Pulmonary Therapy最新文献

{"title":"Oscillating Positive Expiratory Pressure (OPEP) Therapy in Bronchiectasis and Chronic Obstructive Pulmonary Disease (COPD): A Narrative Review of Clinical Studies.","authors":"Judy L Schloss, Dominic P Coppolo, Jason A Suggett, Breeanna R Long, Mark W Nagel, Jolyon P Mitchell","doi":"10.1007/s41030-026-00354-1","DOIUrl":"10.1007/s41030-026-00354-1","url":null,"abstract":"<p><p>Exacerbations associated with bronchiectasis with or without chronic obstructive pulmonary disease (COPD) are often associated with generation and accumulation of excessive mucus in the airways of the lungs. Not only can mucus plugs reduce the perfusion of oxygen to the alveolar gas exchange region but they also serve as a location for opportunistic bacterial/viral infection. Delivery of inhaled medications to treat receptors associated with the underlying COPD distal to the obstructed airways can be restricted or prevented altogether. This narrative review examines clinical evidence published mainly since 2004 for the use of oscillating positive expiratory pressure (OPEP) as a drug-free airway clearance therapy (ACT) for patients experiencing COPD with or without bronchiectasis. OPEP therapy is considered as a preventative measure in between exacerbations and to clear the airways during severe exacerbations. The review is intended to assist clinicians involved with COPD-bronchiectasis management, given the increased awareness of the advantages of OPEP therapy in clinical practice guidelines.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"485-533"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Term Adherence to Elexacaftor/Tezacaftor/Ivacaftor in People with Cystic Fibrosis.","authors":"Carina M E Hansen, Badr Zendaky, Annelies M Zwitserloot, Patricia M L A van den Bemt, Job F M van Boven","doi":"10.1007/s41030-026-00351-4","DOIUrl":"10.1007/s41030-026-00351-4","url":null,"abstract":"<p><strong>Introduction: </strong>Cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulators are the cornerstone treatment for CF, but nonadherence can reduce their effect. Long-term adherence data on elexacaftor/tezacaftor/ivacaftor (ETI) combined with the evening dose ivacaftor (IVA) are lacking. The aim of this study was to determine 3-year adherence to ETI and IVA based on pharmacy refill data.</p><p><strong>Methods: </strong>A retrospective observational cohort study was conducted using pharmacy refill data. Medication adherence was calculated using the proportion of days covered (PDC). The primary outcome was the PDC for ETI and IVA, which were calculated at 1, 2, and 3 years after initiating ETI and IVA. The secondary outcome was the proportion of non-adherent people with CF (pwCF), defined as having a PDC < 0.8.</p><p><strong>Results: </strong>A total of 128 pwCF were included (75 male [59%], mean age 28.8 ± 15.5 years). At year 1, the PDCs for ETI and IVA (N = 128 and 112) were (median, range) 0.98 (0.69-1.0) and 0.98 (0.68-1.0); at 2 years (N = 105 and 95), 0.99 (0.54-1.0) and 1.0 (0.69-1.0), and at 3 years (N = 56 and 51), 0.98 (0.49-1.0) and 0.99 (0.54-1.0). Over time, a statistically significant decrease in PDC was observed [p = 0.01 (ETI, years 1 vs. 3) and p = < 0.01 (IVA)]. The percentage of non-adherent pwCF increased over time, from 3.6% (IVA) and 3.3% (ETI) at year 1 to 15.7% (IVA) and 12.5% (ETI) at year 3.</p><p><strong>Conclusions: </strong>Three-year adherence to ETI and IVA based on pharmacy refill data was high, yet declined over time.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"549-560"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287353/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147434839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peripheral Blood Inflammatory Markers and Immune Cell Profiles in Smokers With and Without COPD.","authors":"Wenying Lu, Maddison Waters, Josie Larby, Sapha Shibeeb, Steven Bozinovski, Stavros Selemidis, Jonathan McQualter, Ross Vlahos, Md Imtaiyaz Hassan, Heinrich Weber, Sukhwinder Singh Sohal","doi":"10.1007/s41030-026-00367-w","DOIUrl":"10.1007/s41030-026-00367-w","url":null,"abstract":"<p><strong>Introduction: </strong>Cigarette smoking is a major driver of airway and systemic inflammation and contributes to the development and progression of chronic obstructive pulmonary disease (COPD). This study compared peripheral blood inflammatory markers and immune cell profiles in smokers with and without COPD and in non-smoking controls.