ERJ Open Research最新文献

{"title":"AERIFY-1/-2: 2 phase 3 randomised controlled trials of itepekimab in former smokers with moderate-to-severe COPD","authors":"Klaus F. Rabe, Fernando J. Martinez, Surya P. Bhatt, Tomotaka Kawayama, B. Cosío, Robert M. Mroz, Maarten M. Boomsma, Helene Goulaouic, M. Nivens, Michel Djandji, Xavier Soler, Ying Liu, M. Kosloski, Christine R. Xu, Nikhil Amin, H. Staudinger, David J. Lederer, R. Abdulai","doi":"10.1183/23120541.00718-2023","DOIUrl":"https://doi.org/10.1183/23120541.00718-2023","url":null,"abstract":"Accumulating data implicate interleukin (IL)-33, a proinflammatory cytokine released locally upon epithelial cell damage, in the pathogenesis of chronic obstructive pulmonary disease (COPD). In a phase 2 study, itepekimab, a human monoclonal antibody against IL-33, reduced exacerbations and improved lung function in a subgroup analysis of former smokers with COPD with an acceptable safety profile.The study designs of AERIFY-1 and AERIFY-2 are described in this article.:The primary objective of AERIFY-1/2 (NCT04701983/NCT04751487), two phase 3 randomized, double-blind, placebo-controlled trials, is to assess the efficacy and safety of itepekimabversusplacebo in a population of former smokers with moderate-to-severe COPD over up to 52 weeks. An additional secondary population of current smokers are being enrolled in AERIFY-2. These two studies will enrol patients (aged 40–85 years) with COPD and chronic bronchitis who had ≥2 moderate or ≥1 severe exacerbations within the previous year despite standard-of-care triple or double background therapy. All participants are required to have ≥10-pack year smoking history, and ≥6 months since smoking cessation for former smokers. The primary endpoint is the annualized rate of moderate or severe acute exacerbation of COPD. Secondary endpoints include change from baseline in pre- and post-bronchodilator FEV1, and annualized frequency of severe exacerbations. Symptomatic endpoints include Evaluating Respiratory Symptoms in COPD, and St. George's Respiratory Questionnaire, safety and anti-drug antibody responses.","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140995177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comprehensive Geriatric Assessment for people with both COPD and frailty starting pulmonary rehabilitation: a mixed-methods feasibility trial","authors":"Lisa Jane Brighton, Catherine J. Evans, Morag Farquhar, K. Bristowe, Aleksandra Kata, Jade Higman, Margaret Ogden, C. Nolan, Deokhee Yi, Wei Gao, M. Koulopoulou, Sharmeen Hasan, Karen Ingram, Stuart F. Clarke, Kishan Parmar, Eleni Baldwin, C. Steves, William D-C Man, Matthew Maddocks","doi":"10.1183/23120541.00774-2023","DOIUrl":"https://doi.org/10.1183/23120541.00774-2023","url":null,"abstract":"Many people with COPD experience frailty. Frailty increases risk of poor health outcomes, including non-completion of pulmonary rehabilitation. Integrated approaches to support people with COPD and frailty throughout and following rehabilitation are indicated.To determine the feasibility of conducting a randomised controlled trial of integrating comprehensive geriatric assessment (CGA) for people with COPD and frailty starting pulmonary rehabilitation.Multicentre mixed-methods randomised controlled feasibility trial (“Breathe Plus”;ISRCTN13051922). People with COPD, aged ≥50, Clinical Frailty Scale ≥5, and referred for pulmonary rehabilitation were randomised 1:1 to usual pulmonary rehabilitation, or pulmonary rehabilitation plus CGA. Remote intervention delivery was used during Covid-19 restrictions. Outcomes (physical, psycho-social, service use) were measured at baseline, 90 and 180 days, alongside process data and qualitative interviews.Recruitment stopped at 31 participants (mean age 72.4 [sd10.1], 68% MRC 4–5), due to Covid-19-related disruptions. Recruitment (46% eligible recruited) and retention (87% at 90- and 180-day follow-up) were acceptable. CGAs occurred on average 60.5 days post-randomisation (range 8–129) and prompted 46 individual care recommendations (median 3 per participant, range 0–12); 65% of which were implemented during follow-up. The most common domains addressed during CGA were nutrition and cardiovascular health. Participants valued the holistic approach of CGA but questioned the optimal time to introduce it.Integrating CGA