Pub Date : 2026-01-20DOI: 10.1016/j.resinv.2026.101373
A. Taha , M.S. Muneer , A. Kalra , M. Muelly , J. Reicher
Background
Several limitations hinder the effectiveness of human-based lung cancer screening (LCS): high false-positive rates leading to unnecessary follow-up imaging, procedures, and surgeries; inter-reader variability; inconsistent Lung-RADS adherence; and fatigue-related diagnostic errors. Additionally, most artificial intelligence (AI) models address only one task (nodule detection or risk stratification) and require manual image processing, which is time-consuming and costly. We developed Bronchosolve, a closed-loop, fully-automated software that processes scans without manual input, aiming to improve consistency, accuracy, and throughput in LCS.
Methods
The software integrates pre-processing, analysis, and result generation, using a deep-learning convolutional neural network (CNN) for pulmonary nodule triaging. Inputs were full chest CT scans in DICOM format, without clinical or demographic data. Automated steps included: 1) optimal CT series selection, 2) normalization and preprocessing, 3) AI-based detection and classification of suspicious nodules, and 4) report generation. The model was trained on a multi-center high-prevalence set of 2358 cases (malignant and benign nodules). Validation used a U.S.-based, multi-site cohort (n = 184; 8 sites). Positive cases were biopsy-confirmed within 1 year; negatives had biopsy or ≥2-year follow-up.
Results
All cases completed automatically (100 % success). Median age was 62.5 years (IQR 58.5–66.5); 45 % former smokers, 55 % current smokers, and 40 % female. The model achieved an AUC of 0.898 [0.851–0.940], outperforming Lung-RADS (pAUC 0.669) and the Brock model (AUC 0.783). Sensitivity was 83.6 %; specificity was 86.3 %. Performance remained consistent across scanner types and slice thicknesses.
Conclusions
Bronchosolve enables accurate, fully-automated risk classification of lung nodules and may enhance non-invasive diagnostic workflows.
{"title":"Performance validation of a closed loop fully automated AI model for lung nodule stratification in screening cases","authors":"A. Taha , M.S. Muneer , A. Kalra , M. Muelly , J. Reicher","doi":"10.1016/j.resinv.2026.101373","DOIUrl":"10.1016/j.resinv.2026.101373","url":null,"abstract":"<div><h3>Background</h3><div>Several limitations hinder the effectiveness of human-based lung cancer screening (LCS): high false-positive rates leading to unnecessary follow-up imaging, procedures, and surgeries; inter-reader variability; inconsistent Lung-RADS adherence; and fatigue-related diagnostic errors. Additionally, most artificial intelligence (AI) models address only one task (nodule detection or risk stratification) and require manual image processing, which is time-consuming and costly. We developed Bronchosolve, a closed-loop, fully-automated software that processes scans without manual input, aiming to improve consistency, accuracy, and throughput in LCS.</div></div><div><h3>Methods</h3><div>The software integrates pre-processing, analysis, and result generation, using a deep-learning convolutional neural network (CNN) for pulmonary nodule triaging. Inputs were full chest CT scans in DICOM format, without clinical or demographic data. Automated steps included: 1) optimal CT series selection, 2) normalization and preprocessing, 3) AI-based detection and classification of suspicious nodules, and 4) report generation. The model was trained on a multi-center high-prevalence set of 2358 cases (malignant and benign nodules). Validation used a U.S.-based, multi-site cohort (n = 184; 8 sites). Positive cases were biopsy-confirmed within 1 year; negatives had biopsy or ≥2-year follow-up.</div></div><div><h3>Results</h3><div>All cases completed automatically (100 % success). Median age was 62.5 years (IQR 58.5–66.5); 45 % former smokers, 55 % current smokers, and 40 % female. The model achieved an AUC of 0.898 [0.851–0.940], outperforming Lung-RADS (pAUC 0.669) and the Brock model (AUC 0.783). Sensitivity was 83.6 %; specificity was 86.3 %. Performance remained consistent across scanner types and slice thicknesses.</div></div><div><h3>Conclusions</h3><div>Bronchosolve enables accurate, fully-automated risk classification of lung nodules and may enhance non-invasive diagnostic workflows.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"64 2","pages":"Article 101373"},"PeriodicalIF":2.0,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-20DOI: 10.1016/j.resinv.2026.101375
Doppo Fukui , Daisuke Morinaga , Jun Sakakibara-Konishi , Yukiko Yoshida , Masahiro Kashima , Shotaro Ito , Megumi Furuta , Yuta Takashima , Zenichi Tanei , Satoshi Konno
A comprehensive pathological evaluation is useful for diagnosing synchronous multiple primary lung cancer (sMPLC). However, a consensus regarding treatment for sMPLC with different driver mutations is lacking. We present a case of sMPLC harboring an epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) fusion gene. For the advanced EGFR-positive tumor, osimertinib plus chemotherapy was initiated, the latter also covering ALK-positive tumor. A marked response and slight reduction occurred in the EGFR-positive and ALK-positive tumors, respectively. Surgical resection of the ALK-positive tumor achieved negative margins. Targeted therapy with chemotherapy may effectively treat sMPLC with different driver mutations.
