Pub Date : 2025-09-01Epub Date: 2025-07-14DOI: 10.1007/s41030-025-00305-2
Jean-Guillaume Starnini, Giulio Natalello, Federico Nigroli, Chiara Diana, Elena Bargagli, Andrea Sisto Melani
The evidence that tobacco cigarettes are harmful to the health of smokers led to the introduction of electronic nicotine delivery systems (ENDS) as a safer alternative. ENDS, which include electronic cigarettes (e-cigs) and heated tobacco products (battery-operated devices that heat a liquid and produce an aerosol), are portable, cheap, easy-to-use, self-powered devices, and resemble tobacco cigarettes. After an overview of the toxicological, clinical, and epidemiological implications associated with the increasingly widespread use of ENDS, this narrative paper evaluates their role as a smoking cessation aid. Randomized controlled trials show that e-cigs can help in achieving cigarette smoking cessation, but their role in real life is still debated. There is no clear association in current smokers between the prevalence of e-cig use and overall quit rates. Although ENDS are not Food and Drug Administration (FDA)- and European Medicines Agency (EMA)-approved for quitting, they are one of the most widely utilized pharmacological support devices for smoking cessation. Physicians should ask for ENDS use and amount at each visit, be able to advise on how to manage ENDS as an aid for quitting, encourage vapers not to continue their use indefinitely, and explain how to stop ENDS.
{"title":"Electronic Nicotine Delivery Systems (ENDS): Implications for the Clinician.","authors":"Jean-Guillaume Starnini, Giulio Natalello, Federico Nigroli, Chiara Diana, Elena Bargagli, Andrea Sisto Melani","doi":"10.1007/s41030-025-00305-2","DOIUrl":"10.1007/s41030-025-00305-2","url":null,"abstract":"<p><p>The evidence that tobacco cigarettes are harmful to the health of smokers led to the introduction of electronic nicotine delivery systems (ENDS) as a safer alternative. ENDS, which include electronic cigarettes (e-cigs) and heated tobacco products (battery-operated devices that heat a liquid and produce an aerosol), are portable, cheap, easy-to-use, self-powered devices, and resemble tobacco cigarettes. After an overview of the toxicological, clinical, and epidemiological implications associated with the increasingly widespread use of ENDS, this narrative paper evaluates their role as a smoking cessation aid. Randomized controlled trials show that e-cigs can help in achieving cigarette smoking cessation, but their role in real life is still debated. There is no clear association in current smokers between the prevalence of e-cig use and overall quit rates. Although ENDS are not Food and Drug Administration (FDA)- and European Medicines Agency (EMA)-approved for quitting, they are one of the most widely utilized pharmacological support devices for smoking cessation. Physicians should ask for ENDS use and amount at each visit, be able to advise on how to manage ENDS as an aid for quitting, encourage vapers not to continue their use indefinitely, and explain how to stop ENDS.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"387-404"},"PeriodicalIF":3.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144626972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-07-25DOI: 10.1007/s41030-025-00307-0
Tejaswini Kulkarni, David A Zisman, Oksana A Shlobin, David G Kiely, Maral DerSarkissian, Eric Shen, Kevin M Maher, Meredith Broderick, Mary Beth Scholand
Introduction: A common complication of interstitial lung disease (ILD) is pulmonary hypertension (PH), which is associated with increased morbidity and mortality and worsened quality of life. In ILD, evaluating for PH is recommended prior to lung transplantation. However, this is not standardized or routinely performed in earlier stages of ILD, and guidelines lack an evidence-based approach for PH screening in this population. Furthermore, right-heart catheterization (RHC) access can be limited in many settings. The objective of PHINDER (Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection) is to prospectively develop screening strategies for PH in patients with ILD.
Methods: PHINDER is a prospective, non-interventional study that will enroll approximately 200 patients with ILD treated in a variety of settings in the United States (community centers, academic institutions, etc.). Patients must be diagnosed with ILD by high-resolution computed tomography (HRCT) and must not have a previously reported mean pulmonary arterial pressure (mPAP) > 20 mmHg. To enrich the population for PH, patients must meet additional criteria on Pulmonary Function Tests, HRCT, signs/symptoms, 6-min walk test, or echocardiography. Patients will undergo a variety of routine ILD clinical assessments. Lastly, patients receive a RHC to assess for PH, defined as mPAP > 20 mmHg with pulmonary arterial wedge pressure ≤ 15 mmHg and a pulmonary vascular resistance > 2 Wood Units. All treatment decisions are at the discretion of the provider and not influenced by study participation.
