Pub Date : 2025-12-08DOI: 10.1186/s12890-025-04036-7
Julia von Rotz, Jan Mengers, Thomas Gaisl, Carolin Steinack, Didier Schneiter, Isabelle Opitz, Claudio Caviezel
Background: Lung volume reduction surgery (LVRS) enables a tailored resection of emphysematous lung areas, whereas bronchoscopic lung volume reduction (BLVR) with valves excludes a whole lobe. We hypothesize greater reduction of areas with low attenuation on computed tomography (CT) scans by LVRS, assuming to spare still functioning tissue, compared with BLVR.
Methods: LVRS patients were prospectively collected and a post-hoc analysis was performed to compare patients after BLVR with valves. Pre- and postoperative (3 months after LVRS, 1 months after BLVR) lung function, 6-minute walking distance (6-MWD) and changes in low attenuation areas (LAA, ≤- 950 hounsfield units) in CT was measured. The BLVR group needed proven target lobe atelectasis to be included. Primary endpoint was the radiologically measured LAA reduction.
Results: Among the 27 patients who underwent LVRS between August 2019 and October 2020, complete data were available for 19 patients. In contrast, 18 out of 27 BLVR patients achieved complete lobar atelectasis. Both LVRS and BLVR significantly improved LAA (Δ41% and Δ28%), lung function (forced expiratory volume in 1 second FEV1) and 6-MWD (all p<0.05). However, LVRS showed no significant advantage over BLVR for LAA (p=0.068), FEV1 (p=0.132) or 6-MWD (p=0.077).
Conclusion: Neither LVRS nor BLVR seem to be superior in sparing or eliminating still functional tissue, as both methods showed no differences in reduction of LAA. This information might contribute to the decision at an interdisciplinary emphysema board, where all cases are preferably discussed.
{"title":"Reduction of low attenuation areas of emphysema after lung volume reduction surgery compared to bronchoscopic lung volume reduction with valves.","authors":"Julia von Rotz, Jan Mengers, Thomas Gaisl, Carolin Steinack, Didier Schneiter, Isabelle Opitz, Claudio Caviezel","doi":"10.1186/s12890-025-04036-7","DOIUrl":"10.1186/s12890-025-04036-7","url":null,"abstract":"<p><strong>Background: </strong>Lung volume reduction surgery (LVRS) enables a tailored resection of emphysematous lung areas, whereas bronchoscopic lung volume reduction (BLVR) with valves excludes a whole lobe. We hypothesize greater reduction of areas with low attenuation on computed tomography (CT) scans by LVRS, assuming to spare still functioning tissue, compared with BLVR.</p><p><strong>Methods: </strong>LVRS patients were prospectively collected and a post-hoc analysis was performed to compare patients after BLVR with valves. Pre- and postoperative (3 months after LVRS, 1 months after BLVR) lung function, 6-minute walking distance (6-MWD) and changes in low attenuation areas (LAA, ≤- 950 hounsfield units) in CT was measured. The BLVR group needed proven target lobe atelectasis to be included. Primary endpoint was the radiologically measured LAA reduction.</p><p><strong>Results: </strong>Among the 27 patients who underwent LVRS between August 2019 and October 2020, complete data were available for 19 patients. In contrast, 18 out of 27 BLVR patients achieved complete lobar atelectasis. Both LVRS and BLVR significantly improved LAA (Δ41% and Δ28%), lung function (forced expiratory volume in 1 second FEV1) and 6-MWD (all p<0.05). However, LVRS showed no significant advantage over BLVR for LAA (p=0.068), FEV1 (p=0.132) or 6-MWD (p=0.077).</p><p><strong>Conclusion: </strong>Neither LVRS nor BLVR seem to be superior in sparing or eliminating still functional tissue, as both methods showed no differences in reduction of LAA. This information might contribute to the decision at an interdisciplinary emphysema board, where all cases are preferably discussed.</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":"25 1","pages":"555"},"PeriodicalIF":2.8,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12683783/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145706994","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}
Pub Date : 2025-12-08DOI: 10.1186/s12890-025-04051-8
Mengistu Abayneh, Ahmed Zeynudin, Yared Alemu, Teshome Degefa, Abdulhakim Abamecha, Mulualem Tadesse, Abraham Tamirat Gizaw
Background: The spread of tuberculosis (TB), including strains resistant to at least rifampicin and/or isoniazid, remains a major public health problem in developing nations, yet few comprehensive and comparative data on TB have been produced. The aim of this systematic review and meta-analysis is to determine the pooled prevalence of TB in general and rifampicin-resistant tuberculosis (RR-TB) among presumptive TB patients across different demographic groups in Ethiopia. A presumptive TB patient is someone who shows symptoms or risk factors suggestive of tuberculosis and therefore requires testing.
Methods: For this systematic reviews and meta-analysis PubMed, and Google Scholar databases were searched. In addition, relevant studies were also searched from the bibliographies of eligible studies and from other meta-analysis studies. A selection and inclusion-exclusion process for the required articles was made as per the study objectives and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines and the Joanna Briggs Institute's (JBI) essential appraisal tools were followed during the entire protocol development. The pooled prevalence of TB in general and RR-TB among different demographic categories was estimated with a random-effects model on Statistical Software Package (STATA) version 14.0.