{"title":"A case of synchronous multiple primary lung cancers each harboring an EGFR mutation or an ALK fusion gene alone that responded to osimertinib with chemotherapy","authors":"Doppo Fukui , Daisuke Morinaga , Jun Sakakibara-Konishi , Yukiko Yoshida , Masahiro Kashima , Shotaro Ito , Megumi Furuta , Yuta Takashima , Zenichi Tanei , Satoshi Konno","doi":"10.1016/j.resinv.2026.101375","DOIUrl":"10.1016/j.resinv.2026.101375","url":null,"abstract":"<div><div>A comprehensive pathological evaluation is useful for diagnosing synchronous multiple primary lung cancer (sMPLC). However, a consensus regarding treatment for sMPLC with different driver mutations is lacking. We present a case of sMPLC harboring an epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) fusion gene. For the advanced EGFR-positive tumor, osimertinib plus chemotherapy was initiated, the latter also covering ALK-positive tumor. A marked response and slight reduction occurred in the EGFR-positive and ALK-positive tumors, respectively. Surgical resection of the ALK-positive tumor achieved negative margins. Targeted therapy with chemotherapy may effectively treat sMPLC with different driver mutations.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"64 2","pages":"Article 101375"},"PeriodicalIF":2.0,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Acute exacerbation (AE) is a critical prognostic event in interstitial lung diseases (ILDs), initially recognized in idiopathic pulmonary fibrosis (IPF). Current AE diagnostic criteria do not account for oxygenation deterioration, and evidence of new computed tomography (CT) findings alone is insufficient to diagnose AE-ILD. We investigated a CT-based criterion for distinguishing AE from acute deterioration (AD)-ILD and assessed the prognostic significance of oxygenation deterioration in AE-ILD.
Methods
Patients with AD-ILD, defined by worsening shortness of breath and new lung abnormalities within 1 month, were prospectively enrolled. AD-ILD included both AE-ILD and other acute conditions, non-AE-AD-ILD. Oxygenation deterioration was assessed using modified Blancal criteria. CT-based AE criteria were developed through receiver operating characteristic (ROC) curve and multivariate logistic regression analyses based on CT findings suggestive of AE.
Results
Overall, 394 patients were analyzed, including 303 diagnosed with AE and 91 with non-AE-AD-ILD. The underlying ILDs included IPF (n = 177) and non-IPF ILDs (n = 217). The presence of at least two of three CT-based parameters, including bilateral shadows, ground-glass opacity predominance, and diffuse pattern, was identified as predictive of AE diagnosis in AD-ILDs using logistic and ROC analyses. Ninety-day survival was significantly lower in patients with AE-ILD with oxygenation deterioration than in those without deterioration and in patients with non-AE-AD-ILDs. Oxygenation deterioration independently predicted poor survival in multivariate Cox proportional hazard regression analysis.
Conclusions
The developed CT-based AE criteria effectively predicted AE and oxygenation deterioration in AD-ILD. Additionally, oxygenation deterioration predicted worse survival in AE-ILD.
This study was registered with the University Hospital Medical Information Network (UMIN000027844; registered 1 July 2017).