Planned outcomes: Following study completion, statistical tools will be used to derive a practical model for a screening algorithm using the variables identified in the study as most predictive of PH in patients with ILD.
Conclusions: Using a previously developed list of clinical assessments from PH and ILD experts, the PHINDER study aims to be the first prospectively enrolled study to evaluate prognostic screening strategies that can be used to develop an algorithm to predict the risk of PH in patients with ILD.
{"title":"Study Design and Rationale for the PHINDER Study: Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection.","authors":"Tejaswini Kulkarni, David A Zisman, Oksana A Shlobin, David G Kiely, Maral DerSarkissian, Eric Shen, Kevin M Maher, Meredith Broderick, Mary Beth Scholand","doi":"10.1007/s41030-025-00307-0","DOIUrl":"10.1007/s41030-025-00307-0","url":null,"abstract":"<p><strong>Introduction: </strong>A common complication of interstitial lung disease (ILD) is pulmonary hypertension (PH), which is associated with increased morbidity and mortality and worsened quality of life. In ILD, evaluating for PH is recommended prior to lung transplantation. However, this is not standardized or routinely performed in earlier stages of ILD, and guidelines lack an evidence-based approach for PH screening in this population. Furthermore, right-heart catheterization (RHC) access can be limited in many settings. The objective of PHINDER (Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection) is to prospectively develop screening strategies for PH in patients with ILD.</p><p><strong>Methods: </strong>PHINDER is a prospective, non-interventional study that will enroll approximately 200 patients with ILD treated in a variety of settings in the United States (community centers, academic institutions, etc.). Patients must be diagnosed with ILD by high-resolution computed tomography (HRCT) and must not have a previously reported mean pulmonary arterial pressure (mPAP) > 20 mmHg. To enrich the population for PH, patients must meet additional criteria on Pulmonary Function Tests, HRCT, signs/symptoms, 6-min walk test, or echocardiography. Patients will undergo a variety of routine ILD clinical assessments. Lastly, patients receive a RHC to assess for PH, defined as mPAP > 20 mmHg with pulmonary arterial wedge pressure ≤ 15 mmHg and a pulmonary vascular resistance > 2 Wood Units. All treatment decisions are at the discretion of the provider and not influenced by study participation.</p><p><strong>Planned outcomes: </strong>Following study completion, statistical tools will be used to derive a practical model for a screening algorithm using the variables identified in the study as most predictive of PH in patients with ILD.</p><p><strong>Conclusions: </strong>Using a previously developed list of clinical assessments from PH and ILD experts, the PHINDER study aims to be the first prospectively enrolled study to evaluate prognostic screening strategies that can be used to develop an algorithm to predict the risk of PH in patients with ILD.</p><p><strong>Trail registration: </strong>NCT05776225.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"491-501"},"PeriodicalIF":3.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373579/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144708578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-07-11DOI: 10.1007/s41030-025-00303-4
Jaime L Rubin, Craig McKinnon, Gabriel Ghizzi Pedra, Devon A Morgan, Kimberly Zweig, Theodore G Liou
Introduction: Cystic fibrosis (CF) transmembrane conductance regulator modulators (CFTRm) have transformed CF care, shifting treatment from only managing symptoms to also addressing the underlying defects that cause CF. CFTRm first entered clinical practice in 2012 and was followed by additional CFTRm combinations-including the approval of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in 2019-which treats most CF genotypes.
Methods: We identified peer-reviewed literature for a narrative review (January 1990 to January 2025) describing longitudinal trends in CF survival and age of death and assessing the influence of CFTRm, particularly ELX/TEZ/IVA. To supplement the existing literature, a secondary analysis of historical, longitudinal trends in the United States CF Foundation Patient Registry (U.S. CFFPR, 1990-2023) was conducted using recent available data.
Results: Quantitative data from published studies show that the median age of survival and death increased over time but with varying magnitudes across regions. Most cohort and registry-based studies were conducted in settings where CFTRm were not yet widely available, limiting the evaluation of CFTRm effects on survival trends over time. In the secondary U.S. CFFPR analysis, the median survival age increased from 29.0 years in 1990 to 38.6 years in 2012 prior to the introduction of CFTRm and to 68.0 years in 2023, demonstrating substantial improvement following the introduction of CFTRm. Linear regression analyses showed gains in median survival age increased from 0.48 years per year prior to CFTRm to 4.79 years per year after approval of ELX/TEZ/IVA in 2019.
