BMJ Open Respiratory Research最新文献

{"title":"Phase 2 study design and analysis approach for BBT-877: an autotaxin inhibitor targeting idiopathic pulmonary fibrosis.","authors":"Toby Maher, Jin Woo Song, Mordechai Reuven Kramer, Lisa Lancaster, Tamera J Corte, Jeong Yun, KyungJin Kim, Jimin Cho, Luisa Fernanda Sather, Peter M George, Anand Devaraj, Jin Hyuk Jung, Sujin Jung","doi":"10.1136/bmjresp-2024-003038","DOIUrl":"10.1136/bmjresp-2024-003038","url":null,"abstract":"<p><strong>Introduction: </strong>Proof-of-concept (POC) studies are vital in determining the feasibility of further drug development, primarily by assessing preliminary efficacy signals with credible endpoints. However, traditional POC studies in idiopathic pulmonary fibrosis (IPF) can suffer from low credibility due to small sample sizes and short durations, leading to non-replicable results in larger phase III trials. To address this, we are conducting a 24-week POC study with 120 patients with IPF, using a statistically supported sample size and incorporating exploratory CT-based imaging biomarkers, to support decision-making in the case of non-significant primary endpoint results. This approach aims to provide data to enable a robust decision-making process for advancing clinical development of BBT-877.</p><p><strong>Methods and analysis: </strong>In this phase II, double-blind, placebo-controlled study, approximately 120 patients with IPF will be randomised in a 1:1 ratio to receive placebo or 200 mg of BBT-877 two times per day over 24 weeks, with stratification according to background use of an antifibrotic treatment (pirfenidone background therapy, nintedanib background therapy or no background therapy). The primary endpoint is absolute change in forced vital capacity (FVC) (mL) from baseline to week 24. Key secondary endpoints include change from baseline to week 24 in %-predicted FVC, diffusing capacity of the lung for carbon monoxide, 6 min walk test, patient-reported outcomes, pharmacokinetics and safety, and tolerability. Key exploratory endpoints include eLung-based CT evaluation and biomarker-based assessment of pharmacodynamics.</p><p><strong>Ethics and dissemination: </strong>This study is being conducted following the Declaration of Helsinki principles, Good Clinical Practice guidance, applicable local regulations and local ethics committees. An independent data monitoring committee unblinded to individual subject treatment allocation will evaluate safety and efficacy data on a regular basis throughout the study. The results of this study will be presented at scientific conferences and peer-review publications.</p><p><strong>Trial registration number: </strong>NCT05483907.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12097056/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Novel multimodal intervention for surgical prehabilitation on functional recovery and muscle characteristics in patients with non-small cell lung cancer: study protocol for a randomised controlled trial (MMP-LUNG).","authors":"Audrey Moyen, Chloé Fleurent-Grégoire, Chelsia Gillis, Roni Zaks, Francesco Carli, Celena Scheede-Bergdahl, Jonathan Spicer, Jonathan Cools-Lartigue, Sara Najmeh, José A Morais, Vera Mazurak, Stéphanie Chevalier","doi":"10.1136/bmjresp-2024-002884","DOIUrl":"10.1136/bmjresp-2024-002884","url":null,"abstract":"<p><strong>Introduction: </strong>Lung cancer is the leading cause of cancer-related deaths. Patients with stage I-III non-small cell lung cancer (NSCLC) are candidates for surgical resection; however, patients with low muscle mass, myosteatosis, malnutrition or reduced functional capacity preoperatively have a higher risk of postoperative morbidity. Prehabilitation is a care process aiming to enhance functional capacity before surgery to improve surgical outcomes. Study objectives are to test the effect of prehabilitation interventions of a mixed-nutrient supplement (NUT) alone or its combination with exercise (MM, multimodal prehabilitation), compared with placebo-control (CTL), in NSCLC patients on change in functional capacity pre-surgery and post-discharge, muscle mass and myosteatosis, postoperative health-related quality of life (HRQoL), complications and length of hospital stay. We hypothesise that a multi-nutrient supplement, with or without exercise, will be of benefit.