years with mild–moderate asthma exacerbations. All children received 1mg/kg prednisolone p.o. (max 40 mg) and 4–6 puffs of salbutamol via MDI/S. Results: Fifty patients participated in the study. Admission was associated positively with the initial PRAM score (OR: 18.91, CI: 2.42–123.12, P = 0.005) and negatively with the improvement in PRAM score (OR: 0.52, CI: 0.01–0.78, P = 0.032). Conclusion: PRAM is a reliable tool that can be used effectively to estimate the asthma exacerbation severity (AU)

A narrative review on the Synchrobreathe™: A novel breath-actuated pressurised metered-dose inhaler for the treatment of obstructive airway diseases.

Pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), are widely used to deliver drugs for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Incorrect use of inhalers is one of the main obstacles to achieving better clinical control. Indeed, with pMDIs, patients fail to synchronise actuation with inhalation due to a lack of coordination and with DPIs insufficient inspiratory effort compromises drug deposition in lungs. More than 50% of patients desire to switch their pMDIs and DPIs for a better device. This led to the development of pressurised breath-actuated inhalers (BAIs) with the aim of combining the beneficial features of pMDIs and DPIs and mitigating their problems. BAIs, e.g., Synchrobreathe™, are designed such that they are activated by a low inhalation effort and mechanically actuate the dose in synchrony to inspiration, thereby resolving the need to coordinate actuation with inspiration. BAIs have advantages, including ease of use, high lung deposition of medication, and greater patient preference. We discussed the design features, operating procedure, and clinical evidence of the Synchrobreathe™ device (Cipla Ltd, India), a BAI available with a wide range of drug combinations. Studies have shown that a higher number of patients (68.19%) used the Synchrobreathe™ without any error than the pMDI (56.21%), and that the vast majority of them (92%) found it easy to understand and use. The Synchrobreathe™ is an innovative, easy-to-use inhaler that may overcome many limitations associated with pMDIs and DPIs, thus potentially improving management of obstructive airway diseases and patients' quality of life.

Consultas a urgencia y valores espirométricos tras el reemplazo de salmeterol/fluticasona por budesonida/formoterol en pacientes con asma moderada a grave / Emergency consultations and spirometric values after replacement of salmeterol/fluticasone with budesonide/formoterol in patients with moderate to severe asthma

El asma se caracteriza por su impacto deletéreo que incluye gran coste económico para el sistema de salud. En pacientes con asma mal controlada a pesar del tratamiento, se propone un régimen de mantenimiento con corticoides inhalados y formoterol. El objetivo del presente estudio observacional retrospectivo fue evaluar las modificaciones espirométricas tras el cambio del medicamento controlador en pacientes con asma moderada a severa asistidos en el Hospital Clínico de Magallanes de Punta Arenas, así como también cuantificar la modificación en el número de exacerbaciones graves (consulta a un servicio de urgencia y/u hospitalización por asma). Participaron 61 adultos con asma moderada a severa (mediana de edad: 60 años [rango: 21-87], mujeres: 69,4%; comorbilidad atópica/alérgica: 79%; otras comorbilidades: 46,8%) en los que se cambió el tratamiento con fluticasona/salmeterol 250/25 μg por budesónida/formoterol 160/4,5 μg. No se observaron cambios significativos en los índices espirométricos tras el cambio. Con el tratamiento inicial, el 46,9% presentó ≥ 1 visita a urgencias (total: 50 consultas). Tras el cambio por budesonida/formoterol, el 21% requirió al menos una visita a urgencias (total: 14 consultas; p < 0,01). La proporción de pacientes con ≥ 2 consultas a urgencias fue de 19,7% con el tratamiento basal y de 1,6% tras el cambio a budesonida/formoterol (p < 0,01). No se observaron diferencias significativas en la cantidad de hospitalizaciones. En este estudio del mundo real de pacientes con asma moderada a grave, el cambio del tratamiento a budesonida/formoterol se asoció con reducción significativa de las consultas a urgencias, a pesar de no detectarse cambios de significación estadística en los índices espirométricos habituales.