Results: A total of 39 research articles fulfilled the inclusion criteria for this systematic review and meta-analysis. The overall pooled prevalence estimates of TB in general and RR-TB were 15% (95% CI; 0.13-0.17) and 8% (95% CI; 0.07-0.10), respectively. The pooled prevalence of each pulmonary TB and extrapulmonary TB cases was equally 15%, and the pooled prevalence of RR-TB was 8% and 9%, respectively. The pooled prevalence of TB among male and female was 15%, and 13%, whereas RR-TB was detected in 10% and 9% of the TB cases, respectively. Among adults and children, the pooled prevalence of TB was 15% and 13%, whereas RR-TB was detected in 9% and 8% of the TB cases, respectively. The pooled prevalence of TB among newly diagnosed and previous treated TB cases was 13% and 22%, whereas RR-TB was 7% and 17%, respectively. Among HIV-positive cases, the pooled prevalence of TB was 20%, whereas the RR-TB was detected in 13% of TB-HIV cases.
Conclusion: This meta-analysis report concluded that the pooled prevalence of TB in general and RR-TB was high across various demographic categories in Ethiopia. Hence, the finding highlights the need to implement integrated intervention approaches such as early case detection, rapid diagnosis, treatment adherence support, and contact tracing to reduce the continued spreading of TB infections, with an emphasis on reducing the spread of drug- resistant TB strains.
{"title":"The prevalence of Mycobacterium tuberculosis and rifampicin-resistance strains using GeneXpert-MTB/RIF assay in Ethiopia: a systematic review and meta-analysis.","authors":"Mengistu Abayneh, Ahmed Zeynudin, Yared Alemu, Teshome Degefa, Abdulhakim Abamecha, Mulualem Tadesse, Abraham Tamirat Gizaw","doi":"10.1186/s12890-025-04051-8","DOIUrl":"10.1186/s12890-025-04051-8","url":null,"abstract":"<p><strong>Background: </strong>The spread of tuberculosis (TB), including strains resistant to at least rifampicin and/or isoniazid, remains a major public health problem in developing nations, yet few comprehensive and comparative data on TB have been produced. The aim of this systematic review and meta-analysis is to determine the pooled prevalence of TB in general and rifampicin-resistant tuberculosis (RR-TB) among presumptive TB patients across different demographic groups in Ethiopia. A presumptive TB patient is someone who shows symptoms or risk factors suggestive of tuberculosis and therefore requires testing.</p><p><strong>Methods: </strong>For this systematic reviews and meta-analysis PubMed, and Google Scholar databases were searched. In addition, relevant studies were also searched from the bibliographies of eligible studies and from other meta-analysis studies. A selection and inclusion-exclusion process for the required articles was made as per the study objectives and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines and the Joanna Briggs Institute's (JBI) essential appraisal tools were followed during the entire protocol development. The pooled prevalence of TB in general and RR-TB among different demographic categories was estimated with a random-effects model on Statistical Software Package (STATA) version 14.0.</p><p><strong>Results: </strong>A total of 39 research articles fulfilled the inclusion criteria for this systematic review and meta-analysis. The overall pooled prevalence estimates of TB in general and RR-TB were 15% (95% CI; 0.13-0.17) and 8% (95% CI; 0.07-0.10), respectively. The pooled prevalence of each pulmonary TB and extrapulmonary TB cases was equally 15%, and the pooled prevalence of RR-TB was 8% and 9%, respectively. The pooled prevalence of TB among male and female was 15%, and 13%, whereas RR-TB was detected in 10% and 9% of the TB cases, respectively. Among adults and children, the pooled prevalence of TB was 15% and 13%, whereas RR-TB was detected in 9% and 8% of the TB cases, respectively. The pooled prevalence of TB among newly diagnosed and previous treated TB cases was 13% and 22%, whereas RR-TB was 7% and 17%, respectively. Among HIV-positive cases, the pooled prevalence of TB was 20%, whereas the RR-TB was detected in 13% of TB-HIV cases.</p><p><strong>Conclusion: </strong>This meta-analysis report concluded that the pooled prevalence of TB in general and RR-TB was high across various demographic categories in Ethiopia. Hence, the finding highlights the need to implement integrated intervention approaches such as early case detection, rapid diagnosis, treatment adherence support, and contact tracing to reduce the continued spreading of TB infections, with an emphasis on reducing the spread of drug- resistant TB strains.</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":" ","pages":"11"},"PeriodicalIF":2.8,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12801861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145707023","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}
Pub Date : 2025-12-05DOI: 10.1186/s12890-025-04027-8
Jiaqi Ren, Ying Luo, Lina Sun, Chun Chang, Yongchang Sun
Background: Allergic bronchopulmonary aspergillosis (ABPA) is a complex hypersensitivity disorder caused by Aspergillus sensitization, mostly associated with asthma, but occasionally seen in patients with chronic obstructive pulmonary disease (COPD). This study aimed to analyze the clinical features, treatment responses, and long-term follow-up of patients with ABPA-COPD overlap syndrome.
Methods: we identified 6 cases of ABPA with underlying COPD from a cohort of ABPA in our hospital. We described symptoms, imaging findings, serology tests, pulmonary functions and treatment outcomes of these cases.