Conclusions: Study results provide initial evidence of the impact of CFTRm to meaningfully improve survival. Longer-term follow-up data across geographies will provide a deeper understanding of the full impact of CFTRm on predicted CF survival and mortality.
{"title":"Impact of CFTR Modulators on Longitudinal Cystic Fibrosis Survival and Mortality: Review and Secondary Analysis.","authors":"Jaime L Rubin, Craig McKinnon, Gabriel Ghizzi Pedra, Devon A Morgan, Kimberly Zweig, Theodore G Liou","doi":"10.1007/s41030-025-00303-4","DOIUrl":"10.1007/s41030-025-00303-4","url":null,"abstract":"<p><strong>Introduction: </strong>Cystic fibrosis (CF) transmembrane conductance regulator modulators (CFTRm) have transformed CF care, shifting treatment from only managing symptoms to also addressing the underlying defects that cause CF. CFTRm first entered clinical practice in 2012 and was followed by additional CFTRm combinations-including the approval of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in 2019-which treats most CF genotypes.</p><p><strong>Methods: </strong>We identified peer-reviewed literature for a narrative review (January 1990 to January 2025) describing longitudinal trends in CF survival and age of death and assessing the influence of CFTRm, particularly ELX/TEZ/IVA. To supplement the existing literature, a secondary analysis of historical, longitudinal trends in the United States CF Foundation Patient Registry (U.S. CFFPR, 1990-2023) was conducted using recent available data.</p><p><strong>Results: </strong>Quantitative data from published studies show that the median age of survival and death increased over time but with varying magnitudes across regions. Most cohort and registry-based studies were conducted in settings where CFTRm were not yet widely available, limiting the evaluation of CFTRm effects on survival trends over time. In the secondary U.S. CFFPR analysis, the median survival age increased from 29.0 years in 1990 to 38.6 years in 2012 prior to the introduction of CFTRm and to 68.0 years in 2023, demonstrating substantial improvement following the introduction of CFTRm. Linear regression analyses showed gains in median survival age increased from 0.48 years per year prior to CFTRm to 4.79 years per year after approval of ELX/TEZ/IVA in 2019.</p><p><strong>Conclusions: </strong>Study results provide initial evidence of the impact of CFTRm to meaningfully improve survival. Longer-term follow-up data across geographies will provide a deeper understanding of the full impact of CFTRm on predicted CF survival and mortality.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"365-386"},"PeriodicalIF":3.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373600/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144619858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-07-19DOI: 10.1007/s41030-025-00304-3
Abdullah Shehab, Huda Al Dhanhani, Omar Alhammadi, Mohamed Badi Hassan, Mohamed Farghaly, Ahmed Hassoun, Bassam Mahboub, Mona Tahlak, Reem Faisal Abutayeh, Hammam Haridy, Ashraf Hassanien, Jean Joury, Humaid O Al-Shamsi
Respiratory infections are a major cause of mortality among young children and adults, particularly the elderly or those with underlying medical conditions. Many respiratory infections, including influenza, COVID-19, pneumococcal disease, and respiratory syncytial virus (RSV), have available vaccines and antiviral agents. However, vaccine coverage rates remain low. Experts representing a broad spectrum of medical specialties from the United Arab Emirates (UAE) made evidence-based recommendations on treating patients considered high risk for respiratory infections, highlighting gaps in current practices and suggesting strategies for improved communication between healthcare professionals and patients. To effectively manage respiratory infections, the experts emphasized the importance of adhering to guidelines, considering all vaccines and antiviral treatments, and strictly following vaccination schedules. Early testing upon recognition of symptoms was also encouraged. Improving vaccine uptake was considered crucial and could be achieved by educating patients about disease prevention through vaccines and the role of antiviral treatments for COVID-19. Addressing knowledge gaps and combating vaccine hesitancy among both patients and healthcare professionals were also essential steps. Recommendations for future initiatives include healthcare professionals educating the public on precautionary measures to reduce the spread of respiratory infections. Additionally, the experts agreed that clinical management guidelines for chronic diseases should be updated to include preventative strategies such as vaccines, prophylaxis, and counselling. Monitoring the performance of healthcare facilities using key performance indicators is also recommended to ensure effective management and continuous improvement of vaccination programs. Patient populations in the UAE who are considered at high risk of serious disease from respiratory infections have diverse medical needs and may access healthcare across a wide range of settings and specialisms. Therefore, it is vital that all healthcare professionals across specialisms who may engage with these individuals are able to provide appropriate advice on managing the risk through vaccination, prompt testing, and treatments as needed.