Asthma is characterized by its deleterious impact, including a high cost to the healthcare system. In patients with poorly controlled asthma despite treatment, a maintenance regimen of inhaled corticosteroids and formoterol is proposed. The aim of this retrospective, observational study was to evaluate the spirometric changes after switching the controller medication in patients with moderate to severe asthma attended in our institution ("Hospital Clínico de Magallanes"), as well as the variation in the number of severe exacerbations (consultation to an emergency department and/or hospitalization for asthma). Sixty-one adults with moderate to severe asthma (median age: 60 years-old [range: 21-87], women: 69.4%; atopic/allergic comorbidity: 79%; other comorbidities: 46.8%) in whom treatment with fluticasone/salmeterol 250/25 μg was switched to budesonide/formoterol 160/4.5 μg participated in our study. No significant changes in spirometric parameters were observed after the replacement treatment. With the initial treatment, 46.9% patients presented ≥ 1 visit to the emergency department (total: 50 visits). After the switch to budesonide/formoterol, 21% required at least one emergency department visit (total: 14 consultations; p < 0.01). The proportion of patients with ≥ 2 emergency department visits was 19.7% with baseline treatment and 1.6% after switching to budesonide/formoterol (p < 0.01). No significant differences were observed in the number of hospitalizations. In this real-world study of moderate to severe asthma patients, switching to budesonide/formoterol was associated with a significant reduction in emergency department visits, despite no statistically significant changes in the usual spirometric parameters.

Effect of budesonide formoterol combined with tiotropium bromide on pulmonary function and inflammatory factors in patients with asthma–COPD overlap syndrome

Objective: To investigate the clinical efficacy of combining budesonide formoterol with tiotropium bromide for treating asthma–chronic obstructive pulmonary disease overlap syndrome (AOCS). Methods: The data of 104 patients with AOCS admitted to our hospital from December 2019 to December 2020 were assessed, randomly and divided into an experimental group (comprising 52 patients, receiving drug combination therapy) and a conventional group (comprising 52 patients, receiving drug therapy alone). Patients’ clinical efficacy, pulmonary function, fractioned exhaled nitric oxide (FeNO), immune function, endothelial function, serum lipid peroxidation injury indexes, adverse reactions, and quality of life scores were compared. Results: Prior to treatment, no significant differences were observed in various pulmonary function indicators, FeNO, immune function, endothelial function, and lipid peroxidation injury indexes between the two groups (P > 0.05). However, after treatment, all observation indexes in both groups improved to different levels, with the experimental group -demonstrating -significantly superior improvement, compared to the conventional group (P < 0.05). We also observed that adverse reactions in the experimental group were significantly lower than in the conventional group (P < 0.05). Conclusion: The combination of budesonide formoterol to tiotropium bromide in treating asthma–COPD overlap syndrome may significantly improve pulmonary function, endothelial function, and immune status of patients and encourage the recovery of serum lipid peroxidation injury; therefore, this may deserve widespread adoption and application (AU)

Effect of budesonide combined with montelukast sodium on pulmonary function parameters and immunoglobulin levels in children with bronchial asthma

Background and aim: Bronchial asthma is a prevalent type of respiratory disease that affects a large proportion of pediatric patients. The purpose of this study is to further investigate the clinical effects of budesonide combined with montelukast sodium in treating bronchial asthma. Methods: Eighty-six children with bronchial asthma were equally divided into study and control groups via randomized double-blind controlled trial. The control group was treated with aerosol inhalation of budesonide combined with placebo, while the study group was treated with budesonide combined with montelukast sodium. Pulmonary function parameters, immunoglobulin, and recovery of related symptoms, along with the adverse reaction rate, were observed and compared between both groups. Results: Before treatment, there was no marked difference in pulmonary function parameters and immunoglobulin indexes between both groups (P > 0.05). All pulmonary function indicators and immunoglobulin indexes in both groups improved following therapy, with the study group outperforming the control group (P < 0.05). The recovery time of related symptoms in the study group was shorter than that in the control group (P < 0.05). The incidence of adverse reactions in both groups was compared, with notable differences (P < 0.05). Conclusion: Budesonide combined with montelukast sodium in the treatment of bronchial asthma has the value of clinical application and promotion (AU)