</p><p><strong>Methods and analysis: </strong>Randomised controlled trial of three parallel arms: 168 patients with operable NSCLC at nutritional risk are randomised 1:1:1 to CTL, NUT or MM. Patients in the NUT and MM groups receive a nutritional supplement consisting of whey protein, leucine, vitamin D and fish oil 4-6 weeks preoperatively and 6 weeks post-discharge. The exercise programme (MM) consists of daily moderate-intensity aerobic activity and resistance training 3 days/week. The following is assessed at baseline, preoperatively and week six post-discharge: functional capacity using the 6 min walk test, muscle mass and myosteatosis using D3-creatine dilution and peripheral quantitative CT, and HRQoL using the Functional Assessment of Cancer Therapy-Lung. Intention-to-treat analysis of covariance will compare between-group differences adjusted for baseline variables. Postoperative functional recovery will be tested by logistic regression. Between-group differences in clinical outcomes will be tested, applying Bonferroni correction.</p><p><strong>Ethics and dissemination: </strong>This trial is approved by the McGill University Health Centre Research Ethics Board (2022-7782). Results will be published in open-access peer-reviewed journals and conference presentations.</p><p><strong>Trial registration details: </strong>NCT05955248.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12097010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic role of serum CA-125 and CA19-9 in lung transplant candidates with interstitial lung disease: a retrospective cohort study.","authors":"Shimon Izhakian, Meir Gagula, Haya Engelstein, Liel Malka, Lev Freidkin, Dror Rosengarten, Mordechai Reuven Kramer","doi":"10.1136/bmjresp-2024-002614","DOIUrl":"10.1136/bmjresp-2024-002614","url":null,"abstract":"<p><strong>Background: </strong>Advanced interstitial lung disease (ILD) often necessitates lung transplantation, and identifying accessible prognostic markers is essential for effective management. However, the link between serum tumour markers and survival in waitlisted lung transplant candidates with advanced ILD remains underexplored.</p><p><strong>Objective: </strong>To evaluate associations between serum tumour marker levels and long-term survival in lung transplant candidates with advanced ILD.</p><p><strong>Methods: </strong>This study included 282 patients with end-stage ILD who were waitlisted for lung transplantation from November 2012 to March 2021. Baseline data and serum tumour marker levels were assessed before listing. Vital status and transplant outcomes were retrospectively reviewed as of 31 May 2023. Associations between tumour markers, clinical variables and mortality were analysed using Cox proportional hazards models with competing risk regression.</p><p><strong>Results: </strong>During a median wait time of 17.8 months (IQR: 7.8-44.1), 107 patients received transplants, 38 survived on the list and 137 died while waiting. Multivariable analysis identified higher CA-125 levels (HR 1.03, 95% CI 1.01 to 1.06, p=0.001), older age (HR 1.03, 95% CI 1.01 to 1.06, p=0.001), female gender (HR 1.43, 95% CI 1.01 to 2.04, p<0.04), elevated C-reactive protein (HR 1.17, 95% CI 1.03 to 1.34, p=0.01) and cerebrovascular disease (HR 2.03, 95% CI 1.38 to 2.98, p=0.01) as significant predictors of mortality.</p><p><strong>Conclusion: </strong>Among waitlisted lung transplant candidates with advanced ILD, elevated serum carbohydrate antigen (CA)-125 and CA19-9 levels are associated with higher mortality risk. Routine assessment of these markers may enhance risk stratification for this patient population.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12097092/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between inhaled corticosteroids and incidence of idiopathic pulmonary fibrosis: nationwide population-based study.","authors":"Hyewon Lee, Hee-Young Yoon","doi":"10.1136/bmjresp-2024-002566","DOIUrl":"10.1136/bmjresp-2024-002566","url":null,"abstract":"<p><strong>Background: </strong>Idiopathic pulmonary fibrosis (IPF) is a progressive disease found primarily in older people, with the use of systemic steroids linked to poor outcomes. However, the role of inhaled corticosteroids (ICSs) in IPF remains unclear. This study investigated the association between ICS use and IPF risk using national insurance data, particularly in individuals with chronic airway diseases.</p><p><strong>Methods: </strong>Using the National Health Insurance Service-National Sample Cohort database, our study included patients diagnosed with chronic obstructive pulmonary disease or asthma. ICS exposure was assessed via treatment claims, and IPF cases were identified using broad and narrow criteria. We used inverse probability of treatment weighting (IPTW) with propensity scores for balanced covariate analysis.