背景：急性加重（AE）是间质性肺疾病（ILDs）的一个关键预后事件，最初在特发性肺纤维化（IPF）中得到认可。目前的AE诊断标准没有考虑到氧合恶化，仅凭新的计算机断层扫描（CT）发现的证据不足以诊断AE- ild。我们研究了一种基于ct的区分AE与急性恶化(AD)-ILD的标准，并评估了AE-ILD中氧合恶化的预后意义。方法：前瞻性纳入AD-ILD患者，其定义为1个月内呼吸短促加重和新的肺部异常。AD-ILD包括AE-ILD和其他急性疾病，非ae -AD-ILD。采用改良Blancal标准评估氧合恶化。根据提示AE的CT表现，通过受试者工作特征（ROC）曲线和多因素logistic回归分析，制定基于CT的AE标准。结果：总共分析了394例患者，其中303例诊断为AE， 91例诊断为非AE- ad - ild。基础ild包括IPF （n = 177）和非IPF （n = 217）。通过logistic和ROC分析，三种基于ct的参数中至少两种的存在，包括双侧阴影、磨玻璃不透明优势和弥漫性模式，被确定为ad - ild声发射诊断的预测指标。伴氧合恶化的AE-ILD患者的90天生存率明显低于无氧合恶化患者和非ae - ad - ild患者。在多变量Cox比例风险回归分析中，氧合恶化独立预测生存不良。结论：建立的基于ct的AE标准可有效预测AD-ILD的AE和氧合恶化。此外，氧合恶化预示着AE-ILD患者更差的生存。本研究已在大学医院医疗信息网络注册（UMIN000027844，注册日期为2017年7月1日）。
{"title":"Oxygenation deterioration and computed tomography findings in acute exacerbation of interstitial lung diseases: a prospective observational study","authors":"Toru Arai , Junji Otsuka , Shinobu Akagawa , Yoriyuki Murata , Hidetoshi Yanai , Ryoji Ito , Takuo Shibayama , Toshihiko Ii , Toshiyuki Kita , Yoshifusa Koreeda , Takayasu Watanabe , Isoko Owan , Atsuko Hara , Kentaro Wakamatsu , Akihiro Yoshii , Shiro Ohshima , Shin Sasaki , Susumu Oguri , Naoki Arai , Eiji Yatsuyanagi , Hiromitsu Sumikawa","doi":"10.1016/j.resinv.2025.101361","DOIUrl":"10.1016/j.resinv.2025.101361","url":null,"abstract":"<div><h3>Background</h3><div>Acute exacerbation (AE) is a critical prognostic event in interstitial lung diseases (ILDs), initially recognized in idiopathic pulmonary fibrosis (IPF). Current AE diagnostic criteria do not account for oxygenation deterioration, and evidence of new computed tomography (CT) findings alone is insufficient to diagnose AE-ILD. We investigated a CT-based criterion for distinguishing AE from acute deterioration (AD)-ILD and assessed the prognostic significance of oxygenation deterioration in AE-ILD.</div></div><div><h3>Methods</h3><div>Patients with AD-ILD, defined by worsening shortness of breath and new lung abnormalities within 1 month, were prospectively enrolled. AD-ILD included both AE-ILD and other acute conditions, non-AE-AD-ILD. Oxygenation deterioration was assessed using modified Blancal criteria. CT-based AE criteria were developed through receiver operating characteristic (ROC) curve and multivariate logistic regression analyses based on CT findings suggestive of AE.</div></div><div><h3>Results</h3><div>Overall, 394 patients were analyzed, including 303 diagnosed with AE and 91 with non-AE-AD-ILD. The underlying ILDs included IPF (n = 177) and non-IPF ILDs (n = 217). The presence of at least two of three CT-based parameters, including bilateral shadows, ground-glass opacity predominance, and diffuse pattern, was identified as predictive of AE diagnosis in AD-ILDs using logistic and ROC analyses. Ninety-day survival was significantly lower in patients with AE-ILD with oxygenation deterioration than in those without deterioration and in patients with non-AE-AD-ILDs. Oxygenation deterioration independently predicted poor survival in multivariate Cox proportional hazard regression analysis.</div></div><div><h3>Conclusions</h3><div>The developed CT-based AE criteria effectively predicted AE and oxygenation deterioration in AD-ILD. Additionally, oxygenation deterioration predicted worse survival in AE-ILD.</div><div>This study was registered with the University Hospital Medical Information Network (UMIN000027844; registered 1 July 2017).</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"64 2","pages":"Article 101361"},"PeriodicalIF":2.0,"publicationDate":"2026-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146011672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adherence to peak expiratory flow monitoring in asthma management is low because of the burden of data recording. We developed a smartphone application that helps record and monitor patients’ daily PEF.
Methods
PEF recordings and application usage were assessed over 4 weeks. Respiratory function was measured in the laboratory. We analyzed the peak flow recording rates, variability, and correlations between the collected data.