Effects of omalizumab combined with budesonide formoterol on clinical efficacy, pulmonary function, immune function, and adverse reactions in children with moderate and severe allergic asthma

Objective: To evaluate the clinical efficacy and safety of combining omalizumab with budesonide formoterol to treat children with moderate and severe allergic asthma, and investigate the effect of this combination therapy on pulmonary and immune functions. Methods: The data of 88 children with moderate and severe allergic asthma, who were admitted to our hospital between July 2021 and July 2022, were included in the study. The patients were randomly assigned either to control group (n = 44; received budesonide formoterol inhalation therapy) or experimental group (n = 44; received omalizumab subcutaneous injection + budesonide formoterol inhalation therapy) using computer-generated randomization. The clinical efficacy, asthma control (measured using childhood Asthma-Control Test [C-ACT] score), pulmonary function (forced expiratory volume in 1 s, forced vital capacity, and peak expiratory flow), immune function (cluster of differentiation 3 cells [CD3+ cells], cluster of differentiation 4 cells [CD4+ cells], immunoglobulin G, immunoglobulin A, and immunoglobulin E), and adverse reactions were observed and compared between both groups. Results: After treatment, the experimental group had improved levels of pulmonary function and immune function indexes, higher C-ACT scores, and a higher overall response rate than the control group (P < 0.05). In addition, the incidence of adverse reactions was not significantly different between both groups (P > 0.05). Conclusion: The combination of omalizumab with budesonide formoterol for treating moderate and severe allergic asthma in children demonstrated promising clinical efficacy and improved their pulmonary and immune functions, leading to more rational asthma control. The combined regimen demonstrated satisfactory clinical safety and deserved clinical promotion (AU)

Riesgos, fenotipos y comparación de tratamiento de EPOC en atención primaria según guías GOLD y GesEPOC / Risks, phenotypes and comparison between treatments according to guidelines GOLD and GesEPOC in primary care

Introducción La enfermedad pulmonar obstructiva crónica (EPOC) es una patología infradiagnosticada, con una elevada morbimortalidad. El diagnóstico y el seguimiento se realizan en gran parte en atención primaria (AP). El objetivo de nuestro estudio es clasificar los pacientes EPOC de acuerdo con GOLD 2019 y GesEPOC 2017. Como objetivos secundarios, analizar el tipo de riesgo, describir y comparar el tratamiento pautado con el recomendado por las guías. Material y métodos Estudio observacional transversal multicéntrico realizado en siete equipos de AP. Se incluyeron 637 pacientes EPOC entre 35 y 85años. Resultado La edad media fue de 70,3años, el 84,6% tenían comorbilidades y el 43,5% eran fumadores activos. El FEV1 post-broncodilatador medio fue del 61,92% (DE: 17,42). Predominaron los pacientes con mMRC=1 (43,8%), 57,8% CAT<10. Índice BODEx leve (75,7%). GoldA fue mayoritario (47,7%). El fenotipo más frecuente fue el no agudizador (61,1%). El 25% fueron ACO. El 56,2% eran pacientes de bajo riesgo. El 20,6% no tenían prescrito ningún tratamiento, LABA +LAMA +CI (19,6%), LAMA +LABA (16,5%) y LAMA (16,3%). Si comparamos los tratamientos que tienen pautados los pacientes con lo que recomienda la GOLD, obtenemos que el 61% coinciden con una concordancia moderada, mientras que si los comparamos con la GesEPOC, el 53,8% coinciden con concordancia débil. El 73,4% de los tratamientos coinciden entre ambos documentos (concordancia moderada). Conclusiones Los pacientes EPOC atendidos en AP son de bajo riesgo, leves y no agudizadores. Si comparamos los tratamientos que tienen pautados los pacientes con lo que recomiendan la GOLD y la GesEPOC, encontramos una concordancia moderada y débil, respectivamente (AU)

