This study explores the relationship between patient activation, adherence behaviors, asthma knowledge, and response to monoclonal antibody (mAb) therapy in severe eosinophilic asthma (SEA). Despite advances in mAb therapies, some SEA patients continue to experience uncontrolled symptoms. Understanding these factors could lead to more effective, personalized treatment strategies. Participants diagnosed with SEA and undergoing mAb therapy for 6-9 months were recruited from three German university outpatient clinics. They were categorized using the Biologics Asthma Response Score (BARS) into responders, partial responders, and non-responders. Data collection focused on demographic details, lung function, medication history, patient activation (PAM13-D), and adherence (A14 questionnaire). Statistical analyses assessed the impact of adherence and knowledge on treatment outcomes. Of the 140 participants, 61% were responders, 24% partial responders, and 15% non-responders. Age, sex distribution, smoking status, pack-years, eosinophil levels, ExNO and lung function parameters were comparable across response groups. A14 scores and asthma knowledge differed significantly across response groups, whereas PAM13-D did not. In ordinal logistic regression, asthma knowledge remained associated with BARS-defined response category after adjustment. A negative attitude towards drugs was associated with response category in univariate analysis, but this association was attenuated after adjustment. Better asthma knowledge was associated with BARS-defined response to mAb therapy, while PAM13-D and overall A14 score were not independently associated with response. Medication attitude may still be clinically relevant, but their association with response should be interpreted cautiously. These findings support a patient-centered approach that considers asthma knowledge, adherence-related behaviors and medication attitudes during biologic treatment. Prospective studies are needed to determine whether targeted education and adherence support can improve clinical outcomes.
Patients with chronic obstructive pulmonary disease (COPD) frequently suffer from other chronic conditions, with cardiovascular disease being especially common. The presence of cardiovascular disease in patients with COPD complicates overall disease management and is associated with worse morbidity and high mortality. Furthermore, patients who are hospitalised due to a COPD exacerbation are at an increased risk of death not only during hospitalisation but also for at least one year post-discharge, with the coexistence of cardiovascular comorbidities being key predictors of poor medium-term outcomes. Importantly, cardiovascular disease is often undiagnosed in patients with COPD - and even if diagnosed, medical care during and after hospitalisation often focuses on a single condition without structured coordination between hospital- and office-based physicians. This narrative review aims to provide practical guidance to primary and (non-specialist) secondary care physicians who are caring for patients with COPD and cardiovascular comorbidities, including the discharge process and the post-hospitalisation period. Limited data are available to support some of these recommendations, and the content therefore represents expert consensus based on collective experience and practice.
Purpose:To collect prospective data from asthma patients treated with medium- (87/5/9µg) or high-strength (172/5/9µg) extrafine single-inhaler beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G, Trimbow®) in a real-world setting. Patients and Methods:TriMaximize is a non-interventional, prospective, multicenter study conducted in eight European countries (enrollment: 2021-2024). The primary objective was to describe patient characteristics and therapy pathways for adult patients with moderate to severe asthma treated with BDP/FF/G for up to 36 months. Assessments included demographic/clinical characteristics, pulmonary parameters, treatment pathways, asthma control measured by asthma control test (ACT), and health-related quality of life (HrQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini-AQLQ). Results:In total, 1,445 patients (62.8% female; mean age: 57.6 years) were included. Before medium-strength BDP/FF/G initiation, 75.7% of the patients received a fixed ICS/LABA combination. Most patients starting with high-strength BDP/FF/G received fixed ICS/LABA (52.9%) or free ICS/LABA/LAMA (43.2%) combinations as prior therapy. Throughout the study, 87.1% of the patients remained on BDP/FF/G. At month 12, fewer patients (12.4%) used systemic corticosteroids (SCS) compared to baseline (33.2%). Use of rescue medication declined from 6.1 (baseline) to 3.6 puffs/week (month 12). During the first year, 79.5% of the patients experienced neither exacerbations nor used SCS. Three-component clinical remission was achieved in 45.6% (first year) and 59.3% (second/third year) of the patients. Four-component clinical remission was accomplished in 39.5% (first year) and 47.9% (second/third year). Improvements in asthma control (mean ACT change at month 12: 3.9; month 36: 4.8, p<0.0001) and HrQoL (mean Mini-AQLQ change at month 12: 0.8; month 36: 0.9, p<0.0001) exceeded the respective minimal clinically important differences. Forced expiratory volume in 1 second increased by 142 mL after 12 months (p<0.0001). Conclusion:Extrafine, single-inhaler BDP/FF/G therapy was effective and safe in a routine clinical practice setting in a multi-national cohort of patients with moderate to severe asthma.