</p><p><strong>Results: </strong>Of 57 456 patients (mean age: 55.9 years, 42.3% men), 16.5% used ICS and 83.5% did not. ICS users showed higher rates of broad (0.98 vs 0.41 per 1000) and narrow IPF (0.61 vs 0.21 per 1000) than non-users. Pre-IPTW, ICS use was associated with increased IPF risk; however, this was not significant post-IPTW. Post-IPTW, both ICS dose as a continuous variable (broad adjusted HR per 100 µg/day: 1.03, 95% CI: 1.02 to 1.04; narrow adjusted HR per 100 µg/day: 1.03, 95% CI: 1.01 to 1.04 post-IPTW) and high-dose ICS (≥1000 µg/day) (broad adjusted HR: 3.89, 95% CI: 1.61 to 9.41; narrow adjusted HR: 3.99, 95% CI: 1.19 to 13.41) use correlated with an elevated IPF risk.</p><p><strong>Conclusion: </strong>While no overall significant association between ICS use and IPF risk was observed post-IPTW, there may be an increased risk in patients using high-dose ICS.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12097008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acceptability of pulmonary rehabilitation in Malawi: a qualitative study.","authors":"Fanuel Meckson Bickton, Talumba Mankhokwe, Beatrice Chavula, Emily Chitedze, Martha Manda, Cashon Fombe, Martha Mitengo, Langsfield Mwahimba, Moses Isiagi, Richard N van Zyl-Smit, Susan Hanekom, Martin Heine, Harriet Shannon, Jamie Rylance, Enock Chisati, Stephen B Gordon, Felix Limbani","doi":"10.1136/bmjresp-2024-002547","DOIUrl":"10.1136/bmjresp-2024-002547","url":null,"abstract":"<p><strong>Background: </strong>Pulmonary rehabilitation (PR) is an effective non-pharmacological intervention for people with chronic respiratory diseases (CRDs), but its acceptability in Malawi was unknown.</p><p><strong>Objectives: </strong>To explore patients' acceptability of PR at Queen Elizabeth Central Hospital, Blantyre, Malawi.</p><p><strong>Methods: </strong>This was a pre-post cohort study where participants were offered a two times per week hospital-based PR programme for 6 weeks, consisting of endurance and strengthening exercises. Following programme completion, face-to-face semistructured in-depth interviews with the participants were conducted. Interview transcripts were thematically analysed using a deductive approach.</p><p><strong>Results: </strong>10 adults (five females and five males) out of 14 invited (~70% uptake) participated in the PR programme and subsequent in-depth interviews. Five key themes emerged: (1) debilitating symptom experience of CRD prior to PR; (2) positive impact of PR on living with CRD; (3) contextual programme design improved participants' experience with PR; (4) one size does not fit all and (5) challenges and opportunities for home-based PR. Participants reported experiencing improvements in physical, psychological and social health associated with PR programme participation. The provision of transport was considered a key facilitator for PR programme completion. Realising the gained PR benefits, participants were willing to continue exercising at their homes.</p><p><strong>Conclusion: </strong>The PR programme improved the participants' perceived health status and was well-accepted. Addressing barriers related to transport facilitated immediate implementation while providing a challenge for the scaling and sustainability of PR beyond the project duration. These findings support the drive for shifting chronic care, including rehabilitation, towards primary care and community.</p><p><strong>Trial registration number: </strong>Prospective; 27 August 2021; ISRCTN13836793.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12096972/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144126382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishing normative physiological values among breastfeeding infants in Malawi for the development of a pneumonia dysphagia risk score.","authors":"Nadia E Hoekstra, Holly Schuh, Maganizo Chagomerana, Panayiota Senekkis-Florent, Claire Pedersen, Tisungane Mvalo, Maureen A Lefton-Greif, Eric D McCollum","doi":"10.1136/bmjresp-2024-002612","DOIUrl":"10.1136/bmjresp-2024-002612","url":null,"abstract":"<p><strong>Background: </strong>Pneumonia is the leading infectious cause of death in children under 5 years of age in low- and middle-income countries (LMICs), with most deaths among infants. In children with pneumonia, aspiration events have been implicated in fatalities; however, physiological data on normative infant feeding patterns and validated techniques for detecting dysphagia and aspiration risk in LMICs are lacking. We aimed to establish a baseline of normative physiological and behavioural feeding-related variables in healthy, well, breastfeeding infants in Malawi to begin developing dysphagia risk scoring tools for infants with severe pneumonia.