Results
The recording rates for asthma and non-asthma groups were 83.9 % and 73.2 %, respectively, twice daily. Participants with asthma found the application more user-friendly than paper diaries, and 90 % wanted to continue using it. The maximum PEF recorded with the application and the PEF collected through spirometry were correlated.
Conclusion
Our application can be a useful tool for evaluating asthma. Future studies involving larger patient cohorts are needed to confirm the usefulness of this smartphone application.
{"title":"Feasibility testing of a smartphone application for visualizing and sharing peak flow monitoring data in asthma evaluation","authors":"Kotaro Sasahara, Yuma Sakai, Katsunori Masaki, Saki Tomiyasu, Ryuta Onozato, Shiori Mori, Kaoru Koyama, Yo Otsu, Momoko Kurihara, Emiko Matsuyama, Reina Nakamura, Keeya Sunata, Masato Asaoka, Yuto Akiyama, Misato Irie, Hiroki Kabata, Jun Miyata, Koichi Fukunaga","doi":"10.1016/j.resinv.2025.101364","DOIUrl":"10.1016/j.resinv.2025.101364","url":null,"abstract":"<div><h3>Background</h3><div>Adherence to peak expiratory flow monitoring in asthma management is low because of the burden of data recording. We developed a smartphone application that helps record and monitor patients’ daily PEF.</div></div><div><h3>Methods</h3><div>PEF recordings and application usage were assessed over 4 weeks. Respiratory function was measured in the laboratory. We analyzed the peak flow recording rates, variability, and correlations between the collected data.</div></div><div><h3>Results</h3><div>The recording rates for asthma and non-asthma groups were 83.9 % and 73.2 %, respectively, twice daily. Participants with asthma found the application more user-friendly than paper diaries, and 90 % wanted to continue using it. The maximum PEF recorded with the application and the PEF collected through spirometry were correlated.</div></div><div><h3>Conclusion</h3><div>Our application can be a useful tool for evaluating asthma. Future studies involving larger patient cohorts are needed to confirm the usefulness of this smartphone application.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"64 2","pages":"Article 101364"},"PeriodicalIF":2.0,"publicationDate":"2026-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145998938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Information on the incidence and clinical characteristics of respiratory syncytial virus (RSV) infections among adults remains limited in Japan. In this study, we aimed to clarify these aspects among adult outpatients at our institution.
Methods
This single-center, retrospective observational study included outpatients aged 18 years and older who presented with fever or respiratory symptoms and underwent multiplex PCR testing of nasopharyngeal specimens between April 2021 and March 2025. We assessed the RSV positive rate, underlying comorbidities, and hospitalization rate. For those with pneumonia, we analyzed their imaging findings and sputum culture results. Clinical characteristics were also compared between hospitalized and nonhospitalized patients aged 60 years or older.
Results
The overall positive rate of RSV infection over the 4 years was 2.3 %. Among individuals aged 60 years and older, the positive rate was 2.3 %. Of the 31 hospitalized cases, 29 were aged 60 years or older, accounting for 36.3 % of all RSV-positive patients in this age group. Age significantly differed between the hospitalized and nonhospitalized groups aged 60 and older. Among 24 patients with pneumonia who underwent computed tomography scans, 11 had positive sputum cultures. Consolidation was significantly more frequent in the 11 culture-positive cases than in the remaining 13 cases.
Conclusions
RSV infection accounted for 2.3 % of adult outpatient cases, with a notably high hospitalization rate in older adults. These findings highlight RSV as an important respiratory pathogen in older adults, underscoring the need to expand diagnostic testing and preventive strategies in this population.