{"title":"Strategies for the Prevention and Management of Respiratory Infections in Patients at High Risk in the UAE: A Cross-Disciplinary Position Paper.","authors":"Abdullah Shehab, Huda Al Dhanhani, Omar Alhammadi, Mohamed Badi Hassan, Mohamed Farghaly, Ahmed Hassoun, Bassam Mahboub, Mona Tahlak, Reem Faisal Abutayeh, Hammam Haridy, Ashraf Hassanien, Jean Joury, Humaid O Al-Shamsi","doi":"10.1007/s41030-025-00304-3","DOIUrl":"10.1007/s41030-025-00304-3","url":null,"abstract":"<p><p>Respiratory infections are a major cause of mortality among young children and adults, particularly the elderly or those with underlying medical conditions. Many respiratory infections, including influenza, COVID-19, pneumococcal disease, and respiratory syncytial virus (RSV), have available vaccines and antiviral agents. However, vaccine coverage rates remain low. Experts representing a broad spectrum of medical specialties from the United Arab Emirates (UAE) made evidence-based recommendations on treating patients considered high risk for respiratory infections, highlighting gaps in current practices and suggesting strategies for improved communication between healthcare professionals and patients. To effectively manage respiratory infections, the experts emphasized the importance of adhering to guidelines, considering all vaccines and antiviral treatments, and strictly following vaccination schedules. Early testing upon recognition of symptoms was also encouraged. Improving vaccine uptake was considered crucial and could be achieved by educating patients about disease prevention through vaccines and the role of antiviral treatments for COVID-19. Addressing knowledge gaps and combating vaccine hesitancy among both patients and healthcare professionals were also essential steps. Recommendations for future initiatives include healthcare professionals educating the public on precautionary measures to reduce the spread of respiratory infections. Additionally, the experts agreed that clinical management guidelines for chronic diseases should be updated to include preventative strategies such as vaccines, prophylaxis, and counselling. Monitoring the performance of healthcare facilities using key performance indicators is also recommended to ensure effective management and continuous improvement of vaccination programs. Patient populations in the UAE who are considered at high risk of serious disease from respiratory infections have diverse medical needs and may access healthcare across a wide range of settings and specialisms. Therefore, it is vital that all healthcare professionals across specialisms who may engage with these individuals are able to provide appropriate advice on managing the risk through vaccination, prompt testing, and treatments as needed.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"405-421"},"PeriodicalIF":3.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373577/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144668190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-06-11DOI: 10.1007/s41030-025-00301-6
Avinash Aujayeb, Philippe Astoul
In this concise article, we give a current overview of the practical approach to diagnosing pleural mesothelioma (PM). PM is a rare, incurable, aggressive cancer almost exclusively related to previous asbestos exposure. We begin by outlining the general approach to pleural malignancy. The focus then shifts to pleural mesothelioma (PM), with discussions on cytological analyses, a direct-to-thoracoscopy approach, specialist services, and future directions. This narrative review aims to provide an updated, practical overview of current and emerging diagnostic strategies.
{"title":"A Diagnostic Approach to Malignant Pleural Mesothelioma.","authors":"Avinash Aujayeb, Philippe Astoul","doi":"10.1007/s41030-025-00301-6","DOIUrl":"10.1007/s41030-025-00301-6","url":null,"abstract":"<p><p>In this concise article, we give a current overview of the practical approach to diagnosing pleural mesothelioma (PM). PM is a rare, incurable, aggressive cancer almost exclusively related to previous asbestos exposure. We begin by outlining the general approach to pleural malignancy. The focus then shifts to pleural mesothelioma (PM), with discussions on cytological analyses, a direct-to-thoracoscopy approach, specialist services, and future directions. This narrative review aims to provide an updated, practical overview of current and emerging diagnostic strategies.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"503-517"},"PeriodicalIF":3.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373620/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144267201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-07-13DOI: 10.1007/s41030-025-00306-1
Kai-Michael Beeh, Karl Scheithe, Heike Schmutzler, Saskia Krüger
Introduction: Responder analyses provide information about characteristics associated with therapeutic benefits. Short-term responses may predict long-term benefits. We evaluated responders, clinically important improvement (CII), disease stability (DS), and the relation of short- to long-term responses in patients with chronic obstructive pulmonary disease (COPD) in ELLITHE.