Results: From January 1st, 2013 to December 31th, 2024, 63 cases of ABPA were diagnosed in our hospital, of them 6 (9.52%) were found to have underlying COPD. The 6 patients were all male, aging from 63 to 89 years, with 5 having a smoking history. The presenting symptoms included persistent cough, sputum and exertional dyspnea. The blood total IgE was markedly elevated (1230-2951 KU/L), and all tested positive for A. fumigatus-specific IgE. Blood eosinophil count was 90-1610 cells/µl. CT revealed bronchiectasis (predominantly lower lobes) and emphysema in all cases. Four patients responded well to oral corticosteroids, while 2 required omalizumab for disease control. After follow-up for 1-4 years, 4 patients remained stable, 1 had recurrent exacerbations, and 1 died due to multi-organ failure.
Conclusions: ABPA should be considered in COPD patients with persistent or recurrent respiratory symptoms, higher blood eosinophils, particularly those with bronchiectasis on chest CT. ABPA represents a treatable trait in COPD patients. While corticosteroids remain the first-line therapy, treatment-resistant cases may benefit from biologic agents.
{"title":"Allergic bronchopulmonary aspergillosis in patients with chronic obstructive pulmonary disease: a case series and literature review.","authors":"Jiaqi Ren, Ying Luo, Lina Sun, Chun Chang, Yongchang Sun","doi":"10.1186/s12890-025-04027-8","DOIUrl":"10.1186/s12890-025-04027-8","url":null,"abstract":"<p><strong>Background: </strong>Allergic bronchopulmonary aspergillosis (ABPA) is a complex hypersensitivity disorder caused by Aspergillus sensitization, mostly associated with asthma, but occasionally seen in patients with chronic obstructive pulmonary disease (COPD). This study aimed to analyze the clinical features, treatment responses, and long-term follow-up of patients with ABPA-COPD overlap syndrome.</p><p><strong>Methods: </strong>we identified 6 cases of ABPA with underlying COPD from a cohort of ABPA in our hospital. We described symptoms, imaging findings, serology tests, pulmonary functions and treatment outcomes of these cases.</p><p><strong>Results: </strong>From January 1st, 2013 to December 31th, 2024, 63 cases of ABPA were diagnosed in our hospital, of them 6 (9.52%) were found to have underlying COPD. The 6 patients were all male, aging from 63 to 89 years, with 5 having a smoking history. The presenting symptoms included persistent cough, sputum and exertional dyspnea. The blood total IgE was markedly elevated (1230-2951 KU/L), and all tested positive for A. fumigatus-specific IgE. Blood eosinophil count was 90-1610 cells/µl. CT revealed bronchiectasis (predominantly lower lobes) and emphysema in all cases. Four patients responded well to oral corticosteroids, while 2 required omalizumab for disease control. After follow-up for 1-4 years, 4 patients remained stable, 1 had recurrent exacerbations, and 1 died due to multi-organ failure.</p><p><strong>Conclusions: </strong>ABPA should be considered in COPD patients with persistent or recurrent respiratory symptoms, higher blood eosinophils, particularly those with bronchiectasis on chest CT. ABPA represents a treatable trait in COPD patients. While corticosteroids remain the first-line therapy, treatment-resistant cases may benefit from biologic agents.</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":"25 1","pages":"554"},"PeriodicalIF":2.8,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12681173/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145686982","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}
Introduction: Data on risk factors for discontinuation of nintedanib in patients with interstitial lung diseases (ILDs) are limited. The differences in tolerability between patients with idiopathic pulmonary fibrosis (IPF) and those with progressive fibrotic interstitial lung diseases (PF-ILDs), as well as between different severities, remain unclear. The aim of this study was to investigate the clinical characteristics associated with discontinuation of nintedanib, including severity and the presence of IPF or PF-ILDs, in patients with ILDs.
Methods: A multicenter, retrospective study was conducted. Patients with IPF and PF-ILDs who had been treated with nintedanib from August 2015 to December 2023 were analyzed. Severity at baseline was assessed using the gender-age-physiology (GAP) model. Clinical characteristics were compared between the nintedanib discontinuation within 12 months group and the nintedanib continuation over 12 months group.
Results: A total of 212 ILD patients were included in the analysis, of whom 165 (77.8%) had IPF, and 47 (22.2%) had PF-ILDs. Fifty-five (25.9%) patients discontinued nintedanib within 12 months. The risk of nintedanib discontinuation was associated with higher GAP stage, lower body mass index (BMI), and no dose reduction. Patients with a higher GAP stage and lower BMI also had poor overall survival. There were no significant differences between IPF and PF-ILDs in both nintedanib discontinuation and mortality.
Conclusions: GAP stage and BMI can be useful for predicting prognosis and future nintedanib discontinuation in patients with IPF and PF-ILDs. Nintedanib treatment may be considered in patients with IPF and PF-ILDs in an earlier stage of the disease.