{"title":"Real-world clinical data on adult respiratory syncytial virus infection in a Japanese community hospital: Emphasis on positivity rate, older adults, and pneumonia cases","authors":"Hiroyuki Honda , Koji Kuronuma , Yutaro Nagano , Kanami Nagano , Kojirou Uemura , Midori Hashimoto , Kaoru Nishiyama , Hirofumi Chiba","doi":"10.1016/j.resinv.2026.101371","DOIUrl":"10.1016/j.resinv.2026.101371","url":null,"abstract":"<div><h3>Background</h3><div>Information on the incidence and clinical characteristics of respiratory syncytial virus (RSV) infections among adults remains limited in Japan. In this study, we aimed to clarify these aspects among adult outpatients at our institution.</div></div><div><h3>Methods</h3><div>This single-center, retrospective observational study included outpatients aged 18 years and older who presented with fever or respiratory symptoms and underwent multiplex PCR testing of nasopharyngeal specimens between April 2021 and March 2025. We assessed the RSV positive rate, underlying comorbidities, and hospitalization rate. For those with pneumonia, we analyzed their imaging findings and sputum culture results. Clinical characteristics were also compared between hospitalized and nonhospitalized patients aged 60 years or older.</div></div><div><h3>Results</h3><div>The overall positive rate of RSV infection over the 4 years was 2.3 %. Among individuals aged 60 years and older, the positive rate was 2.3 %. Of the 31 hospitalized cases, 29 were aged 60 years or older, accounting for 36.3 % of all RSV-positive patients in this age group. Age significantly differed between the hospitalized and nonhospitalized groups aged 60 and older. Among 24 patients with pneumonia who underwent computed tomography scans, 11 had positive sputum cultures. Consolidation was significantly more frequent in the 11 culture-positive cases than in the remaining 13 cases.</div></div><div><h3>Conclusions</h3><div>RSV infection accounted for 2.3 % of adult outpatient cases, with a notably high hospitalization rate in older adults. These findings highlight RSV as an important respiratory pathogen in older adults, underscoring the need to expand diagnostic testing and preventive strategies in this population.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"64 2","pages":"Article 101371"},"PeriodicalIF":2.0,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145966725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Delamanid is a nitro-dihydro-imidazooxazole derivative that possesses highly potent activity against Mycobacterium tuberculosis, including strains linked to multidrug-resistant tuberculosis (MDR-TB). We conducted an all-case post-marketing surveillance to assess the real-world safety and effectiveness of delamanid in treating MDR-TB in Japan.
Methods
All patients diagnosed with MDR-TB were included if they started delamanid between September 2014 and February 2023. Case report forms were collected every 6 months during the treatment period and every 12 months during the follow-up period. Safety assessment included any adverse events that occurred during the treatment period. Effectiveness assessment included the proportion of patients with sputum-culture conversion and treatment success.
Results
In the safety analysis set, 61.6 % of patients (114/185) were males, and the median (interquartile range) age was 48.0 (32.0, 64.0) years. During the treatment period, 54.05 % of patients (100/185) experienced adverse drug reactions (ADRs), and 8.65 % (16/185) experienced serious ADRs. Electrocardiogram QT prolongation was reported in 8.65 % of patients (16/185) but was not associated with an increased risk of cardiovascular events. In the sputum-culture conversion analysis set, sputum-culture conversion was achieved in 86.0 % of patients (80/93). In the effectiveness analysis set, treatment success was achieved in 54.1 % of patients (99/183) by the end of the treatment period.
Conclusions
This surveillance showed the effectiveness of ≥6 months of delamanid treatment among patients with MDR-TB in real-world settings in Japan, with no new safety issues identified.
{"title":"All-case post-marketing surveillance of delamanid for treating multidrug-resistant pulmonary tuberculosis in Japan","authors":"Toru Mori , Kazunari Tsuyuguchi , Takefumi Saito , Yuka Sasaki , Eriko Shigeto , Hideaki Nagai , Satoshi Komaniwa , Hiroyuki Hashizume , Kyoko Suzue , Yuko Yamashige , Takashi Yoshiyama","doi":"10.1016/j.resinv.2025.101363","DOIUrl":"10.1016/j.resinv.2025.101363","url":null,"abstract":"<div><h3>Background</h3><div>Delamanid is a nitro-dihydro-imidazooxazole derivative that possesses highly potent activity against <em>Mycobacterium tuberculosis</em>, including strains linked to multidrug-resistant tuberculosis (MDR-TB). We conducted an all-case post-marketing surveillance to assess the real-world safety and effectiveness of delamanid in treating MDR-TB in Japan.</div></div><div><h3>Methods</h3><div>All patients diagnosed with MDR-TB were included if they started delamanid between September 2014 and February 2023. Case report forms were collected every 6 months during the treatment period and every 12 months during the follow-up period. Safety assessment included any adverse events that occurred during the treatment period. Effectiveness assessment included the proportion of patients with sputum-culture conversion and treatment success.