Introduction Chronic obstructive pulmonary disease (COPD) is an underdiagnosed pathology with a high morbidity and mortality. Diagnosis and follow-up are mostly carried out in primary care (PC). The objective of our study is to classify COPD patients according to GOLD 2019 and GesEPOC 2017 guidelines. As secondary objectives, to analyze the type of risk and to describe and compare the prescribed treatment with that recommended by the guidelines. Material and methods Multicenter cross-sectional observational study in seven Health Care centers. 637 COPD patients between 35 and 85years old were included. Results The mean age was 70.3years old, 84.6% had comorbidities and 43.5% were active smokers. The mean post-bronchodilator FEV1 was 61.92% (SD: 17.42). Most are patients with mMRC=1 (43.8%), 57.8% CAT<10. Mild BODEx index (75.7%). GoldA was the majority (47.7%). The most frequent phenotype was non-exacerbator (61.1%). 25% were ACOs. 56.2% were low-risk patients. 20.6% had not been prescribed any treatment, LABA +LAMA +CI (19.6%), LAMA +LABA (16.5%) and LAMA (16.3%). If we compare the treatments that the patients have prescribed, with the one is recommended by GOLD, we obtain that 61% coincide with moderate concordance, while if we compare with GesEPOC, 53.8% coincide with weak concordance. 73.4% of the treatments coincide between both documents (moderate agreement). Conclusions COPD patients treated in PC are low risk, mild and non-exacerbators. If we compare the treatments that the patients have prescribed, with what is recommended by GOLD and GesEPOC, we find a moderate and weak concordance, respectively (AU)

Adherence and quality of life assessment in patients with asthma treatment with budesonide/formoterol via the Elpenhaler device: the COMPLETE study.

BACKGROUND: Asthma is a chronic inflammatory disease of the airways that causes recurring episodes of wheezing, breathlessness, chest tightness and coughing. Inhaled drugs on a daily basis are the cornerstone of asthma treatment, therefore, patient adherence is very important. METHODS: We performed a multicenter, open, non-interventional, observational, prospective study of 716 adult patients diagnosed with asthma receiving FDC (Fixed-dose combination) budesonide/formoterol via the Elpenhaler device. We assessed the adherence to treatment at 3 and 6 months (based on the MMAS-8: 8-item Morisky Medication Adherence Scale), the quality of life and change in forced expiratory volume in 1 s (FEV1) from baseline to follow-up. RESULTS: Approximately 80% of the patients showed medium to high adherence throughout the study. The mean (SD) MMAS-8 score at 6 months was 6.85 (1.54) and we observed a statistically significant shift of patients from the low adherence group to the high adherence group at 6 months. Moreover, after 6 months of treatment with FDC budesonide/formoterol, we observed an increase in the patients' quality of life that as expressed by a change 2.01 (95%CI 1.93-2.10) units in Mini AQLQ (p < 0.0001) that was more pronounced in the high adherence group. The same trend was also observed in terms of spirometry (mean FEV1 2.58 L (0.85) at the end of the study, increased by 220 mL from baseline) with a higher improvement in the medium and high adherence groups. CONCLUSIONS: Treatment with FDC of budesonide/formoterol via the Elpenhaler device was associated with improvement in asthma-related quality of life and lung function over 6 months that were more prominent in patients with higher adherence. TRIAL REGISTRATION: 2017-HAL-EL-74 (ClinicalTrials.gov Identifier: NCT03300076).