</p><p><strong>Methods: </strong>In this cross-sectional study, blood samples were collected from 80 participants (n = 20/group): non-smoker controls (NS), smokers with normal lung function (NLFS), current smokers with COPD (COPD-CS), and ex-smokers with COPD (COPD-ES). Total white cell count (WCC) and leukocyte differentials (neutrophils, lymphocytes, monocytes, eosinophils) were measured using an automated haematology analyser (Sysmex XN2000). Systemic inflammatory markers were measured using C-reactive protein (CRP, Roche Cobas Pro) and erythrocyte sedimentation rate (ESR, Diesse VES-MATIC Easy). Lung function parameters (including FEV1, FVC, DLco, FEF25-75%, and SpO2) were assessed and correlated with blood markers.</p><p><strong>Results: </strong>Compared with NS, WCC, neutrophils, and monocytes were higher in both COPD groups and in NLFS (all p < 0.05). Lymphocytes were higher in NLFS and COPD-CS (p < 0.05). Eosinophils were higher in COPD-ES and NLFS relative to NS (p < 0.05). ESR and CRP were elevated in NLFS and both COPD groups compared with NS (p < 0.05). In COPD, higher blood inflammatory cell counts were associated with poorer lung function (negative correlations; p < 0.05).</p><p><strong>Conclusion: </strong>Peripheral blood inflammatory markers are increased in smokers, including those with preserved lung function, and in COPD. Differences in eosinophil patterns between COPD current smokers and ex-smokers suggest inflammatory heterogeneity and should be confirmed in larger, well-characterized cohorts. These findings support the move towards careful personalized medicine interventions, based on individual inflammatory profiles.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"637-652"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287509/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147974869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Characteristics and Healthcare Resource Use among Patients With COVID-19 Receiving Treatment with Nirmatrelvir/Ritonavir (PAXLOVID™) in the Kingdom of Saudi Arabia.","authors":"Basem M Alraddadi, Reem S Almaghrabi, Mohammad Bosaeed, Mohamed Kamal, Ashraf Hassanien, Haridy Hammam, Giovanni Zanotti, Burcu Karakuzu Ikizler, Florence Lefebvre d'Hellencourt, Julia Regazzini Spinardi, Lu Wang, Moe H Kyaw","doi":"10.1007/s41030-026-00360-3","DOIUrl":"10.1007/s41030-026-00360-3","url":null,"abstract":"<p><strong>Introduction: </strong>Real-world evidence for the use of nirmatrelvir/ritonavir in routine clinical practice remains limited in the Kingdom of Saudi Arabia (KSA). This study aimed to describe the demographic and clinical characteristics, treatment patterns, and healthcare resource utilization (HCRU) of adult patients with coronavirus disease 2019 (COVID-19) prescribed nirmatrelvir/ritonavir in the KSA.</p><p><strong>Methods: </strong>This was a multicenter, retrospective observational cohort study, including adult patients with COVID-19 who were prescribed nirmatrelvir/ritonavir between April 2022 and June 2024. Data were collected through an electronic case report form from patients' electronic medical records and included patient demographics, clinical characteristics, vaccination history, prescribing characteristics, and HCRU. Data were collected from the index date, defined as the date of nirmatrelvir/ritonavir prescription, up to 30 days post-index. Descriptive analyses were conducted to summarize patient and clinical characteristics, treatment patterns, and HCRU. Logistic regression models were used to assess associations between patient characteristics and COVID-19-related hospitalization at the index date.</p><p><strong>Results: </strong>A total of 248 patients were included. The mean age was 49.9 years, 59.7% of patients were women, and 90.3% had at least one comorbidity. At the index date, 48.4% of patients were hospitalized, with 60.0% of hospitalizations related to COVID-19. Within 30 days post-index, 9.3% of patients had a documented hospitalization, of which 8.7% were COVID-19-related. In multivariable analysis, patients aged 50-64 years had a lower likelihood of COVID-19-related hospitalization at the index date compared with those aged 18-30 years (odds ratio 0.33; 95% confidence interval [CI] 0.11-0.99).