Rationale: Asthma and Chronic Obstructive Pulmonary Disease (COPD) are distinct conditions, but they can coexist in patients, with the prevalence of these cases increasing from mid to late life. They present particular diagnostic and therapeutic challenges with similar symptomatology and mechanistic interactions. Triple combination therapies are often used in this setting while existing data is limited. For example, the clinical development program of the single-inhaler beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) in asthma did not include patients with concomitant COPD. Therefore, we aimed to investigate the effect of BDP/FF/G in a real-world setting of patients with both asthma and COPD. Methods: TriMaximize is an observational study following asthma patients prescribed BDP/FF/G over 1-3 years. Patients were recruited at 125 sites across Germany, United Kingdom, Austria, Denmark, France and Spain. Asthma control is assessed by the Asthma Control Test (ACT) and Health-Related Quality of Life is evaluated by Mini Asthma Quality of Life Questionnaire (Mini AQLQ). Pre-bronchodilator lung function was assessed by spirometry and body plethysmography. Results: We present data from 419 asthma patients in this 6-month interim analysis, of whom 116 (27.7%) had reported concomitant COPD. Mean baseline ACT score was 13.5(±4.2) points in the Asthma-COPD group and 14.9(±4.8) points in the Asthma-only group. After six months of treatment, the ACT score improved by 4.5(±4.5) points in Asthma-COPD group and 3.7(±4.7) points in Asthma-only group (between-group p<0.11). Mean baseline Mini AQLQ was 4.0(±1.1) points in the Asthma-COPD group and 4.4(±1.2) points in the Asthma-only group. Mini-AQLQ scores improved by 0.9(±1.1) points in Asthma-COPD group and by 0.7(±1.0) points in the Asthma-only group (between-group p<0.12). Both improvements exceeded the minimal clinically important differences for ACT (3 points) and Mini AQLQ (0.5 points). The Asthma-only group showed an increase from baseline by 110 ml in FEV1, 120 ml/s in MEF 25-75 and a decrease of 0.16 (kPa[asterisk]s) in sRtot and 1.43% points in RV/TLC. Similar effects were observed in Asthma-COPD group, with an increase of 130 ml in FEV1 (between-group p=0.72), 100 ml/s in MEF 25-75 (between-group p=0.92) and a decrease of 0.14 (kPa[asterisk]s) in sRtot (between-group p=0.90) and 3.12 % points in RV/TLC (between-group p=0.35). Conclusion: Significant improvement in asthma control, quality of life and lung function can be seen six months after initiating treatment with BDP/FF/G. Effects were similar in patients with and without concomitant COPD. This indicates comparable efficacy in this clinically relevant yet under-investigated subgroup in a real-world setting.
Patients with lung or hematological malignancies face an elevated risk of severe COVID-19 outcomes. While machine learning frameworks offer predictive utility, training a single joint clinical-biological model on heterogeneous cancer populations can introduce structural feature selection bias, limiting clinical generalizability. Utilizing a multicenter retrospective cohort (n = 340) for model development and an independent external cohort (103) for validation, we evaluated an end-to-end machine learning pipeline. Initially, a joint 7-variable signature—comprising age, ECOG performance status, lymphopenia, BMI, albumin, creatinine, and SARS-CoV-2 serology—was analyzed using logistic regression (LR) and random forest (RF) algorithms. Phenotypic deconstruction via cluster-level ablation and cancer-type-stratified optimal feature searches were subsequently executed to evaluate population-specific feature mechanics. The primary joint LR model achieved an optimism-corrected internal AUC of 0.75 (95
Introduction:It has been proposed that patients with asthma on monoclonal antibodies (mAb) targeting Interleukin-5 (IL-5), IL-4/IL-13 pathways or IgE may demonstrate insufficient defense against viral infections requiring strong T-helper-cell-type-1-(Th1) for neutralizing antibody production and cytotoxic CD8+ T-cell responses for efficient clearance of the viral pathogens. It is a matter of debate whether those mAb may impair the immune response against SARS-CoV-2-spike-protein by interacting with cytokines critical for B-cell differentiation and antibody maturation. This controlled cross-sectional cohort study aimed to characterize the mucosal and serum humoral immune response as well as the cellular reactivity against spike-protein in asthma patients on mAb or on conventional treatment (conv). Materials and Methods:Nasal and serum anti-spike-IgG and -IgA concentrations, avidity, neutralizing IgG and cytokine profiles were assessed using serological and neutralization assays and bead-based cytokine detection in nine patients on mAb matched to nine patients on conv who had received COVID-19-mRNA-vaccination. Proportions of spike-induced subpopulations of T- and B-cells were investigated by flow cytometry. Results:Blockade of IL-5 and IL-5 receptor showed higher serum and nasal concentrations of anti-spike-IgA against recombinant-binding-domain-(RBD) and spike-protein-1-(S1) and similar concentrations of anti-spike-IgG compared to mAb or conv therapy. A spike-specific CD8+ T-cell-driven immune response with increased cytotoxic markers was seen in anti-IL-5 treatments. Baseline Th1 responses correlated with IFNγ- and TNFα-production in supernatants of spike-protein-stimulated cultures in all patients. Conclusion:The findings indicate a significant specific adaptive immune response to SARS-CoV-2-spike-protein exposures by Th1- and Th2-driven responses with a significant response by serum and mucosal anti-S1 and anti-RBD-IgA in anti-IL-5-treated patients compared to IL-4/IL-13-targeting, anti-IgE or conventional therapies. Thus, based on the results it may be expected that immunogenicity of COVID-19-mRNA-vaccines or infection-induced spike-exposures is equivalent between asthma patients on monoclonal antibodies compared to those treated with conventional therapy.