</p><p><strong>Methods: </strong>We enrolled healthy breastfeeding infants (<12 months) without known dysphagia risk factors who presented to a vaccination clinic in Lilongwe, Malawi. We incorporated key variables from the literature and expert opinion to create a feeding evaluation protocol. We collected sociodemographic and clinical information and evaluated infants during 5 minutes of breastfeeding. Descriptive statistics and distributions of feeding variables were used to develop two dysphagia risk scoring tools for predicting wet breath sounds during feeding, a proxy for increased aspiration risk. We assessed initial tool performance by calculating test statistics.</p><p><strong>Results: </strong>We enrolled 100 infants and analysed data from 95 healthy, well participants. The median age was 4 months (IQR 1-6) and 60% (57/95) were female. During feeding, 55% (52/95) had more than one wet breath sound and 17% (16/95) had more than one cough. The two scoring tools classified 2.1% (2/95) and 3.2% (3/95) of participants as 'at risk' for dysphagia. The specificity of each scoring tool was 100% in detecting wet breath sounds during feeding.</p><p><strong>Conclusion: </strong>We demonstrated that healthy, well Malawian infants exhibit variable vital signs and feeding behaviours during breastfeeding, and these data can be used to develop dysphagia risk scoring tools. Our next steps include evaluating and refining the tools to predict wet breath sounds in infants with severe pneumonia.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12090874/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144101061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of stability of the GOLD and STAR lung function classification for chronic obstructive pulmonary disease.","authors":"I-Lin Tsai, Chang Ting-Chia, Tang-Hsiu Huang, Chen Chang-Wen, Tzuen-Ren Hsiue, Yu Tsung, Chin-Wei Kuo","doi":"10.1136/bmjresp-2024-002830","DOIUrl":"10.1136/bmjresp-2024-002830","url":null,"abstract":"<p><strong>Background: </strong>The diagnosis of chronic obstructive pulmonary disease (COPD) typically relies on spirometric measurements. The Staging of Airflow Obstruction by Ratio (STAR) classification, a newly proposed system for grading the severity of pulmonary function, has been suggested as a potentially better predictor of outcomes than other classifications. However, the long-term stability of the STAR classification, especially in comparison to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification, remains unclear.</p><p><strong>Methods: </strong>In this retrospective cohort study, we analysed data from 622 patients with COPD, enrolled in a pay-for-performance programme at two university hospitals in Taiwan. Patients were classified according to the GOLD and STAR classifications, based on post-bronchodilator spirometry results. The study assessed the agreement between these classifications and the stability of each over a 3-year period, categorising patients into four patterns: no change (stable stage throughout), progression (persistent shift to severe stage), instability (fluctuating between higher and lower stages) and reversal (sustained improvement to a less severe stage).</p><p><strong>Results: </strong>The STAR classification system identified a higher proportion of patients with instability or reversal patterns (42.1%) compared with the GOLD classification (31.0%). While fair coherence was noted between the two classifications over 3 years, the STAR classification demonstrated greater variability. Compared with the GOLD classification, the STAR classification exhibited a higher proportion of instability or reversal patterns in stage 2 but a lower proportion of these patterns in stage 4.</p><p><strong>Conclusion: </strong>Compared with the GOLD classification, the STAR classification demonstrated higher instability and reversal patterns, suggesting the need for careful consideration for its use in long-term COPD management. Further research is required to explore the clinical implications of these findings and to refine the use of these classifications.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimal dose of maintenance steroid therapy for relapse of chronic eosinophilic pneumonia: a multicentre retrospective study.","authors":"Kenichiro Atsumi, Shunichi Nishima, Toru Tanaka, Koichiro Kamio, Namiko Taniuchi, Yoshinobu Saito, Masamitsu Shimizu, Tetsuya Okano, Masahiro Seike, Takashi Hirose","doi":"10.1136/bmjresp-2024-002697","DOIUrl":"10.1136/bmjresp-2024-002697","url":null,"abstract":"<p><strong>Background: </strong>Long-term maintenance steroid therapy (MST) is often necessary for repeated relapses of chronic eosinophilic pneumonia (CEP). Because relapse does not indicate a worse prognosis, determining the optimal steroid dose to avoid overtreatment presents a clinical challenge. Our primary objective was to evaluate the optimal MST dose to prevent repeated relapses, and the secondary objectives included identifying serum eosinophil count at relapse and background factors of relapse.