</div></div><div><h3>Results</h3><div>In the safety analysis set, 61.6 % of patients (114/185) were males, and the median (interquartile range) age was 48.0 (32.0, 64.0) years. During the treatment period, 54.05 % of patients (100/185) experienced adverse drug reactions (ADRs), and 8.65 % (16/185) experienced serious ADRs. Electrocardiogram QT prolongation was reported in 8.65 % of patients (16/185) but was not associated with an increased risk of cardiovascular events. In the sputum-culture conversion analysis set, sputum-culture conversion was achieved in 86.0 % of patients (80/93). In the effectiveness analysis set, treatment success was achieved in 54.1 % of patients (99/183) by the end of the treatment period.</div></div><div><h3>Conclusions</h3><div>This surveillance showed the effectiveness of ≥6 months of delamanid treatment among patients with MDR-TB in real-world settings in Japan, with no new safety issues identified.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"64 2","pages":"Article 101363"},"PeriodicalIF":2.0,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145941428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-09DOI: 10.1016/j.resinv.2025.101357
Kozo Morimoto , James D. Chalmers , Pierre-Régis Burgel , Charles L. Daley , Anthony De Soyza , David Mauger , Mark L. Metersky , Xiangmin Zhang , Sherry Li , Yuhei Goto , Ariel Teper , Carlos Fernandez , Naoki Hasegawa
Background
In the ASPEN trial (NCT04594369), brensocatib 10 mg and 25 mg significantly reduced the burden of pulmonary exacerbations (annualized rate [primary endpoint], time to first, proportion exacerbation-free) over 52 weeks vs placebo in patients with bronchiectasis; brensocatib 25 mg significantly reduced lung function decline and nominally significantly improved patient-reported symptoms. Here we report efficacy and safety for Japanese patients.
Methods
Adults with bronchiectasis with ≥2 exacerbations in the 12 months before screening were randomized to once-daily brensocatib (10 mg or 25 mg) or placebo for 52 weeks. Endpoints included annualized exacerbation rate, time to first exacerbation, proportion remaining exacerbation-free, change from baseline in lung function, severe exacerbation rate, and change from baseline in patient-reported symptoms.
Results
Baseline characteristics of Japanese patients (n = 87) were generally consistent across groups. Brensocatib 10 mg and 25 mg reduced the annualized exacerbation rate vs placebo (rate ratio, 0.37 [95 % CI, 0.16–0.87]; 0.32 [0.14–0.75]), prolonged time to first exacerbation, and increased odds of remaining exacerbation-free. The annualized severe exacerbation rate was lower with brensocatib 10 mg and 25 mg vs placebo (rate ratio, 0.11 [0.01–1.04]; 0.30 [0.06–1.62]). Brensocatib, particularly at the 25 mg dose, also reduced lung function decline vs placebo (LS mean difference: forced expiratory volume in 1 s, 97 mL [95 % CI, 32–162]; forced vital capacity, 164 mL [84−244]) and improved patient-reported symptoms. Adverse events were similar across groups.
Conclusions
Consistent with overall ASPEN results, brensocatib 10 mg and 25 mg reduced exacerbation frequency vs placebo in Japanese patients with bronchiectasis. Lung function, patient-reported symptoms, and safety data were consistent with overall ASPEN trial results.
{"title":"Efficacy and safety of brensocatib in Japanese patients with non-cystic fibrosis bronchiectasis: Analysis of the ASPEN trial","authors":"Kozo Morimoto , James D. Chalmers , Pierre-Régis Burgel , Charles L. Daley , Anthony De Soyza , David Mauger , Mark L. Metersky , Xiangmin Zhang , Sherry Li , Yuhei Goto , Ariel Teper , Carlos Fernandez , Naoki Hasegawa","doi":"10.1016/j.resinv.2025.101357","DOIUrl":"10.1016/j.resinv.2025.101357","url":null,"abstract":"<div><h3>Background</h3><div>In the ASPEN trial (NCT04594369), brensocatib 10 mg and 25 mg significantly reduced the burden of pulmonary exacerbations (annualized rate [primary endpoint], time to first, proportion exacerbation-free) over 52 weeks vs placebo in patients with bronchiectasis; brensocatib 25 mg significantly reduced lung function decline and nominally significantly improved patient-reported symptoms. Here we report efficacy and safety for Japanese patients.</div></div><div><h3>Methods</h3><div>Adults with bronchiectasis with ≥2 exacerbations in the 12 months before screening were randomized to once-daily brensocatib (10 mg or 25 mg) or placebo for 52 weeks. Endpoints included annualized exacerbation rate, time to first exacerbation, proportion remaining exacerbation-free, change from baseline in lung function, severe exacerbation rate, and change from baseline in patient-reported symptoms.</div></div><div><h3>Results</h3><div>Baseline characteristics of Japanese patients (n = 87) were generally consistent across groups. Brensocatib 10 mg and 25 mg reduced the annualized exacerbation rate vs placebo (rate ratio, 0.37 [95 % CI, 0.16–0.87]; 0.32 [0.14–0.75]), prolonged time to first exacerbation, and increased odds of remaining exacerbation-free. The annualized severe exacerbation rate was lower with brensocatib 10 mg and 25 mg vs placebo (rate ratio, 0.11 [0.01–1.04]; 0.30 [0.06–1.62]). Brensocatib, particularly at the 25 mg dose, also reduced lung function decline vs placebo (LS mean difference: forced expiratory volume in 1 s, 97 mL [95 % CI, 32–162]; forced vital capacity, 164 mL [84−244]) and improved patient-reported symptoms. Adverse events were similar across groups.