Zusammenfassung Die Aerosoltherapie ist ein essenzielles Verfahren in der Behandlung akuter und chronischer Atemwegserkrankungen. Derzeit existiert keine aktuelle Leitlinie aus den deutschsprachigen Ländern zur Auswahl und Anwendung von Verneblersystemen bei Patienten unter High-Flow-Therapie via Nasenkanüle (HFT) und nichtinvasiver Beatmung (NIV). Ein interdisziplinäres Expertengremium aus Pneumologen und Intensivmedizinern entwickelte praxisorientierte Empfehlungen zur Aerosoltherapie unter HFT und NIV. Die Evidenzgrundlage bildete eine systematische Recherche in der Datenbank PubMed der US National Library of Medicine bis einschließlich November 2025.Einbezogen wurden Publikationen zu klinischen Studien, Übersichtsarbeiten, Leitliniendokumente und technische Berichte. Der jeweilige Evidenzgrad der Informationen wurde bewertet. Die Empfehlungen wurden in einem Mehrstufenverfahren konsentiert. Die Aerosolapplikation unter HFT und NIV mit einem Vibrating-Mesh-Vernebler (VMN) führt zu einer besseren Lungendeposition im Vergleich zur Verwendung eines Jet Nebulizers (JN). Ein JN ist geeignet, wenn VMN nicht verfügbar sind, hochvisköse Medikamentenlösungen vernebelt werden sollen oder wenn budgetäre Limitationen bestehen. Die Wahl und Anwendung des Verneblersystems sollte patientenindividuell, indikationsbezogen und unter Berücksichtigung technischer, klinischer und ökonomischer Rahmenbedingungen erfolgen.
Background:Current guideline-based diagnosis of airflow limitation in COPD focuses on spirometry, which is insensitive to early small airway changes of symptomatic smokers or subjects at risk. Therefore, we sought to determine the frequency of small airways disease (SAD) in these groups compared with mild COPD, and evaluate associations with symptoms as well as health-related quality of life (HRQoL). Methods:Patients with mild COPD (post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) <70%, FEV1 ≥70% predicted) or (ex-)smokers at risk (post-bronchodilator FEV1/FVC ≥70%, ≥10 pack-years, COPD Assessment Test score ≥10 or long-acting bronchodilator treatment) were included in the Change in Airway Peripheral Tone in COPD (CAPTO-COPD) longitudinal observational study. Comprehensive lung function testing included conventional (spirometry, body plethysmography, diffusing capacity of the lung for carbon monoxide, exhaled nitric oxide fraction) and advanced techniques (oscillometry, multiple-breath washout). Results:We present cross-sectional baseline data from 90 COPD patients (mean±sd age 65±9 years; mean±sd FEV1 77±12% pred), 62 subjects at risk (60±10 years, 89±13% pred) and 59 controls (45±199 years, 98±12% pred). Abnormal SAD-values were found in up to 58% of (ex-)smokers at risk and 60% of COPD patients. Meaningful HRQoL differences were most pronounced for SAD-parameters of peripheral resistance (frequency dependence of resistance p=0.03) and elastic lung properties (reactance area p=0.06, resonance frequency p=0.01). Conclusion:SAD is common even in symptomatic (ex-)smokers not fulfilling spirometric criteria with a similar frequency and pattern as compared to mild COPD patients. SAD is associated with impaired HRQoL, even in patients without established COPD.