</p><p><strong>Conclusion: </strong>This study revealed a relatively young adult patient population with a high rate of hospitalization at the time of nirmatrelvir/ritonavir initiation. Older age (50-64 years) was associated with a lower likelihood of COVID-19-related hospitalization at the index date. Further research is needed to better characterize the real-world use of nirmatrelvir/ritonavir and to investigate its potential benefit among hospitalized patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT06016556.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"617-635"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287346/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147974861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"2025 Annual Review of Pulmonary Arterial Hypertension Clinical Research.","authors":"Ilma Alves de Oliveira Nascimento, Rogério Souza, Caio Júlio Cesar Dos Santos Fernandes","doi":"10.1007/s41030-026-00359-w","DOIUrl":"10.1007/s41030-026-00359-w","url":null,"abstract":"<p><strong>Introduction: </strong>Pulmonary arterial hypertension (PAH) remains a progressive and life-threatening disease despite major therapeutic advances over the past three decades. Alongside evolving treatment strategies, the growing complexity of PAH management has been accompanied by an expansion of global clinical research activity, creating challenges for clinicians and researchers to synthesize emerging evidence and identify meaningful trends.</p><p><strong>Methods: </strong>This study provides a descriptive analysis of PAH-related clinical studies registered on international platforms integrated into the World Health Organization International Clinical Trials Registry Platform (ICTRP/WHO) between January and December 2025. Trials were characterized according to study design, therapeutic pathway, geographic distribution, funding source, and methodological features, including endpoint selection and incorporation of patient-reported and digital outcomes.</p><p><strong>Results: </strong>A total of 54 PAH-related studies were registered in 2025, of which 64.8% were interventional and 33.3% observational. Most trials involved pharmacological interventions and were conducted predominantly in high- and middle-income countries, with limited representation from low-income regions. Academic institutions and hospitals accounted for the majority of sponsors, while direct pharmaceutical industry sponsorship was identified in a minority of registrations. Therapeutic investigations extended beyond classical vasodilator pathways, with increased focus on transforming growth factor/bone morphogenetic protein (TGF-β/BMP) signaling modulation, metabolic and cardiorenal pathways, and selective tyrosine kinase inhibition. Methodologically, trials increasingly incorporated composite endpoints, imaging-based assessments, biomarkers, patient-reported outcome measures, and, in a subset, digital health and remote monitoring strategies.</p><p><strong>Conclusion: </strong>Clinical trials registered in 2025 reflect a PAH research landscape characterized by stable trial volume, diversification of therapeutic targets, and progressive methodological refinement. The growing use of multidimensional endpoints and patient-centered and digital tools suggests a increasing integration of therapeutic response. Persistent gaps in geographic representation and endpoint standardization, however, remain key challenges for the future of PAH clinical research.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"463-483"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287177/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147639693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Practical Considerations for Managing Transitions from Parenteral Prostacyclins to Oral Selexipag in Pulmonary Arterial Hypertension.","authors":"Jean M Elwing, Christina Benninger, Paul Strachan, Korawin Triyasakorn, Marla Choren, B Kody Timms, Lori Reed","doi":"10.1007/s41030-026-00357-y","DOIUrl":"10.1007/s41030-026-00357-y","url":null,"abstract":"<p><p>The prostacyclin pathway represents a foundational pathway in the treatment of patients with pulmonary arterial hypertension (PAH). Parenteral prostacyclin pathway agents (PPAs) are often used for treatment of severe PAH but their broader use is limited by administration difficulties, including a need for continuous infusion, administration side effects, and complexities of a chronic indwelling catheter. Administration of the prostacyclin receptor agonist selexipag, an oral therapy with more than 10 years' clinical experience, may be more favorable for some patients. However, treatment