{"title":"Gender-age-physiology stage and body mass index are useful predictors of nintedanib discontinuation and prognosis in patients with idiopathic pulmonary fibrosis and progressive fibrotic interstitial lung diseases.","authors":"Kai Yazaki, Masashi Matsuyama, Hiroaki Satoh, Kunihiko Miyazaki, Naoki Arai, Yukio Ishii, Takeo Endo, Takayuki Kaburagi, Takeshi Kawakami, Hiroaki Iijima, Toshiaki Motegi, Shigen Hayashi, Norihiro Kikuchi, Tohru Sakamoto, Nobuyuki Hizawa","doi":"10.1186/s12890-025-04048-3","DOIUrl":"10.1186/s12890-025-04048-3","url":null,"abstract":"<p><strong>Introduction: </strong>Data on risk factors for discontinuation of nintedanib in patients with interstitial lung diseases (ILDs) are limited. The differences in tolerability between patients with idiopathic pulmonary fibrosis (IPF) and those with progressive fibrotic interstitial lung diseases (PF-ILDs), as well as between different severities, remain unclear. The aim of this study was to investigate the clinical characteristics associated with discontinuation of nintedanib, including severity and the presence of IPF or PF-ILDs, in patients with ILDs.</p><p><strong>Methods: </strong>A multicenter, retrospective study was conducted. Patients with IPF and PF-ILDs who had been treated with nintedanib from August 2015 to December 2023 were analyzed. Severity at baseline was assessed using the gender-age-physiology (GAP) model. Clinical characteristics were compared between the nintedanib discontinuation within 12 months group and the nintedanib continuation over 12 months group.</p><p><strong>Results: </strong>A total of 212 ILD patients were included in the analysis, of whom 165 (77.8%) had IPF, and 47 (22.2%) had PF-ILDs. Fifty-five (25.9%) patients discontinued nintedanib within 12 months. The risk of nintedanib discontinuation was associated with higher GAP stage, lower body mass index (BMI), and no dose reduction. Patients with a higher GAP stage and lower BMI also had poor overall survival. There were no significant differences between IPF and PF-ILDs in both nintedanib discontinuation and mortality.</p><p><strong>Conclusions: </strong>GAP stage and BMI can be useful for predicting prognosis and future nintedanib discontinuation in patients with IPF and PF-ILDs. Nintedanib treatment may be considered in patients with IPF and PF-ILDs in an earlier stage of the disease.</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":" ","pages":"564"},"PeriodicalIF":2.8,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12751843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145686951","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}
Pub Date : 2025-12-04DOI: 10.1186/s12890-025-03973-7
Wim A Wuyts, Luca Richeldi, Shervin Assassi, Arata Azuma, Vincent Cottin, Anna-Maria Hoffmann-Vold, Michael Kreuter, Justin M Oldham, Fernando J Martinez, Claudia Valenzuela, Marlies S Wijsenbeek, Madhu Kanakapura, Alexandra James, Gerrit Weimann, Cyril Drzewuski, Carl Coeck, Toby M Maher
Background: There is a need for more effective treatments for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Nerandomilast (BI 1015550), an oral preferential inhibitor of phosphodiesterase 4B, is being evaluated in two randomized Phase III trials: FIBRONEER™-IPF (NCT05321069) and FIBRONEER™-ILD (NCT05321082). FIBRONEER™-ON is an open-label extension (OLE) of these studies that will evaluate the long-term safety and efficacy of nerandomilast. Here, we describe the study design of the OLE.
Methods: This prospective 98-week OLE will follow the Phase III parent trials, which are currently underway with 1177 patients enrolled in FIBRONEER™-IPF and 1178 patients enrolled in FIBRONEER™-ILD. Approximately 1700 patients from 44 countries are expected to complete the parent trials and will be eligible for continuing into the OLE; this estimate assumes that there will be a discontinuation rate of ~25% over the duration of the parent trials and > 90% of eligible patients will agree to participate in the OLE. Irrespective of whether previously on active treatment or placebo, all patients in the OLE will be treated with nerandomilast at either 9 mg or 18 mg twice daily, depending on which dose demonstrates the most favorable benefit-risk profile in the parent trials. The primary endpoint will be the occurrence of any adverse event over the course of the OLE. This trial will also monitor long-term efficacy outcomes, including forced vital capacity change, and time to first exacerbation, disease progression, hospitalization and death.
Discussion: This trial will provide information on the long-term safety, tolerability and efficacy of nerandomilast in patients with IPF and PPF.
Trial registration: FIBRONEER™-ON: ClinicalTrials.gov: NCT06238622, registered 2 February 2024. Protocol version and date: version 3.0, 29 Apr 2024. FIBRONEER™-IPF: ClinicalTrials.gov: NCT05321069, registered 11 March 2022.FIBRONEER™-ILD: ClinicalTrials.gov: NCT05321082, registered 11 March 2022.