</div></div><div><h3>Conclusions</h3><div>Consistent with overall ASPEN results, brensocatib 10 mg and 25 mg reduced exacerbation frequency vs placebo in Japanese patients with bronchiectasis. Lung function, patient-reported symptoms, and safety data were consistent with overall ASPEN trial results.</div></div><div><h3>Clinical trial registration</h3><div>NCT04594369.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"64 2","pages":"Article 101357"},"PeriodicalIF":2.0,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145941429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-08DOI: 10.1016/j.resinv.2025.101360
Shigeo Muro , Kazuya Tanimura , Mitsuhiro Yamada , Shuichiro Maruoka , Hisatoshi Sugiura , Yasuhiro Gon , the members of the Japanese Respiratory Society Guidelines for the Diagnosis and Treatment of Asthma and COPD Overlap 2023 Editing Committee
Many patients have overlapping features of asthma and chronic obstructive pulmonary disease (COPD), but not all of them receive appropriate treatment for both conditions. The Japanese Respiratory Society published the guidelines on the diagnosis and treatment of asthma and COPD overlap (ACO) to promote its awareness. This English summary of the revised edition highlights the concepts, definitions, clinical features, diagnosis, and management of ACO based on recent evidence from observational studies. It also discusses the updates to the evaluation of ACO severity, workflow of management, and pharmacological treatment strategy. ACO is characterized by chronic airflow limitation with features of both asthma and COPD, and its diagnostic algorithm based on the clinical features and multidimensional evaluation, including imaging and functional tests, is provided. The classification of ACO severity based on exacerbations and symptoms is also advocated. There is no consensus on the treatment strategy for ACO, but the guidelines propose a pharmacotherapy strategy based on this classification to prevent under- or over-treatment. ACO requires a comprehensive approach that includes tailored pharmacological and non-pharmacological therapies. These guidelines will contribute to advancing research on the characteristics and pathophysiology of ACO and facilitate discussions on its management.
{"title":"Summary of the Japanese Respiratory Society guidelines for the diagnosis and treatment of asthma and chronic obstructive pulmonary disease overlap 2023 (2nd edition)","authors":"Shigeo Muro , Kazuya Tanimura , Mitsuhiro Yamada , Shuichiro Maruoka , Hisatoshi Sugiura , Yasuhiro Gon , the members of the Japanese Respiratory Society Guidelines for the Diagnosis and Treatment of Asthma and COPD Overlap 2023 Editing Committee","doi":"10.1016/j.resinv.2025.101360","DOIUrl":"10.1016/j.resinv.2025.101360","url":null,"abstract":"<div><div>Many patients have overlapping features of asthma and chronic obstructive pulmonary disease (COPD), but not all of them receive appropriate treatment for both conditions. The Japanese Respiratory Society published the guidelines on the diagnosis and treatment of asthma and COPD overlap (ACO) to promote its awareness. This English summary of the revised edition highlights the concepts, definitions, clinical features, diagnosis, and management of ACO based on recent evidence from observational studies. It also discusses the updates to the evaluation of ACO severity, workflow of management, and pharmacological treatment strategy. ACO is characterized by chronic airflow limitation with features of both asthma and COPD, and its diagnostic algorithm based on the clinical features and multidimensional evaluation, including imaging and functional tests, is provided. The classification of ACO severity based on exacerbations and symptoms is also advocated. There is no consensus on the treatment strategy for ACO, but the guidelines propose a pharmacotherapy strategy based on this classification to prevent under- or over-treatment. ACO requires a comprehensive approach that includes tailored pharmacological and non-pharmacological therapies. These guidelines will contribute to advancing research on the characteristics and pathophysiology of ACO and facilitate discussions on its management.</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"64 2","pages":"Article 101360"},"PeriodicalIF":2.0,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145908766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Recently proposed multidimensional chronic obstructive pulmonary disease (COPD) diagnostic criteria incorporate computed tomography (CT) findings and symptoms beyond airflow limitation. These criteria, developed using North American cohorts, require validation in Asian populations in which COPD phenotypes differ. We examined whether these criteria identify Japanese smokers at increased exacerbation risk, particularly those without airflow limitation.