protocols for transitioning from parenteral PPAs to oral selexipag are lacking. Here, we describe practical considerations for managing such transitions. The transition process requires an individualized and shared decision-making approach between the patient and multidisciplinary team to optimize treatment outcomes. Key considerations include patient selection criteria, setting expectations, transition setting (inpatient vs outpatient), transition speed, dose adjustment, and clinical follow-up. Appropriate patient candidates for transition to oral selexipag should be clinically stable and selected based on a comprehensive evaluation using validated risk scores and hemodynamic parameters. Expectations and realistic treatment goals should be discussed collaboratively and must include the possibility of returning to parenteral PPAs if clinically indicated. Transition protocols should be flexible and tailored to each patient. Outpatient transition may be considered depending on transition speed, the patient's ability to follow dosing instructions, and access to emergency care if needed. Speed of the transition to oral selexipag varies based on individual patient needs. Close monitoring and long-term follow-up are essential following transitions to maximize success and patient safety. In summary, transitioning from parenteral PPAs to oral selexipag can be challenging and complex. However, success is achievable for suitable patients through careful planning, setting transparent expectations, and an individualized approach with close monitoring and long-term follow-up.Graphical abstract available for this article.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"425-435"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287317/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147639750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Outcomes across Baseline Risk Profiles in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate in Spain: Insights from the ORESTES Study.","authors":"Bernardino Alcázar-Navarrete, Juan Marco Figueira-Gonçalves, Nagore Blanco Cid, Nuria Bruguera Avila, Roberto Bernabeu Mora, Antonia Fuster Gomila, Raúl Galera Martínez, Marta M García Clemente, Galo Granados, Hassan Khadour Khadour, Eduardo Márquez-Martín, Igor Murga Arizabaleta, Jose Luis Velasco Garrido, Carmen Corregidor-García, Eunice Fitas, Joaquín Sánchez-Covisa","doi":"10.1007/s41030-026-00366-x","DOIUrl":"10.1007/s41030-026-00366-x","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder characterized by persistent symptoms such as dyspnea and cough, as well as exacerbations. Triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) is recommended for patients not adequately controlled by dual therapy. Key clinical parameters guide COPD management.</p><p><strong>Methods: </strong>The observational, retrospective ORESTES study included adults ≥ 40 years with COPD initiating BGF in routine practice. In this analysis, patients were grouped according to exacerbation history, airflow obstruction (forced expiratory volume in 1 s [FEV₁] % predicted), and blood eosinophil count. Exacerbations, additional COPD medications, and healthcare resource utilization (HCRU) were evaluated.</p><p><strong>Results: </strong>Among 114 patients with only one moderate exacerbation (and no severe exacerbations) and 363 with ≥ 1 severe and/or ≥ 2 moderate exacerbations in the previous year, the proportion experiencing at least one exacerbation decreased by 43.9% and 35.0% (relative differences), respectively, after BGF initiation. Regarding airflow obstruction, reductions were 22.3% for patients with FEV₁ < 50% predicted (N = 156) and 24.0% for those with FEV₁ ≥ 50% predicted (N = 155). According to blood eosinophil count, decreases were 29.8% (< 100 cells/µL, N = 110) and 25.8% (≥ 100 cells/µL, N = 208). Across all subgroups, reductions in moderate and severe exacerbations ranged from 18.9% to 54.4% and from 10.9% to 45.5%, respectively, except for the expected increases in severe events and related hospitalizations in the group with only one prior moderate exacerbation. Use of rescue medication (including short-acting beta-2 agonists [SABA]), emergency room visits, and hospitalizations generally declined, with reductions across subgroups ranging from 7.8% to 45.5%.