Revisión narrativa de la terapia inhalatoria en la EPOC / COPD inhaled therapy narrative review

La terapia inhalada con broncodilatadores de acción larga es la base del tratamiento farmacológico de la EPOC. Con el fin conocer los que ofrecen un mejor control, se realizó una búsqueda en Medline (Pubmed). Se analizaron los estudios comparativos de terapia inhaladora en pacientes con EPOC. Tras la comparación entre la combinación fija LABA/LAMA frente LABA/CI en pacientes no exacerbadores, se concluye que hay un mejor control con LABA/LAMA. Dentro de las combinaciones LABA/CI, la combinación budesonida/formoterol ofreció un mejor control. En la terapia LAMA no hay grandes diferencias, pero comparada con LABA ofreció un mayor control. La triple terapia en un único dispositivo se muestra superior a la doble terapia y a la triple terapia en dos dispositivos, no habiendo diferencias relevantes entre las combinaciones disponibles (AU)

Inhaled therapy with long-acting bronchodilators is the base of pharmacological treatment in COPD. In order to find out those that offer better control, a search was carried out in Medline (Pubmed). Comparative studies of inhaler therapy in COPD patients were analyzed. The comparison between the fixed combination LABA/LAMA versus LABA/CI in non-exacerbating patients, revealed a better control with LABA/LAMA. Within the LABA/CI combinations, budesonide/formoterol combination offered better control. LAMA inhalers revealed no great differences, but when compared to LABA, it offered a better control. Regarding triple therapy in a single device, was superior to double therapy and to triple therapy in two devices, with no relevant differences among the available combinations(AU)

Humidified and standard oxygen therapy in acute severe asthma in children (HUMOX): A pilot randomised controlled trial.

BACKGROUND: Oxygen (O2) is a mainstay of treatment in acute severe asthma but how it is administered varies widely. The objectives were to examine whether a trial comparing humidified O2 to standard O2 in children is feasible, and specifically to obtain data on recruitment, tolerability and outcome measure stability. METHODS: Heated humidified, cold humidified and standard O2 treatments were compared for children (2-16 years) with acute severe asthma in a multi-centre, open, parallel, pilot randomised controlled trial (RCT). Multiple outcomes were assessed. RESULTS: Of 258 children screened, 66 were randomised (heated humidified O2 n = 25; cold humidified O2 n = 21; standard O2 n = 20). Median (IQR) length of stay (hours) in hospital was 37.9 (29.1), 52 (35.4) and 49.1 (29.7) for standard, heated humidified and cold humidified respectively and time (hours) on O2 was 15.9 (9.4), 13.6 (14.9) and 13.1 (14.9) for the three groups respectively. The mean (standard deviation) time (hours) taken to step down nebulised to inhaled treatment was 5.6 (14.3), 35.1 (28.2) and 32.7 (20.1). Asthma Severity Score decreased in all three groups similarly, although missing data prevented complete analysis. Humidified O2 was least well tolerated with eight participants discontinuing their randomised treatment early. An important barrier to recruitment was research nurse availability. CONCLUSION: Although, the results of this pilot study should not be extrapolated beyond the study sample and inferential conclusions should not be drawn from the results, this is the first RCT to compare humidified and standard O2 therapy in acute severe asthmatics of any age. These findings and accompanying screening data show that a large RCT of O2 therapy is feasible. However, challenges associated with randomisation and data collection should be addressed in any future trial design.