Methods: ELLITHE was a multicenter, open-label, non-interventional effectiveness study between 2020 and 2022 evaluating the effects of treatment initiation with once-daily single-inhaler triple therapy (odSITT) FF/UMEC/VI (100/62.5/25 µg via ELLIPTA) on COPD Assessment Test (CAT), forced expiratory volume in 1 s (FEV1), and exacerbations over 12 months. Post hoc responder analyses for CAT (≥ 2 units improvement), FEV1 (≥ 100 ml change), and exacerbations (no event) were performed. Composite endpoints CII and DS (CII = response to at least two outcomes; DS = absence of clinically important deterioration for all outcomes) were also evaluated.
Results: A total of 786 patients had available data for any analysis. At study completion, 53.3% of patients were CAT, 36.7% FEV1, and 90.2% exacerbation responders, with 22.1% responding to all outcomes; 64.3% had a CII, and 52.7% showed DS. CII and DS were more frequent in subjects with higher baseline CAT score, and DS in patients on prior ICS/LABA therapy (all p < 0.05). Early (3 months) CAT, FEV1 and CII response strongly predicted respective responses at study end (odds ratios = OR ranging from 6.3 to 7.4), and DS (OR from 3.0 to 4.2). In the patient subset with available baseline eosinophil counts, response was generally similar at < 150 versus ≥ 150 cells/μl.
Conclusions: Despite overlapping responses to single and composite outcomes with odSITT, individual patterns support a multidimensional approach to evaluate benefits in COPD. Responders had higher baseline CAT scores and frequency of prior dual therapies. Short-term responses of FEV1 and/or CAT were reasonable predictors of long-term responses, including DS. DS was achievable for the majority of patients and may represent a useful outcome for future COPD research and management.
{"title":"Clinically Important Improvements and Disease Stability with Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy in the ELLITHE Trial: A Post Hoc Responder Analysis.","authors":"Kai-Michael Beeh, Karl Scheithe, Heike Schmutzler, Saskia Krüger","doi":"10.1007/s41030-025-00306-1","DOIUrl":"10.1007/s41030-025-00306-1","url":null,"abstract":"<p><strong>Introduction: </strong>Responder analyses provide information about characteristics associated with therapeutic benefits. Short-term responses may predict long-term benefits. We evaluated responders, clinically important improvement (CII), disease stability (DS), and the relation of short- to long-term responses in patients with chronic obstructive pulmonary disease (COPD) in ELLITHE.</p><p><strong>Methods: </strong>ELLITHE was a multicenter, open-label, non-interventional effectiveness study between 2020 and 2022 evaluating the effects of treatment initiation with once-daily single-inhaler triple therapy (odSITT) FF/UMEC/VI (100/62.5/25 µg via ELLIPTA) on COPD Assessment Test (CAT), forced expiratory volume in 1 s (FEV<sub>1</sub>), and exacerbations over 12 months. Post hoc responder analyses for CAT (≥ 2 units improvement), FEV<sub>1</sub> (≥ 100 ml change), and exacerbations (no event) were performed. Composite endpoints CII and DS (CII = response to at least two outcomes; DS = absence of clinically important deterioration for all outcomes) were also evaluated.</p><p><strong>Results: </strong>A total of 786 patients had available data for any analysis. At study completion, 53.3% of patients were CAT, 36.7% FEV<sub>1</sub>, and 90.2% exacerbation responders, with 22.1% responding to all outcomes; 64.3% had a CII, and 52.7% showed DS. CII and DS were more frequent in subjects with higher baseline CAT score, and DS in patients on prior ICS/LABA therapy (all p < 0.05). Early (3 months) CAT, FEV<sub>1</sub> and CII response strongly predicted respective responses at study end (odds ratios = OR ranging from 6.3 to 7.4), and DS (OR from 3.0 to 4.2). In the patient subset with available baseline eosinophil counts, response was generally similar at < 150 versus ≥ 150 cells/μl.</p><p><strong>Conclusions: </strong>Despite overlapping responses to single and composite outcomes with odSITT, individual patterns support a multidimensional approach to evaluate benefits in COPD. Responders had higher baseline CAT scores and frequency of prior dual therapies. Short-term responses of FEV<sub>1</sub> and/or CAT were reasonable predictors of long-term responses, including DS. DS was achievable for the majority of patients and may represent a useful outcome for future COPD research and management.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"443-459"},"PeriodicalIF":3.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373607/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144619857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-09-01Epub Date: 2025-06-16DOI: 10.1007/s41030-025-00302-5
Ignacio Español Montero, Fernanda Hernandez-Gonzalez, Jacobo Sellares