</p><p><strong>Conclusion: </strong>Consistent improvements were observed across all subgroups, with reductions in exacerbations, rescue medication use, and HCRU regardless of prior exacerbation history, lung function, or blood eosinophil levels. These findings suggest that BGF may lead to improvements across a broad disease spectrum, further supporting the hypothesis that earlier introduction may be beneficial.</p><p><strong>Trial registration: </strong>NCT06321731.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"667-689"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287286/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148143912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potential Public Health Impact of Updated COVID-19 Vaccination Strategies in Thailand: Epidemiological Data Update.","authors":"Karan Thakkar, Ruangwit Thamaree, Moe H Kyaw, Iustina Chirila, Carlos Fernando Mendoza, Josie Dodd, Ben Yarnoff, Sasisopin Kiertiburanakul","doi":"10.1007/s41030-026-00358-x","DOIUrl":"10.1007/s41030-026-00358-x","url":null,"abstract":"<p><strong>Introduction: </strong>This study evaluates the anticipated health and economic effects of multiple COVID-19 vaccination strategies using an updated vaccine in Thailand.</p><p><strong>Methods: </strong>A previously published hybrid decision tree and Markov model, originally developed for the USA, was calibrated using Thailand-specific epidemiological, demographic, and economic data from 2024. The model assessed several age- and risk-based vaccination strategies assuming vaccine uptake ranging from 20% to 50%. Health outcomes (cases, hospitalizations, deaths, and long COVID cases) and economic outcomes (long COVID costs, direct medical costs, and productivity losses) were projected from payer and societal perspectives. Vaccine effectiveness was assumed to be 50% against infection, 60% against symptoms, and 70% against severe disease, with a 6-month duration of protection.</p><p><strong>Results: </strong>Vaccinating individuals aged 60 years and above and high-risk individuals aged 6 months to 59 years was projected to prevent 318,700 infections, 9147 hospitalizations, and 1061 deaths in 1 year. This strategy was estimated to yield THB 3300 million in direct medical cost savings and THB 2695 million in productivity loss savings. Increasing coverage in this population to 50% could amplify these reductions by up to 150%.</p><p><strong>Conclusions: </strong>With updated Thai data, analyses suggest that use of an adapted COVID-19 vaccine could continue to generate considerable public-health and economic gains, particularly when coverage among older adults and high-risk groups is expanded. These findings carry implications for sustaining preparedness and guiding national vaccination policy.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"573-584"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287513/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147574397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Three Devices Preventing Skin Damage During Facial Mask Ventilation in Acute Respiratory Failure: Multicenter Randomized Controlled Trial Protocol (3PROSNIVtrial).","authors":"Raffaele Scala, Federica Andolfi, Giulia Ottaviano, Teresa Renda, Elena Ceparano, Manuela Caneschi, Luca Guidelli, Maria Laura Vega, Lara Pisani, Ilaria Bassi, Alfredo Aprile, Stefania Bertini, Daniela Bonanni, Patrizia Zoccali, Michele Vitacca, Luca Barbano, María Torrano Ferrández, Ana Rozúa López, Genoveva Ruiz Villa, Santino A Marchese, Geraldine Lo Grasso, Elisabetta Fiandra, Elvio Scoscia, Amir Eslami, Emanuela Albo, Stefano Baglioni, Nicola Facciolongo, Claudia Castagnetti, Chiara Barbieri, Fabio Boccafoglio, Sonia Viola, Antonio M Esquinas","doi":"10.1007/s41030-026-00364-z","DOIUrl":"10.1007/s41030-026-00364-z","url":null,"abstract":"<p><strong>Background: </strong>In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV), pressure-related skin injury is among the most frequent and clinically relevant complications. The reported prevalence of device-related pressure injuries is estimated at around 25%, while reported incidences of NIV-related facial pressure ulcers range from approximately 10-31%. These lesions, mainly localized over the nasal bridge, arise because the skin in this area is thin and supported by minimal subcutaneous tissue, making it highly vulnerable to ischemic and frictional forces exerted by the mask interface. In severe cases, skin breakdown may lead to pain, infection, or discontinuation of NIV, thereby compromising ventilatory support. The most commonly adopted preventive strategy involves the application of shaped hydrocolloid dressings; however, evidence regarding their actual effectiveness and the potential benefits of alternative protective devices remains limited.