The relationship between peak inspiratory flow and hand grip strength measurement in men with mild chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) decreases quality of life and muscular strength. Inspiratory flow is important for inhalants in the bronchi but is complicated to measure in routine practice. We hypothesized that hand grip strength (HGS) would correlate with inhalation rate in patients with mild COPD. METHODS: The COPD patients were recruited at the St. Marianna University School of Medicine, Yokohama Seibu Hospital, from 2015 to 2018. We measured peak inspiratory flow (PIF) through an In-Check flow meter attached with Diskus [PIF(D)] and Turbuhaler [PIF(T)] inhalers. The 6-min walking test (6MWT), and the fraction of exhaled nitric oxide (FENO), spirometry, HGS, or forced oscillation technique (FOT) parameters were measured. RESULTS: Forty-four subjects were enrolled. All were men, with a mean age (± SD) of 77.8 ± 9.36 years. Thirty-nine patients had mild COPD. PIF(D) was 110 (80, 140) L/min (median, interquartile range), PIF(T) was 80 (70, 90) L/min, and HGS was 28.7 (13.8, 43.6) kgf. PIF(D) and PIF(T) were significantly correlated (r = 0.443, p = 0.003). PIF(D) was significantly correlated with age (r = - 0.327, p = 0.030) and HGS (r = 0.326, p = 0.031). PIF(T) was significantly correlated with age (r = - 0.328, p = 0.030), FVC (r = 0.351, p = 0.019), 6MWT distance (r = 0.392, p = 0.011), and HGS (r = 0.328, p = 0.030). CONCLUSION: HGS might be more useful for predicting PIF than other parameters. Also, elderly COPD patients need to be taught inhaled methods carefully.

Effects of azithromycin on bronchial remodeling in the natural model of severe neutrophilic asthma in horses.

Steroid resistance in asthma has been associated with neutrophilic inflammation and severe manifestations of the disease. Macrolide add-on therapy can improve the quality of life and the exacerbation rate in refractory cases, possibly with greater effectiveness in neutrophilic phenotypes. The mechanisms leading to these beneficial effects are incompletely understood and whether macrolides potentiate the modulation of bronchial remodeling induced by inhaled corticosteroids (ICS) is unknown. The objective of this study was to determine if adding azithromycin to ICS leads to further improvement of lung function, airway inflammation and bronchial remodeling in severe asthma. The combination of azithromycin (10 mg/kg q48h PO) and inhaled fluticasone (2500 µg q12h) was compared to the sole administration of fluticasone for five months in a randomized blind trial where the lung function, airway inflammation and bronchial remodeling (histomorphometry of central and peripheral airways and endobronchial ultrasound) of horses with severe neutrophilic asthma were assessed. Although the proportional reduction of airway neutrophilia was significantly larger in the group receiving azithromycin, the lung function and the peripheral and central airway smooth muscle mass decreased similarly in both groups. Despite a better control of airway neutrophilia, azithromycin did not potentiate the other clinical effects of fluticasone.

Effect of combined glucocorticoid therapy on bronchial asthma dynamics

This work is aimed to compare the effectiveness of parenteral and inhalation bronchial asthma treatment in combination with glucocorticosteroids and bronchodilators. The study was conducted in 2020 in Botkin City Clinical Hospital (Moscow, the Russian Federation). Case histories of 106 patients diagnosed with bronchial asthma exacerbation of moderate severity were analyzed. Patients were divided into two equal groups based on the therapy method: (1) Group 1 received systemic glucocorticosteroids parenterally in combination with inhalation glucocorticosteroids; (2) Group 2 received systemic glucocorticosteroids parenterally, but inhalation therapy was performed with a nebulizer. Clinical manifestations of bronchial asthma have been recorded. During hospital admission, the breath rate was 22.0 for Group 1 and 21.5 for Group 2, P ≥ 0.05, and heart rates were 93.0 and 92.5, respectively (P ≥ 0.05). All indices (blood saturation, breath rate, peak output rate) in Group 1 remained unchanged 4 h after the start of the therapy, while in Group 2, peak flow rate changed to 53.5% with a median increase of 72.0 ml over 4 h, P ≤ 0.05. On Day 3, patients of Group 1 demonstrated a peak flow rate of 59.5%, P ≤ 0.05, and on Day 10, patients of Group 2 had a peak output rate of 53.0 and 59.5%, respectively (P ≤ 0.05). Systemic glucocorticoids were eliminated in 47 patients of Group 1 and in all patients of Group 2. The treatment tactics applied in Group 2 resulted in faster and more significant improvement in patients diagnosed with bronchial asthma exacerbation. Both treatment regimens showed high results (AU)