{"title":"Design of an open-label extension trial of nerandomilast (BI 1015550) in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (FIBRONEER™-ON).","authors":"Wim A Wuyts, Luca Richeldi, Shervin Assassi, Arata Azuma, Vincent Cottin, Anna-Maria Hoffmann-Vold, Michael Kreuter, Justin M Oldham, Fernando J Martinez, Claudia Valenzuela, Marlies S Wijsenbeek, Madhu Kanakapura, Alexandra James, Gerrit Weimann, Cyril Drzewuski, Carl Coeck, Toby M Maher","doi":"10.1186/s12890-025-03973-7","DOIUrl":"10.1186/s12890-025-03973-7","url":null,"abstract":"<p><strong>Background: </strong>There is a need for more effective treatments for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Nerandomilast (BI 1015550), an oral preferential inhibitor of phosphodiesterase 4B, is being evaluated in two randomized Phase III trials: FIBRONEER™-IPF (NCT05321069) and FIBRONEER™-ILD (NCT05321082). FIBRONEER™-ON is an open-label extension (OLE) of these studies that will evaluate the long-term safety and efficacy of nerandomilast. Here, we describe the study design of the OLE.</p><p><strong>Methods: </strong>This prospective 98-week OLE will follow the Phase III parent trials, which are currently underway with 1177 patients enrolled in FIBRONEER™-IPF and 1178 patients enrolled in FIBRONEER™-ILD. Approximately 1700 patients from 44 countries are expected to complete the parent trials and will be eligible for continuing into the OLE; this estimate assumes that there will be a discontinuation rate of ~25% over the duration of the parent trials and > 90% of eligible patients will agree to participate in the OLE. Irrespective of whether previously on active treatment or placebo, all patients in the OLE will be treated with nerandomilast at either 9 mg or 18 mg twice daily, depending on which dose demonstrates the most favorable benefit-risk profile in the parent trials. The primary endpoint will be the occurrence of any adverse event over the course of the OLE. This trial will also monitor long-term efficacy outcomes, including forced vital capacity change, and time to first exacerbation, disease progression, hospitalization and death.</p><p><strong>Discussion: </strong>This trial will provide information on the long-term safety, tolerability and efficacy of nerandomilast in patients with IPF and PPF.</p><p><strong>Trial registration: </strong>FIBRONEER™-ON: ClinicalTrials.gov: NCT06238622, registered 2 February 2024. Protocol version and date: version 3.0, 29 Apr 2024. FIBRONEER™-IPF: ClinicalTrials.gov: NCT05321069, registered 11 March 2022.FIBRONEER™-ILD: ClinicalTrials.gov: NCT05321082, registered 11 March 2022.</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":" ","pages":"10"},"PeriodicalIF":2.8,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12797674/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145676516","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}
Pub Date : 2025-12-03DOI: 10.1186/s12890-025-03952-y
Pradeesh Sivapalan, Valdemar Rømer, Alexander Jordan, Niklas Dyrby Johansen, Manan Pareek, Daniel Modin, Alexander G Mathioudakis, Jørgen Vestbo, Anna Kubel Vognsen, Josefin Eklöf, John R Hurst, Tobias Wirenfeldt Klausen, Tor Biering-Sørensen, Jens-Ulrik Staehr Jensen
Background: Night-time parasympathetic activation, diminished effect of long-acting muscarinic antagonists (LAMA) closer to end of the dosing period, and frequent exacerbations in chronic obstructive pulmonary disease (COPD) during night suggests greater benefits of evening administration of once-daily LAMA.
Methods: We electronically invited 172,852 Danish COPD patients who used once-daily LAMA (including dual/triple therapy) to participate in a randomized controlled, digital platform, pragmatic trial comparing evening with morning LAMA administration. Of these, 10,011 patients consented and were randomized. National health registries were the main source for follow-up data. The primary endpoint was a composite of COPD exacerbations requiring hospitalization or all-cause death within one year. Secondary endpoints were moderate COPD exacerbations, all-cause hospitalization, intensive-care admission, non-invasive ventilation, all-cause mortality, and consumption of short-acting beta-2-agonists.
Results: A total of 10,011 COPD patients were randomized to evening (n=4,983) or morning (n=5,028) LAMA administration. We had complete (100%) follow-up on the primary and secondary outcomes. In the evening-LAMA group, 245 persons (5%) met the primary outcome compared with 249 persons (5%) in the morning-LAMA group (P=0.93). There were 61 (1%) intensive-care admissions in the evening-LAMA group versus 95 (2%) in the morning-LAMA group (P=0.046). Other secondary outcomes were neutral. Administration-time adherence was low in the evening-LAMA group being 73% at 6 months and 66% at 12 months among survey responders (65% and 63%, respectively).
Conclusions: Evening administration of LAMA did not reduce the incidence of COPD exacerbations requiring hospitalization or all-cause death. Poor adherence may have contributed to the negative study outcome. The trial serves as a proof-of-concept for decentralized digital trials.