</p><p><strong>Methods: </strong>A multicentre retrospective study was conducted on patients with steroid-treated CEP. Background characteristics were compared between the non-relapse and relapse groups. The optimal MST dose was determined based on dose at relapse and the final relapse prevention dose. Additionally, serum eosinophil count at relapse was assessed.</p><p><strong>Results: </strong>A total of 79 patients were included, with 44 in the non-relapse group and 35 in the relapse group. The prednisolone doses required to achieve relapse-free rates of 50% (ED₅₀) were 7.2 mg (95% CI, 4.6 to 23.6). The median serum eosinophil count at relapse was 1125 /µL (IQR, 735-2108). No clinically significant background factors were identified between the non-relapse and relapse groups.</p><p><strong>Conclusion: </strong>Our study demonstrated that a prednisolone dose of 7.2 mg achieved a 50% relapse-free rate in the relapse group. Based on these findings, we encourage clinicians to evaluate individual minimum effective steroid doses.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086887/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ending nuclear weapons, before they end us.","authors":"Chris Zielinski","doi":"10.1136/bmjresp-2025-003434","DOIUrl":"10.1136/bmjresp-2025-003434","url":null,"abstract":"","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144075667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVID-19 severity and risk of SARS-CoV-2-associated asthma exacerbation by time since booster vaccination: a longitudinal analysis of data from the COVIDENCE UK study.","authors":"Giulia Vivaldi, Mohammad Talaei, Paul E Pfeffer, Seif O Shaheen, Adrian R Martineau","doi":"10.1136/bmjresp-2025-003158","DOIUrl":"10.1136/bmjresp-2025-003158","url":null,"abstract":"<p><strong>Background: </strong>COVID-19 booster vaccinations are offered annually to priority groups, but many people have not been vaccinated in over a year. We therefore assessed the association between time since booster vaccination and breakthrough infection characteristics. We also explored whether incident COVID-19 associates with asthma exacerbations in boosted individuals with asthma and if the risk of COVID-19-associated exacerbation is affected by time since vaccination.</p><p><strong>Methods: </strong>COVIDENCE UK is a prospective, longitudinal, population-based study of COVID-19. We included adult participants who had received ≥1 booster vaccination. Time since vaccination was binarised at 6 or 12 months according to vaccine eligibility subgroup. We used regression models to obtain adjusted estimates for the association between time since vaccination and breakthrough infection severity (requiring bedrest vs milder symptoms), symptom duration, and impact on health-related quality of life (EQ-5D-3L Index). We then assessed the association of incident COVID-19 with asthma exacerbations using multilevel mixed models, by time since vaccination.</p><p><strong>Results: </strong>7391 boosted participants reported at least one breakthrough infection. Across all eligibility subgroups, greater time since vaccination associated with increased odds of severe symptoms (ORs ranging from 1.31 (95% CI 1.06 to 1.62) to 1.61 (1.29 to 2.01)). Not receiving a booster vaccination in the previous 12 months was associated with longer time to recovery overall (HR for recovery 0.90, 95% CI 0.81 to 0.99), but evidence for vaccination subgroups was weak. Greater time since vaccination was associated with a small decrease in EQ-5D-3L Index overall (-0.02, 95% CI -0.03 to -0.00) and among participants younger than 75 years, but did not reach our estimates for a minimum clinically important difference. Among 2100 participants with asthma, incident COVID-‍19 associated with increased risk of asthma exacerbation, both within 12 months of vaccination (OR 5.11 (95% CI 4.19 to 6.24)) and later (5.60 (2.98 to 10.53)), with a greater difference in point estimates when considering severe exacerbations (6.59 (4.70 to 9.22) vs 9.20 (3.56 to 23.78)).</p><p><strong>Conclusion: </strong>Longer time since booster vaccination consistently associates with more severe infections and may increase the risk of severe asthma exacerbations in people with asthma. These findings highlight the importance of ensuring those currently eligible receive their boosters, and the need for research on further vaccinations in people with asthma no longer eligible for boosters.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085896","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}