alongside pulmonary rehabilitation is feasible and identifies unmet multidimensional need in people with COPD and frailty. Given challenges around timing and inclusivity, the integration of geriatric and respiratory care should not be limited to rehabilitation services.","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140996885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Burden of Eosinophilic Granulomatosis with Polyangiitis in Europe","authors":"Rupert W. Jakes, Namhee Kwon, L. Huynh, J. Hwee, L. Baylis, R. Alfonso-Cristancho, Shawn Du, A. Khanal, M. Duh, Benjamin Terrier","doi":"10.1183/23120541.00912-2023","DOIUrl":"https://doi.org/10.1183/23120541.00912-2023","url":null,"abstract":"Real-world evidence characterising the burden of eosinophilic granulomatosis with polyangiitis (EGPA) in Europe is limited.To characterise patients in a large European EGPA cohort.This retrospective, non-interventional, longitudinal study recruited cross-specialty physicians from France, Germany, Italy, Spain, and the United Kingdom to conduct medical chart reviews for patients with a physician-confirmed diagnosis of EGPA. Patients were ≥12 years of age at diagnosis with ≥1 year of follow-up data from the first clinical visit with the physician (index date). Outcome measures collected from index date to end of follow-up included clinical manifestations and healthcare resource utilisation (HCRU).In total, 407 patient medical charts were reviewed by 204 physicians; median (interquartile range) duration of follow-up from index date was 2.2 (1.7, 3.5) years. Most patients (73.5%) had asthma. Patients underwent multiple diagnostic assessments, and 74.9% received ≥3 different therapies between diagnosis and end of follow-up (98.8% oral corticosteroids, 63.9% immunosuppressive therapies, 45.5% biologics). During follow-up, 84.5% of patients experienced EGPA clinical manifestations; most were considered moderate or severe and commonly affected the lungs (55.8%; including lung infiltrates: 25.8% and severe asthma: 24.8%), ear, nose, and throat (53.3%), and skin (41.8%). HCRU was substantial: 26.0% of patients made emergency department visits, 36.6% were hospitalised and 84.8% had outpatient visits.These real-world data show that EGPA presents a substantial burden to patients and the healthcare system. Earlier and better differential diagnosis and appropriate treatment may help reduce incidence of clinical manifestations and HCRU.","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141022946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world use of inhaled corticosteroid/formoterol as-needed in adults with mild asthma: The PRIME study","authors":"Guy Brusselle, Francesco Blasi, Christian Gessner, Piotr Kuna, Peter Wark, G. Cappellini, Emilie Oosterom, Marielle Van Der Deijl, Enrica Bucchioni, Eva Topole","doi":"10.1183/23120541.00174-2024","DOIUrl":"https://doi.org/10.1183/23120541.00174-2024","url":null,"abstract":"Inhaled corticosteroid/formoterol fumarate (ICS/FF) as-needed is recommended by the Global Initiative for Asthma as sole therapy in adults with mild asthma, with low-dose maintenance ICS plus short-acting β2-agonist (SABA) as an alternative. SABA alone is no longer recommended. Given these changes in recommendations, the observational PRIME study aimed to describe real-world treatment patterns in mild asthma in Europe.Adults with asthma receiving low-dose maintenance ICS, or as-needed ICS/FF or SABA were followed for 6 months. Data collected included Asthma Control Test (ACT), Asthma Control Questionnaire 5 item (ACQ-5), forced expiratory volume in 1 s (FEV1), and asthma exacerbations.The study was conducted in Germany, Italy, Poland and Spain, in 883 patients; 833 (94.3%) completed follow-up. At enrolment, 32.2% received maintenance ICS, 56.3% ICS/FF as-needed, and 11.6% SABA as-needed; 57.4%, 61.3%, and 54.9%, respectively, had well controlled asthma (ACQ-5/ACT definition). After 6 months, changes in mean FEV1were small in the maintenance ICS and ICS/FF as-needed groups, whereas there was a decline in FEV1in the SABA as-needed group. ACQ-5 total score improved from baseline in all three groups; 0.4%, 0.4% and 2.0% patients, respectively, had a severe exacerbation during the study.More patients received ICS/FF as-needed than SABA as-needed, suggesting that physicians are aware of