{"title":"Evening administration of long-acting muscarinic antagonists in COPD - a randomized controlled trial.","authors":"Pradeesh Sivapalan, Valdemar Rømer, Alexander Jordan, Niklas Dyrby Johansen, Manan Pareek, Daniel Modin, Alexander G Mathioudakis, Jørgen Vestbo, Anna Kubel Vognsen, Josefin Eklöf, John R Hurst, Tobias Wirenfeldt Klausen, Tor Biering-Sørensen, Jens-Ulrik Staehr Jensen","doi":"10.1186/s12890-025-03952-y","DOIUrl":"10.1186/s12890-025-03952-y","url":null,"abstract":"<p><strong>Background: </strong>Night-time parasympathetic activation, diminished effect of long-acting muscarinic antagonists (LAMA) closer to end of the dosing period, and frequent exacerbations in chronic obstructive pulmonary disease (COPD) during night suggests greater benefits of evening administration of once-daily LAMA.</p><p><strong>Methods: </strong>We electronically invited 172,852 Danish COPD patients who used once-daily LAMA (including dual/triple therapy) to participate in a randomized controlled, digital platform, pragmatic trial comparing evening with morning LAMA administration. Of these, 10,011 patients consented and were randomized. National health registries were the main source for follow-up data. The primary endpoint was a composite of COPD exacerbations requiring hospitalization or all-cause death within one year. Secondary endpoints were moderate COPD exacerbations, all-cause hospitalization, intensive-care admission, non-invasive ventilation, all-cause mortality, and consumption of short-acting beta-2-agonists.</p><p><strong>Results: </strong>A total of 10,011 COPD patients were randomized to evening (n=4,983) or morning (n=5,028) LAMA administration. We had complete (100%) follow-up on the primary and secondary outcomes. In the evening-LAMA group, 245 persons (5%) met the primary outcome compared with 249 persons (5%) in the morning-LAMA group (P=0.93). There were 61 (1%) intensive-care admissions in the evening-LAMA group versus 95 (2%) in the morning-LAMA group (P=0.046). Other secondary outcomes were neutral. Administration-time adherence was low in the evening-LAMA group being 73% at 6 months and 66% at 12 months among survey responders (65% and 63%, respectively).</p><p><strong>Conclusions: </strong>Evening administration of LAMA did not reduce the incidence of COPD exacerbations requiring hospitalization or all-cause death. Poor adherence may have contributed to the negative study outcome. The trial serves as a proof-of-concept for decentralized digital trials.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov: NCT05563675, registered 28/09/2022 https://clinicaltrials.gov/study/NCT0556367 .</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":"25 1","pages":"552"},"PeriodicalIF":2.8,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12676790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145667052","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}
Pub Date : 2025-12-01DOI: 10.1186/s12890-025-04011-2
Jiyoung Yoon, Jai Hoon Yoon, Heajung Lee, Jun Su Lee, Seong Mi Moon, Hayoung Choi, Bumhee Yang, Hyun Lee
Introduction: A close association between gastroesophageal reflux disease (GERD) and chronic respiratory diseases has been suggested. However, limited information is available on whether GERD is associated with an increased incidence of bronchiectasis.
Methods: Using a nationwide representative claims database, we identified adults with GERD (GERD cohort) and propensity score-matched controls without GERD (matched controls) between 2004 and 2012. Both cohorts were followed until the date of bronchiectasis diagnosis, date of death, or December 31, 2015. Cox proportional hazard regression analyses were used to evaluate the risk of bronchiectasis between groups. Using the GERD cohort, we also evaluated factors associated with bronchiectasis.
Results: During the median follow-up of 9.5 years (interquartile range: 6.33-12.17 years), the cumulative incidence of bronchiectasis was significantly higher in the GERD cohort than in matched controls (418.59 person-years vs. 291.68 person-years; P < 0.01), with a hazard ratio (HR) of 1.43 (95% confidence interval [CI] = 1.13-1.55). Besides, the risk of bronchiectasis increased as GERD severity increased (HR = 1.24, 95% CI = 1.12-1.38 for mild GERD group and HR = 1.48, 95% CI = 1.35-1.62 for severe GERD group). Among the GERD cohort, factors associated with increased risk bronchiectasis were older age (the highest adjusted hazard ratio [aHR] = 8.46, 95% CI = 4.84-14.80 for individuals aged 70 years or older versus individuals aged 20-29), underweight (aHR = 1.79, 95% CI = 1.35-2.37), chronic obstructive pulmonary disease (aHR = 1.33, 95% CI = 1.06-1.67), asthma (aHR = 1.51, 95% CI = 1.25-1.82), and peptic ulcer disease (aHR = 1.26, 95% CI = 1.09-1.46).
Conclusion: GERD is associated with an increased risk of bronchiectasis. Older age, underweight, coexisting airway diseases, and peptic ulcer disease were risk factors for developing bronchiectasis in GERD.
{"title":"Association between gastroesophageal reflux disease and incident bronchiectasis: a nationwide representative population-based study in Korea.","authors":"Jiyoung Yoon, Jai Hoon Yoon, Heajung Lee, Jun Su Lee, Seong Mi Moon, Hayoung Choi, Bumhee Yang, Hyun Lee","doi":"10.1186/s12890-025-04011-2","DOIUrl":"10.1186/s12890-025-04011-2","url":null,"abstract":"<p><strong>Introduction: </strong>A close association between gastroesophageal reflux disease (GERD) and chronic respiratory diseases has been suggested. However, limited information is available on whether GERD is associated with an increased incidence of bronchiectasis.</p><p><strong>Methods: </strong>Using a nationwide representative claims database, we identified adults with GERD (GERD cohort) and propensity score-matched controls without GERD (matched controls) between 2004 and 2012. Both cohorts were followed until the date of bronchiectasis diagnosis, date of death, or December 31, 2015. Cox proportional hazard regression analyses were used to evaluate the risk of bronchiectasis between groups. Using the GERD cohort, we also evaluated factors associated with bronchiectasis.</p><p><strong>Results: </strong>During the median follow-up of 9.5 years (interquartile range: 6.33-12.17 years), the cumulative incidence of bronchiectasis was significantly higher in the GERD cohort than in matched controls (418.59 person-years vs. 291.68 person-years; P < 0.01), with a hazard ratio (HR) of 1.43 (95% confidence interval [CI] = 1.13-1.55). Besides, the risk of bronchiectasis increased as GERD severity increased (HR = 1.24, 95% CI = 1.12-1.38 for mild GERD group and HR = 1.48, 95% CI = 1.35-1.62 for severe GERD group). Among the GERD cohort, factors associated with increased risk bronchiectasis were older age (the highest adjusted hazard ratio [aHR] = 8.46, 95% CI = 4.84-14.80 for individuals aged 70 years or older versus individuals aged 20-29), underweight (aHR = 1.79, 95% CI = 1.35-2.37), chronic obstructive pulmonary disease (aHR = 1.33, 95% CI = 1.06-1.67), asthma (aHR = 1.51, 95% CI = 1.25-1.82), and peptic ulcer disease (aHR = 1.26, 95% CI = 1.09-1.46).</p><p><strong>Conclusion: </strong>GERD is associated with an increased risk of bronchiectasis. Older age, underweight, coexisting airway diseases, and peptic ulcer disease were risk factors for developing bronchiectasis in GERD.</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":" ","pages":"7"},"PeriodicalIF":2.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12771859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145652924","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}
Pub Date : 2025-12-01DOI: 10.1186/s12890-025-03987-1
Kjell Torén, Nicola Murgia, Maria Åberg, Martin Andersson, Bengt Järvholm
Background: The aim was to elucidate whether occupational airborne exposures increases asthma mortality.