The spectrum of interstitial lung diseases (ILDs) includes a wide range of clinical entities with variable disease courses and prognoses. Several ILDs other than idiopathic pulmonary fibrosis (IPF) may exhibit a progressive fibrotic phenotype, with diverse clinical presentation, histopathological and radiological patterns, as well as varying rates of disease progression and uncertain epidemiology, but with a similar prognosis of untreated idiopathic pulmonary fibrosis with irreversible lung function deterioration, substantial worsening of quality of life and early mortality. The recently defined term "progressive pulmonary fibrosis" (PPF) stands as an opportunity to better classify patients with progressive fibrotic disease and other IPF, irrespective of the underlying ILD. The definition of disease progression, including factors such as pulmonary function test decline, radiological progression, and symptomatic worsening, was not adopted until recently, thus significantly impacting the certainty of current estimates of incidence and prevalence and prognostic outcomes. Understanding disease progression in the broad spectrum of potentially progressive ILDs is key for developing standardized management algorithms irrespective of the ILD diagnosis. Current evidence points towards the potential beneficial effect of antifibrotic drugs in lung function decline and overall outcomes in several non-IPF progressive ILDs showing progression despite optimal management.
{"title":"Epidemiology and Prognosis of Progressive Pulmonary Fibrosis: A Literature Review.","authors":"Ignacio Español Montero, Fernanda Hernandez-Gonzalez, Jacobo Sellares","doi":"10.1007/s41030-025-00302-5","DOIUrl":"10.1007/s41030-025-00302-5","url":null,"abstract":"<p><p>The spectrum of interstitial lung diseases (ILDs) includes a wide range of clinical entities with variable disease courses and prognoses. Several ILDs other than idiopathic pulmonary fibrosis (IPF) may exhibit a progressive fibrotic phenotype, with diverse clinical presentation, histopathological and radiological patterns, as well as varying rates of disease progression and uncertain epidemiology, but with a similar prognosis of untreated idiopathic pulmonary fibrosis with irreversible lung function deterioration, substantial worsening of quality of life and early mortality. The recently defined term \"progressive pulmonary fibrosis\" (PPF) stands as an opportunity to better classify patients with progressive fibrotic disease and other IPF, irrespective of the underlying ILD. The definition of disease progression, including factors such as pulmonary function test decline, radiological progression, and symptomatic worsening, was not adopted until recently, thus significantly impacting the certainty of current estimates of incidence and prevalence and prognostic outcomes. Understanding disease progression in the broad spectrum of potentially progressive ILDs is key for developing standardized management algorithms irrespective of the ILD diagnosis. Current evidence points towards the potential beneficial effect of antifibrotic drugs in lung function decline and overall outcomes in several non-IPF progressive ILDs showing progression despite optimal management.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"347-363"},"PeriodicalIF":3.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373627/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144302757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2024-10-17DOI: 10.1007/s41030-024-00273-z
R Narasimhan, Sitesh Roy, Meghanadh Koralla, P K Thomas, M Ilambarathi, S Balamurugan, M Harish, R Sabarinath, Gaurav Medikeri, Partha Bose, V R Pattabhiraman, M K Rajasekar, A R Gayathri, T Dhanasekar, V Nandagopal, G Gananathan, S K Ravichandran, M N Shankar, Aniruddha Majumder, Shelley Shamim, Meenesh Juvekar, Vijay K Singh, T Mohankumar, S Prasanna Kumar, Debraj Jash, Salil Bendre, Suhail Neliyathodi, Sunil Janardanan Unnithan, Archana Karadkhele
Allergic rhinitis and asthma are commonly coexisting conditions, significantly impacting patient health and quality of life. Despite their interrelation, diagnosing allergic rhinitis in patients with asthma remains challenging, leading to underdiagnosis and suboptimal management. The expert consensus engaged a modified Delphi method involving 29 experts including pulmonologists, ear, nose, and throat surgeons, and allergologists. Through group discussions, consensus statements were developed regarding the epidemiology, diagnosis, and management of allergic rhinitis and asthma. Final consensus statements were formulated based on the experts' collective clinical judgment and experience. This expert consensus provides updated recommendations tailored to the Indian context, addressing the gaps in existing research and clinical practice. By promoting a systematic and evidence-based approach to diagnosis and management, this consensus aims to support clinicians in effectively identifying and treating allergic rhinitis in patients with asthma, thereby improving overall disease management and patient well-being.