</p><p><strong>Objectives: </strong>The primary aim of this study is to compare skin injury-free survival in ARF patients receiving NIV treated with three different CE-marked protective systems. Secondary objectives include assessing device stability and protective performance, patient comfort, pain intensity, mask tolerance, timing and staging of skin lesions, cost-effectiveness, predictive factors for skin injury, and overall NIV success.</p><p><strong>Methods: </strong>This is a multicenter, randomized, open-label, controlled trial involving 14 Italian pulmonology intensive care units and 1 Spanish Intensive Care Unit. Eligible patients with hypoxemic or mixed hypoxemic-hypercapnic ARF requiring NIV for more than 24 h will be randomly assigned to one of four study arms (three intervention groups and one control group). Each group will receive a different protective device-Tegaderm^®, Duoderm^®, or Allevyn Adhesive^®-or standard care. Lesion grading, pain assessment, and device performance will be evaluated using standardized scoring systems.</p><p><strong>Planned outcomes: </strong>The trial will provide comparative evidence on the efficacy of different protective dressings in preventing NIV-related facial skin injury, thereby supporting the development of evidence-based recommendations for clinical practice.</p><p><strong>Trial registration: </strong>NCT01351155.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"721-731"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287532/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global pMDI Use and the Potential Impact of European PFAS Legislation on Access to These Essential Inhaled Medications.","authors":"Janwillem W H Kocks, Tim Harrison, John P Bell, Andy Rignall, Mina Khezrian, Omar S Usmani","doi":"10.1007/s41030-026-00362-1","DOIUrl":"10.1007/s41030-026-00362-1","url":null,"abstract":"<p><strong>Introduction: </strong>Many essential inhaled medicines recommended in guidelines are delivered to the lung via pressurized metered-dose inhalers (pMDIs). Global environmental legislation will lead to phasing out of hydrofluoroalkane propellants currently used in pMDIs, owing to their global warming potential (GWP). Furthermore, the European Chemicals Agency is reviewing proposed legislation to ban per- and polyfluoroalkyl substances (PFAS) on the basis of chemical structure, which could also impact pMDI availability. Here, we estimated pMDI use as a proportion of all inhaler use in 60 countries, spanning six geographical regions, to understand the relevance of any pMDI restrictions to patients and prescribers.</p><p><strong>Methods: </strong>pMDI use as a percentage of total inhaler use during 2022 was calculated by country and geographical region using inhaler sales data (a surrogate of use) from the IQVIA Quarterly MIDAS database; inhaler use for the 10-year period from 2013 to 2022 was also evaluated for these regions. Data were compared by individual inhalations. The total patient population living with asthma and/or chronic lower respiratory disease was calculated on the basis of Eurostat (the statistical office of the European Union [EU]) 2019 data and available disease prevalence statistics. Maintenance pMDI utilization was estimated by adjusting for ratio of maintenance pMDI use to total inhaler use.</p><p><strong>Results: </strong>Across all countries analyzed, pMDIs accounted for the largest proportion of inhaler use in 2022 (77.3%). In 51 out of 55 countries with available country-level data, pMDIs represented > 50% of total inhaler use. After adjusting for pMDI usage, an estimated 8.1 million EU patients received a maintenance pMDI in 2022, with the greatest proportion in Germany and France.</p><p><strong>Conclusions: </strong>pMDIs are vital inhalers for most patients in Europe and around the world. While transitioning to near-zero or low-GWP inhalers, it is essential to avoid unintended consequences from the proposed PFAS ban by safeguarding patient access to this essential device option.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"653-666"},"PeriodicalIF":3.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13287505/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148227778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}