Methods
This retrospective analysis pooled data from two prospective Japanese cohorts (Kyoto-Himeji and K-CCR) that included 517 smokers aged ≥40 years undergoing chest CT and COPD assessment test (CAT). The criteria included one major criterion (airflow limitation) and five minor criteria (emphysema [low attenuation area percent, LAA% ≥5 %], airway wall thickening [wall area percent ≥60 %], symptoms, dyspnea, and chronic bronchitis). COPD was defined as meeting the major criterion plus ≥1 minor criterion or ≥3 minor criteria alone. Negative binomial regression examined three-year exacerbation risk.
Results
Among 517 smokers, 364 had major criteria COPD, 26 had minor criteria-only COPD, 40 had airflow limitation without meeting COPD criteria, and 87 had neither (non-COPD group). Exacerbation rates were 0.270, 0.259, 0.161, and 0.069 per person-year, respectively. Both COPD groups had a significantly greater exacerbation risk than the non-COPD group (adjusted IRR: 4.95 [95 %CI: 1.79–14.62] for minor criteria-only; 3.95 [2.06–7.79] for major criteria). Higher CAT scores and LAA % were independently associated with a greater exacerbation risk in patients with COPD.
Conclusion
The new multidimensional COPD criteria successfully identified Japanese smokers at increased exacerbation risk, including those without airflow limitation, supporting their applicability across different populations. Registered at UMIN (UMIN000028387).
{"title":"Identifying high-risk smokers without airflow limitation using new COPD criteria: pooled analysis of two Japanese cohorts","authors":"Naoya Tanabe , Shotaro Chubachi , Kunihiko Terada , Takashi Shimada , Yoshinori Seri , Hidetoshi Nakamura , Koichiro Asano , Atsuyasu Sato , Susumu Sato , Koichi Fukunaga , Toyohiro Hirai","doi":"10.1016/j.resinv.2026.101368","DOIUrl":"10.1016/j.resinv.2026.101368","url":null,"abstract":"<div><h3>Background</h3><div>Recently proposed multidimensional chronic obstructive pulmonary disease (COPD) diagnostic criteria incorporate computed tomography (CT) findings and symptoms beyond airflow limitation. These criteria, developed using North American cohorts, require validation in Asian populations in which COPD phenotypes differ. We examined whether these criteria identify Japanese smokers at increased exacerbation risk, particularly those without airflow limitation.</div></div><div><h3>Methods</h3><div>This retrospective analysis pooled data from two prospective Japanese cohorts (Kyoto-Himeji and K-CCR) that included 517 smokers aged ≥40 years undergoing chest CT and COPD assessment test (CAT). The criteria included one major criterion (airflow limitation) and five minor criteria (emphysema [low attenuation area percent, LAA% ≥5 %], airway wall thickening [wall area percent ≥60 %], symptoms, dyspnea, and chronic bronchitis). COPD was defined as meeting the major criterion plus ≥1 minor criterion or ≥3 minor criteria alone. Negative binomial regression examined three-year exacerbation risk.</div></div><div><h3>Results</h3><div>Among 517 smokers, 364 had major criteria COPD, 26 had minor criteria-only COPD, 40 had airflow limitation without meeting COPD criteria, and 87 had neither (non-COPD group). Exacerbation rates were 0.270, 0.259, 0.161, and 0.069 per person-year, respectively. Both COPD groups had a significantly greater exacerbation risk than the non-COPD group (adjusted IRR: 4.95 [95 %CI: 1.79–14.62] for minor criteria-only; 3.95 [2.06–7.79] for major criteria). Higher CAT scores and LAA % were independently associated with a greater exacerbation risk in patients with COPD.</div></div><div><h3>Conclusion</h3><div>The new multidimensional COPD criteria successfully identified Japanese smokers at increased exacerbation risk, including those without airflow limitation, supporting their applicability across different populations. Registered at UMIN (UMIN000028387).</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"64 2","pages":"Article 101368"},"PeriodicalIF":2.0,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145941426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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