{"title":"Expert Panel Consensus Recommendations for Allergic Rhinitis in Patients with Asthma in India.","authors":"R Narasimhan, Sitesh Roy, Meghanadh Koralla, P K Thomas, M Ilambarathi, S Balamurugan, M Harish, R Sabarinath, Gaurav Medikeri, Partha Bose, V R Pattabhiraman, M K Rajasekar, A R Gayathri, T Dhanasekar, V Nandagopal, G Gananathan, S K Ravichandran, M N Shankar, Aniruddha Majumder, Shelley Shamim, Meenesh Juvekar, Vijay K Singh, T Mohankumar, S Prasanna Kumar, Debraj Jash, Salil Bendre, Suhail Neliyathodi, Sunil Janardanan Unnithan, Archana Karadkhele","doi":"10.1007/s41030-024-00273-z","DOIUrl":"10.1007/s41030-024-00273-z","url":null,"abstract":"<p><p>Allergic rhinitis and asthma are commonly coexisting conditions, significantly impacting patient health and quality of life. Despite their interrelation, diagnosing allergic rhinitis in patients with asthma remains challenging, leading to underdiagnosis and suboptimal management. The expert consensus engaged a modified Delphi method involving 29 experts including pulmonologists, ear, nose, and throat surgeons, and allergologists. Through group discussions, consensus statements were developed regarding the epidemiology, diagnosis, and management of allergic rhinitis and asthma. Final consensus statements were formulated based on the experts' collective clinical judgment and experience. This expert consensus provides updated recommendations tailored to the Indian context, addressing the gaps in existing research and clinical practice. By promoting a systematic and evidence-based approach to diagnosis and management, this consensus aims to support clinicians in effectively identifying and treating allergic rhinitis in patients with asthma, thereby improving overall disease management and patient well-being.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"129-155"},"PeriodicalIF":2.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12102437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142473399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2025-04-08DOI: 10.1007/s41030-025-00293-3
Charles L Daley, James D Chalmers, Patrick A Flume, David E Griffith, Naoki Hasegawa, Kozo Morimoto, Kevin L Winthrop, Chau-Chyun Sheu, Korkut Avsar, Dario Andrisani, Luigi Ruffo Codecasa, Dayton W Yuen, Mariam Hassan, Marie-Laure Nevoret, Kevin Mange
Introduction: ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life-Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent Mycobacterium avium complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE.
Methods: Adult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires.
Results: Of 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0.
Conclusions: Patients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains.
Clinicaltrials:
Gov identifier: NCT04677543.