the latest treatment recommendations. This real-world study provides additional support to the use of ICS/FF as-needed as preferred treatment for patients with mild asthma, whereas SABA as-needed was associated with a fall in lung function and more severe exacerbations.","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141019014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dupilumab-associated hypereosinophilia in severe asthma","authors":"April Strong, Tiffany Lin, Asger Sverrild, Anna Mackay, Joy Lee, Celia Zubrinich, Jonathan Pham, Julian Bosco, E. Denton, Monique Dols, Rob G. Stirling, Eli Dabscheck, Jhanavi Iyer, Andrew Gillman, M. Hew","doi":"10.1183/23120541.00048-2024","DOIUrl":"https://doi.org/10.1183/23120541.00048-2024","url":null,"abstract":"","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141019413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of time-of-day on the diagnostic performance of tests for asthma","authors":"Ran Wang, Steve Fowler, R. Maidstone, Laura Healy, S. Drake, Lesley Lowe, Angela Simpson, Clare S Murray, H. Durrington","doi":"10.1183/23120541.00916-2023","DOIUrl":"https://doi.org/10.1183/23120541.00916-2023","url":null,"abstract":"","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141020381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and initial validation of a disease-specific instrument to measure health-related quality of life in hypersensitivity pneumonitis","authors":"Kerri I. Aronson, M. Rajan, Janani Varadarajan, Tessy K. Paul, J. Swigris, Jamuna K Krishnan, R. Kaner, Fernando J. Martinez, M.M. Safford, Laura C. Pinheiro","doi":"10.1183/23120541.00155-2024","DOIUrl":"https://doi.org/10.1183/23120541.00155-2024","url":null,"abstract":"Disease-specific health-related quality of life (HRQOL) instruments enable us to capture domains that are most relevant to specific patient populations and are useful when a more individualized approach to patient assessment is desired. In this study, we assessed the validity and reliability of the first instrument specifically developed to measure HRQOL in Hypersensitivity Pneumonitis (HP).A 39-item HP-HRQOL instrument and several anchors were collected from a cohort of patients with HP. Exploratory factor analysis and item reduction were utilized to construct a shortened version of the instrument. Several validity and reliability analyses were conducted on this version of the HP-HRQOL.59 patients with HP completed the study. The revised HP-HRQOL instrument comprises 15 items composing 2 factors (domains): 1. Impacts on daily life; 2. Mental well-being. Internal consistency reliability was strong for factor 1 (Cronbach's alpha=0.94, 95% CI {0.92–0.96}) and factor 2 (Cronbach's alpha= 0.89, 95% CI {0.85–0.94}). Test re-test reliability was strong (ICC 0.94 95% CI {0.89–0.97}). The HP-HRQOL strongly correlated with other validated patient reported outcome measures and moderately correlated with %predicted forced vital capacity. The HP-HRQOL distinguished between those with different severities of HP as determined by lung function and supplemental oxygen use.The HP-HRQOL, the first patient reported outcome instrument specific to adults with HP, possesses strong validity and reliability characteristics for measuring disease-specific HRQOL and distinguishes among patients with different severities of disease.","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141022523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hybrid compared to conventional pulmonary rehabilitation: an equivalence analysis","authors":"M. Wuyts, I. Coosemans, S. Everaerts, A. Blondeel, S. Breuls, H. Demeyer, Wim Janssens, Thierry Troosters","doi":"10.1183/23120541.00984-2023","DOIUrl":"https://doi.org/10.1183/23120541.00984-2023","url":null,"abstract":"Pulmonary rehabilitation (PR) is a well-established intervention for patients with chronic obstructive pulmonary disease (COPD), but access, uptake and completion are low. This retrospective propensity-matched study aimed to analyse equivalence from a Hybrid PR modality against Conventional PR.Between 2013–2019, 214 patients with COPD with valid baseline physical activity assessments enrolled in Conventional PR for three times per week (3/wk) for three months. In 2021–2022, 44 patients with COPD enrolled in three months of Hybrid PR, introducing two providers: 