Methods: The study comprised men in the Swedish construction industry who participated in health controls in 1971-1993. Exposure was assessed using a job-exposure matrix with focus on exposures in the mid-1970s. Mortality from asthma in 1987-2015 was compared between 147,101 workers exposed to occupational airborne exposures and 26,879 foremen, using underlying and contributory cause of death from the Swedish Cause of Death Register. Mortality was assessed as relative risk with 95% confidence intervals using Poisson regression models adjusting for age, smoking, body mass index, and calendar time.
Results: Among exposed workers, there were 82 deaths with asthma as the underlying cause and 212 deaths with asthma as the contributory cause vs. ten and 21 deaths in the controls. The asthma mortality based on the underlying and contributory cause was 1.92 (1.31-2.83) in relation to inorganic dust, 2.17 (1.47-3.20) in relation to fumes, 1.60 (1.04-2.47) in relation to gases, and 1.79 (1.09-2.96) in relation to wood dust. Using only the underlying cause of death showed similar mortality estimates, but with wider confidence intervals including unity.
Conclusions: Occupational airborne exposures increased the asthma mortality, underscoring the need for further reduction of the airborne occupational exposures. Workers with asthma should be given information about the effects of exposure and support to decrease exposure. The study shows the importance of using both contributing and underlying cause of death in studies assessing asthma mortality risk in relation to air pollutants.
{"title":"Occupational airborne exposures and asthma mortality - examining asthma as the underlying and contributing cause of death.","authors":"Kjell Torén, Nicola Murgia, Maria Åberg, Martin Andersson, Bengt Järvholm","doi":"10.1186/s12890-025-03987-1","DOIUrl":"10.1186/s12890-025-03987-1","url":null,"abstract":"<p><strong>Background: </strong>The aim was to elucidate whether occupational airborne exposures increases asthma mortality.</p><p><strong>Methods: </strong>The study comprised men in the Swedish construction industry who participated in health controls in 1971-1993. Exposure was assessed using a job-exposure matrix with focus on exposures in the mid-1970s. Mortality from asthma in 1987-2015 was compared between 147,101 workers exposed to occupational airborne exposures and 26,879 foremen, using underlying and contributory cause of death from the Swedish Cause of Death Register. Mortality was assessed as relative risk with 95% confidence intervals using Poisson regression models adjusting for age, smoking, body mass index, and calendar time.</p><p><strong>Results: </strong>Among exposed workers, there were 82 deaths with asthma as the underlying cause and 212 deaths with asthma as the contributory cause vs. ten and 21 deaths in the controls. The asthma mortality based on the underlying and contributory cause was 1.92 (1.31-2.83) in relation to inorganic dust, 2.17 (1.47-3.20) in relation to fumes, 1.60 (1.04-2.47) in relation to gases, and 1.79 (1.09-2.96) in relation to wood dust. Using only the underlying cause of death showed similar mortality estimates, but with wider confidence intervals including unity.</p><p><strong>Conclusions: </strong>Occupational airborne exposures increased the asthma mortality, underscoring the need for further reduction of the airborne occupational exposures. Workers with asthma should be given information about the effects of exposure and support to decrease exposure. The study shows the importance of using both contributing and underlying cause of death in studies assessing asthma mortality risk in relation to air pollutants.</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":"25 1","pages":"551"},"PeriodicalIF":2.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12667042/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145652968","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}
Background: Computed tomography (CT)-based quantification of coronavirus disease 2019 (COVID-19) pneumonia is widely performed, and total pneumonia volume, ground-glass opacity (GGO), and consolidation affect disease severity. However, there is insufficient information on how consolidation to GGO (C/G) ratio correlates with clinical characteristics including disease severity and complications in COVID-19 patients.