Background:Aerosol therapy is an essential procedure in the treatment of acute and chronic respiratory diseases. Currently, there are no up-to-date guidelines from German-speaking countries on the selection and use of nebulizer systems in patients undergoing high-flow therapy via nasal cannula (HFT) and non-invasive ventilation (NIV). Methods:An interdisciplinary panel of experts consisting of pulmonologists and intensive care physicians developed practice-oriented recommendations for aerosol therapy under HFT and NIV. The evidence base was derived from a systematic search of the PubMed database of the US National Library of Medicine up to and including November 2025.Publications on clinical studies, reviews, guideline documents, and technical reports were included. The respective level of evidence of the information was evaluated. The recommendations were agreed upon in a multi-stage process. Results:Aerosol administration under HFT and NIV with a vibrating mesh nebulizer (VMN) achieved better lung deposition compared to the use of a jet nebulizer (JN). A JN is suitable if VMNs are not available, if highly viscous drug solutions are to be nebulized, or if there are budgetary limitations. Conclusion:The choice and application of the nebulizer system should be patient-specific, consistent with the indication, taking into account technical, clinical, and economic requirements.
This is the 4th edition of the Cough Guidelines of the German Respiratory Society (DGP), written by and for respiratory, internal medicine, allergy, ear-nose-throat, gastroenterology specialists, speech therapists, and physiotherapists. In a modified Delphi process, the authors developed 12 key questions on classification, common causes of acute, subacute, and chronic cough: both as a symptom of respiratory diseases including the upper airways, reflux, and drug-related cough, and as a primary disease, i.e., unexplained chronic cough and refractory chronic cough due to hypersensitivity of the cough reflex. An in-person guideline conference followed to find evidence-based answers and recommendations, which were graded as strong, weak, or insufficient evidence for recommendation. A brief scientific background to the respective questions was then compiled by expert groups of authors. Diagnostic algorithms were created for acute, subacute, and chronic cough and reflux-related cough. The significantly reduced scope and improved overview make it easy to use it in daily practice. The guideline is available in digital form as a smartphone application (currently only in German): https://www.leila.de/de/.
Atrial fibrillation (AF) frequently occurs in patients with chronic obstructive pulmonary disease (COPD) and is associated with adverse clinical outcomes. We aimed to identify patients at risk for AF using amplified p-wave duration (APWD) analysis on electrocardiogram (ECG) as non-invasive tool to diagnose an atrial cardiomyopathy (AtCM) which is an established risk factor for AF. This subgroup analysis of the prospective COSYCONET cohort included 2,385 COPD patients from 31 study centers with baseline sinus rhythm ECG and at least one follow-up examination. Of these, 73 patients showed AF during follow-up and were propensity-score matched to controls. APWD was measured at baseline and future major adverse cardiac and cerebrovascular events (MACCE) and health related outcome were assessed. 219 COPD patients (70 [64–74] years, 79.5
The outcomes of prolonged weaning in a specialist weaning centre range from successful weaning to death. We aimed to identify indicators of the different outcomes. We analysed 915 patients who underwent prolonged weaning at Thoraxklinik Heidelberg from Dec. 2008 to Dec. 2023. 73.2% were successfully weaned, 36.1% without (3a) and 37.1% with subsequent non-invasive ventilation (3b). 20.2% were discharged with IMV (3cI) and 6.6% died (3cII). The length of stay was significantly longer in the group discharged with IMV. Patients in weaning category 3a had fewer comorbidities, also as cause of IMV and were less obese (each at least OR ≤ 0.6, p ≤ 0.02). IMV before admission in days was significantly shorter, FiO2 higher and pCO2 lower, although with a weak effect (OR between 1.014 and 0.971). Indicators of category 3b were younger age (weak effect, OR 0.977), BMI ≥ 30 kg/m2 (OR 2.470, p < 0,001), higher pCO2 (OR 1.044), cause of IMV AECOPD (OR 2.803), pre-diagnosis of COPD (OR 2.073) and nosocomial pneumonia (OR 1.857), whereas patients with malignancy (OR 0.438) and CIP (critical illness polyneuropathy, OR 0.523) were less likely to fall into this category. Indicators of category 3cI were duration of previous IMV with a weak effect (OR 1.006), neuromuscular disease as the cause of IMV (OR 6.023), restrictive thoracic disease (OR 2.330), renal insufficiency (OR 1.977) and CIP (OR 1.744), absence of nosocomial pneumonia (OR 0.366). Only BMI ≤ 20 kg/m2 (OR 3.611), renal insufficiency (OR 1.253) and pre-diagnosed malignancy (OR 1.785) were indicators of category 3cII. The relevant indicators from multivariate analyses were transferred into ROC (receiver operating characteristic) curves and show an acceptable AUC (area under curve) between 0.72 and 0.79 for each of the four outcomes. There are specific indicators for each weaning outcome and an early assessment of each patient’s individual risk profile can help plan further outpatient care, shorten length of stay in the ventilator weaning unit and generate capacities for other patients in need of prolonged weaning.