1/wk in the outpatient centre and 2/wk in a primary care setting near the patient's home. All sessions were supervised. Propensity score matching (1:1) was performed. Equivalence between both programs was analysed for exercise capacity with the equivalence margins of -/+ 30 m. Clinical outcomes, accessibility and adherence were compared using t-tests.44 patients (age 67±8, FEV1%predicted 47±15, 6MWD 355±122 m) in the Hybrid PR group were matched to 44 patients (age 66±8, FEV1%predicted 46±17, 6MWD 354±103 m) in the Conventional PR group. Equivalence on the increase in 6MWD could not be confirmed, nevertheless both groups improved their 6MWD clinically significantly (Hybrid PR Δ63 CI[43–83]m; Conventional PR Δ39 CI[26–52]m). Changes in quality of life and symptoms were similar. Drop-out in Hybrid PR (23%) was comparable to Conventional PR (27%) (p=0.24). Adherence in both groups was high and accessibility was better for patients following Hybrid PR.Hybrid PR can be offered as an effective alternative to Conventional PR, if patients are willing to take up the offer.","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141022334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Does lung function mediate the role of environmental pollution on overall and cardiovascular disease mortality?","authors":"Guadalupe García, Lucía Martín-Gisbert, Cristina Candal-Pedreira, Alberto Ruano-Ravina","doi":"10.1183/23120541.00141-2024","DOIUrl":"https://doi.org/10.1183/23120541.00141-2024","url":null,"abstract":"<p><p><b>Lung function and its mediation role on environmental pollution and mortality</b> https://bit.ly/3pdVYJX.</p>","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11057502/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140854033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Air pollution, lung function and mortality: survival and mediation analyses in UK Biobank.","authors":"Anna L Guyatt, Yutong Samuel Cai, Dany Doiron, Martin D Tobin, Anna L Hansell","doi":"10.1183/23120541.00093-2024","DOIUrl":"https://doi.org/10.1183/23120541.00093-2024","url":null,"abstract":"<p><strong>Background: </strong>Air pollution is associated with lower lung function, and both are associated with premature mortality and cardiovascular disease (CVD). Evidence remains scarce on the potential mediating effect of impaired lung function on the association between air pollution and mortality or CVD.</p><p><strong>Methods: </strong>We used data from UK Biobank (n∼200 000 individuals) with 8-year follow-up to mortality and incident CVD. Exposures to particulate matter <10 µm (PM₁₀), particulate matter <2.5 µm (PM_2.5) and nitrogen dioxide (NO₂) were assessed by land-use regression modelling. Lung function (forced expiratory volume in 1 s (FEV₁), forced vital capacity (FVC) and the FEV₁/FVC ratio) was measured between 2006 and 2010 and transformed to Global Lung Function Initiative (GLI) z-scores. Adjusted Cox proportional hazards and causal proportional hazards mediation analysis models were fitted, stratified by smoking status.</p><p><strong>Results: </strong>Lower FEV₁ and FVC were associated with all-cause and CVD mortality, and incident CVD, with larger estimates in ever- than never-smokers (all-cause mortality hazard ratio per FEV₁ GLI z-score decrease 1.29 (95% CI 1.24-1.34) for ever-smokers and 1.16 (95% CI 1.12-1.21) for never-smokers). Long-term exposure to PM_2.5 or NO₂ was associated with incident CVD, with similar effect sizes for ever- and never-smokers. Mediated proportions of the air pollution-all-cause mortality estimates driven by FEV₁ were 18% (95% CI 2-33%) for PM_2.5 and 27% (95% CI 3-51%) for NO₂. Corresponding mediated proportions for incident CVD were 9% (95% CI 4-13%) for PM_2.5 and 16% (95% CI 6-25%) for NO₂.</p><p><strong>Conclusions: </strong>Lung function may mediate a modest proportion of associations between air pollution and mortality and CVD outcomes. Results likely reflect the extent of either shared mechanisms or direct effects relating to lower lung function caused by air pollution.</p>","PeriodicalId":11739,"journal":{"name":"ERJ Open Research","volume":null,"pages":null},"PeriodicalIF":4.6,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11057504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140861736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}