ARISE是一项全球临床试验,旨在提供证据,证明患者报告的结局仪器——生活质量——支气管扩张(QOL-B)[仅限呼吸域(RD)]和患者报告的结局测量信息系统简表v1.0-疲劳7a (PROMIS F SF-7a)在新诊断或复发的禽分枝杆菌复杂肺病(MACLD)患者中的效用。在这里,我们描述了临床试验行为、患者特征和患者报告的基线症状。方法:纳入未对当前MAC感染进行抗生素治疗的新诊断或复发的非腔型MACLD成年患者;在筛查期间收集包括合并症和MACLD病史在内的数据。采用QOL-B、PROMIS F SF-7a和慢性疾病治疗功能评估(FACIT)问卷对症状负担进行评估。结果:来自12个国家的99例患者纳入了ARISE,中位年龄为69.0岁;以白人(80.8%)和女性(77.8%)居多。这是72.7%的患者首次诊断为MACLD。患者经常报告合并呼吸系统疾病:支气管扩张(49.5%)、哮喘(21.2%)和慢性阻塞性肺疾病(16.2%)。基线时,平均(±SD)和中位QOL-B RD评分分别为65.0(±15.3)和66.7;PROMIS F SF-7a t评分分别为53.8(±8.2)和55.1;FACIT-Fatigue评分分别为35.0(±9.6)和37.0。结论:ARISE的患者代表了现实世界的MACLD患者群体。合并慢性呼吸系统疾病在新发或复发的MACLD患者中很常见,当医生开始MACLD治疗时,大量的疾病负担可以通过疲劳和QOL-B域的测量值来证明。临床试验:政府标识符:NCT04677543。
{"title":"Trial Conduct, Baseline Characteristics, and Symptom Burden of Patients in the ARISE Study.","authors":"Charles L Daley, James D Chalmers, Patrick A Flume, David E Griffith, Naoki Hasegawa, Kozo Morimoto, Kevin L Winthrop, Chau-Chyun Sheu, Korkut Avsar, Dario Andrisani, Luigi Ruffo Codecasa, Dayton W Yuen, Mariam Hassan, Marie-Laure Nevoret, Kevin Mange","doi":"10.1007/s41030-025-00293-3","DOIUrl":"10.1007/s41030-025-00293-3","url":null,"abstract":"<p><strong>Introduction: </strong>ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life-Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent Mycobacterium avium complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE.</p><p><strong>Methods: </strong>Adult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires.</p><p><strong>Results: </strong>Of 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0.</p><p><strong>Conclusions: </strong>Patients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov identifier: </strong>NCT04677543.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"269-283"},"PeriodicalIF":2.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12102049/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143812168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2025-03-20DOI: 10.1007/s41030-025-00292-4
Caroline Reilly, Antonios Stavropoulos-Kalinoglou, Daniel Peckham, Ian J Clifton, Oliver J Price
Introduction: Asthma is a complex airways disease that affects over 350-million people worldwide. It is estimated that up to 10% of adults and 2.5% of children with asthma have severe disease, which is associated with reduced physical activity. The introduction of biological therapies has revolutionised the management of severe asthma; however, it remains to be determined whether this translates into improvements in physical activity status.
Method: This 1-year retrospective study evaluated step-based physical activity (via a smartphone pedometer) in adults with severe asthma (n = 20) and two matched sub-groups (n = 20 mild asthma and n = 20 healthy controls).
Results: The annual daily step count was significantly less in adults with severe asthma (4698 ± 1927) versus mild asthma (7239 ± 1815) (P = 0.009) and healthy controls (8252 ± 2115) (P = 0.001). No difference in physical activity was observed between those with mild asthma and healthy controls (P > 0.05).
Conclusion: Despite long-term treatment with biological therapies, physical activity remains significantly lower in adults with severe asthma. The development of personalised evidence-based interventions to promote physical activity in people with severe asthma remains a priority.
{"title":"Physical Activity in Adults with Severe Asthma On-Treatment with Biological Therapies: A 1-Year Retrospective Analysis of Real-World Data.","authors":"Caroline Reilly, Antonios Stavropoulos-Kalinoglou, Daniel Peckham, Ian J Clifton, Oliver J Price","doi":"10.1007/s41030-025-00292-4","DOIUrl":"10.1007/s41030-025-00292-4","url":null,"abstract":"<p><strong>Introduction: </strong>Asthma is a complex airways disease that affects over 350-million people worldwide. It is estimated that up to 10% of adults and 2.5% of children with asthma have severe disease, which is associated with reduced physical activity. The introduction of biological therapies has revolutionised the management of severe asthma; however, it remains to be determined whether this translates into improvements in physical activity status.</p><p><strong>Method: </strong>This 1-year retrospective study evaluated step-based physical activity (via a smartphone pedometer) in adults with severe asthma (n = 20) and two matched sub-groups (n = 20 mild asthma and n = 20 healthy controls).</p><p><strong>Results: </strong>The annual daily step count was significantly less in adults with severe asthma (4698 ± 1927) versus mild asthma (7239 ± 1815) (P = 0.009) and healthy controls (8252 ± 2115) (P = 0.001). No difference in physical activity was observed between those with mild asthma and healthy controls (P > 0.05).</p><p><strong>Conclusion: </strong>Despite long-term treatment with biological therapies, physical activity remains significantly lower in adults with severe asthma. The development of personalised evidence-based interventions to promote physical activity in people with severe asthma remains a priority.</p>","PeriodicalId":20919,"journal":{"name":"Pulmonary Therapy","volume":" ","pages":"307-313"},"PeriodicalIF":2.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12102443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143670912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}