Methods: This retrospective cohort study included 1,194 hospitalized patients with COVID-19 from four member hospitals of the Japan COVID-19 Task Force. Critical outcomes were defined as conditions requiring high-flow oxygen or invasive mechanical ventilation, or death. Patients were divided into two groups based on %pneumonia (percentage of pneumonia volume divided by total lung volume) using receiver operating characteristic curve, and those with high %pneumonia were further divided into two groups based on C/G ratio. Critical outcomes and complications were then compared between high and low C/G ratio groups.
Results: The optimal cutoff value of %pneumonia to predict critical outcomes was 17.1%, classifying the included patients into low (Group 1, n = 900) and high (n = 294) %pneumonia groups. The optimal cutoff value of C/G ratio was 0.202, classifying patients in the high %pneumonia group into two groups: low (Group 2, n = 192) and high C/G (Group 3, n = 102) ratio groups. The incidence of critical outcomes was stair-step high in all three groups (2.1%, 21.4%, and 37.3%, respectively). Multivariable analysis revealed an independent relationship between C/G ratio and critical outcomes from other known risk factors (adjusted odds ratio: 1.92, 95% confidential interval: 1.03-3.59, P = 0.040). Group 3 also showed significantly higher serum C-reactive protein (Group 1: 2.96 mg/dL, Group 2: 8.90 mg/dL, Group 3: 11.4 mg/dL) and procalcitonin (Group 1: 0.16 ng/mL, Group 2: 0.25 ng/mL, Group 3: 1.19 ng/mL) levels and incidence of bacterial infection (Group 1: 5.6%, Group 2: 10.4%, Group 3: 20.3%), compared with other groups.
Conclusions: CT-density analysis of COVID-19 pneumonia in a large patient population showed that C/G ratio was a significant predictor of critical outcomes and useful for prognosis evaluation.
{"title":"Consolidation-to-ground-glass opacity ratio on chest CT as a prognostic marker for critical outcomes in COVID-19: a retrospective cohort study.","authors":"Hiromu Tanaka, Naoya Tanabe, Shotaro Chubachi, Tomoki Maetani, Yusuke Shiraishi, Ho Namkoong, Takanori Asakura, Takashi Shimada, Shuhei Azekawa, Shiro Otake, Kensuke Nakagawara, Takahiro Fukushima, Mayuko Watase, Hideki Terai, Mamoru Sasaki, Soichiro Ueda, Yukari Kato, Norihiro Harada, Shoji Suzuki, Shuichi Yoshida, Hiroki Tateno, Yoshitake Yamada, Masahiro Jinzaki, Toyohiro Hirai, Yukinori Okada, Ryuji Koike, Makoto Ishii, Naoki Hasegawa, Akinori Kimura, Seiya Imoto, Satoru Miyano, Seishi Ogawa, Takanori Kanai, Koichi Fukunaga","doi":"10.1186/s12890-025-04030-z","DOIUrl":"10.1186/s12890-025-04030-z","url":null,"abstract":"<p><strong>Background: </strong>Computed tomography (CT)-based quantification of coronavirus disease 2019 (COVID-19) pneumonia is widely performed, and total pneumonia volume, ground-glass opacity (GGO), and consolidation affect disease severity. However, there is insufficient information on how consolidation to GGO (C/G) ratio correlates with clinical characteristics including disease severity and complications in COVID-19 patients.</p><p><strong>Methods: </strong>This retrospective cohort study included 1,194 hospitalized patients with COVID-19 from four member hospitals of the Japan COVID-19 Task Force. Critical outcomes were defined as conditions requiring high-flow oxygen or invasive mechanical ventilation, or death. Patients were divided into two groups based on %pneumonia (percentage of pneumonia volume divided by total lung volume) using receiver operating characteristic curve, and those with high %pneumonia were further divided into two groups based on C/G ratio. Critical outcomes and complications were then compared between high and low C/G ratio groups.</p><p><strong>Results: </strong>The optimal cutoff value of %pneumonia to predict critical outcomes was 17.1%, classifying the included patients into low (Group 1, n = 900) and high (n = 294) %pneumonia groups. The optimal cutoff value of C/G ratio was 0.202, classifying patients in the high %pneumonia group into two groups: low (Group 2, n = 192) and high C/G (Group 3, n = 102) ratio groups. The incidence of critical outcomes was stair-step high in all three groups (2.1%, 21.4%, and 37.3%, respectively). Multivariable analysis revealed an independent relationship between C/G ratio and critical outcomes from other known risk factors (adjusted odds ratio: 1.92, 95% confidential interval: 1.03-3.59, P = 0.040). Group 3 also showed significantly higher serum C-reactive protein (Group 1: 2.96 mg/dL, Group 2: 8.90 mg/dL, Group 3: 11.4 mg/dL) and procalcitonin (Group 1: 0.16 ng/mL, Group 2: 0.25 ng/mL, Group 3: 1.19 ng/mL) levels and incidence of bacterial infection (Group 1: 5.6%, Group 2: 10.4%, Group 3: 20.3%), compared with other groups.</p><p><strong>Conclusions: </strong>CT-density analysis of COVID-19 pneumonia in a large patient population showed that C/G ratio was a significant predictor of critical outcomes and useful for prognosis evaluation.</p>","PeriodicalId":9148,"journal":{"name":"BMC Pulmonary Medicine","volume":"25 1","pages":"550"},"PeriodicalIF":2.8,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12667167/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145652943","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}