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Methods: Cohort study emulating a randomized trial in UK patients aged ≥40, using fine-stratification propensity-score weighting and Cox models with a 30-day grace period. Results: 876 vs 5010 starters; adjusted incidence 5.6 vs 2.9 per 100 person-years; HR 1.96 (95% CI 1.01–3.77). Conclusions: ICS-containing triple therapy may increase severe COVID-19 risk pre-vaccine era; findings should inform treatment initiation.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/risk-of-hospitalized-covid-19-in-copd-single-inhaler-triple-versus-dual-bronchodilator-therapy/433333/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/risk-of-hospitalized-covid-19-in-copd-single-inhaler-triple-versus-dual-bronchodilator-therapy/433333.png","ImageObject",300,407,{"name":92,"@type":93},"LangkahRina","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-31","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":52},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What comparison does the study make in COPD patients?","Question",{"text":112,"@type":113},"It compares initiation of a single-inhaler triple therapy (ICS-LABA-LAMA) with initiation of a single-inhaler dual bronchodilator therapy (LABA-LAMA).","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What did the study find about hospitalized severe COVID-19 risk?",{"text":117,"@type":113},"Patients starting the triple inhaler had a higher risk of hospitalized severe COVID-19, with an adjusted hazard ratio of 1.96 (95% CI 1.01–3.77).",{"name":119,"@type":110,"acceptedAnswer":120},"Why is the timing before COVID-19 vaccine rollout important?",{"text":121,"@type":113},"The study targets the pre-vaccine period to estimate risks associated with treatment initiation prior to vaccine effects, focusing on potential exposure patterns in 2020.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},433333,1790958205,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":52,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":24,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144,"preview_page_count":4},962090893776,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Pharmacoepidemiology and Drug Safety   \nRisk of Hospitalized COVID-19 in COPD: Single-Inhaler Triple Versus Dual Bronchodilator Therapy  \nSimon Galmiche1,2 | Sophie Dell'Aniello1 | Samy Suissa1,2   \n1Center for Clinical Epidemiology, Lady Davis Institute (LDI), Jewish General Hospital, Montreal, Canada | 2Department of Epidemiology, Biostatistics and  \nOccupational Health, McGill University, Montreal, Canada Correspondence: Samy Suissa ([samy.suissa@mcgill.ca](samy.suissa@mcgill.ca))  \nReceived: 5 September 2025 | Revised: 24 November 2025 | Accepted: 20 December 2025  \nKeywords: drug safety | infection | inhaled corticosteroids | new-user cohort  \nABSTRACT  \nPurpose: Our objective was to estimate the effect of initiating an inhaled corticosteroids-containing single-inhaler triple agent (ICS-LABA-LAMA) compared with a single-inhaler LABA-LAMA dual bronchodilator in patients with COPD on the risk of severe COVID-19 prior to the roll-out of vaccines.  \nMethods: We conducted a cohort study emulating a randomized trial, among patients with COPD aged 40years or more in the UK, comparing those who initiated a triple inhaler with those who initiated a dual bronchodilator inhaler between March 1 and December 31, 2020. Weighting by fine stratification of the propensity score was used to account for confounders. The risk of hospitalized COVID-19 was compared with a Cox proportional hazards model in an as-treated analysis with a 30-day grace period. Results: The study cohort included 876 patients initiating a triple inhaler and 5010 initiating a dual LABA-LAMA inhaler. The adjusted incidence rate of hospitalized COVID-19 was 5.6 per 100 person-years in the triple inhaler group and 2.9 per 100 personyears in the dual inhaler group, with a corresponding hazard ratio (HR) of 1.96 (95% confidence interval 1.01–3.77) . Sensitivity analyses on the duration of the grace period, using an intent-to-treat exposure classification, or starting follow-up 14 days after treatment initiation (accounting for treatment initiation for an undocumented SARS-CoV-2 infection) were generally consistent with the main analysis.  \nConclusions: Patients with COPD prescribed an ICS-containing triple inhaler were potentially exposed to an increased risk of severe COVID-19 prior to the vaccine era. As SARS-CoV-2 continues to cause significant burden, these findings should be considered when determining initiation of inhaled treatment in COPD.  \n1 | Purpose  \nTriple therapy for patients with chronic obstructive pulmonary disease (COPD), combining inhaled corticosteroids (ICS) with long-acting β2-agonists (LABA) and long-acting muscarinic antagonists (LAMA) is recommended for patients with exacerbations and high blood eosinophil count (≥300/μL) [1], or those with high disease burden despite dual LABA-LAMA therapy [2] . Along with the documented benefit of ICS-based triple therapy on the risk of exacerbation in patients with multiple  \nexacerbations, it is also associated with an increased risk of pneumonia [3, 4], potentially due to impairments of interferon responses [5] .  \nThe effect of ICS-based triple inhaled therapy on the risk of severe COVID-19, however, remains uncertain, with several observational studies that produced discrepant findings [6–9] . These studies investigated ICS use but all included prevalent users of ICS, and some studied a mix of respiratory diseases and inhaled co-medications [6–10] . We therefore employed a  \nThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.  \n© 2026 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.  \nPharmacoepidemiology and Drug Safety, 2026; 35:e70321 1 of 5  \n[https://doi.org/10.1002/pds.70321](https://doi.org/10.1002/pds.70321)  \n\n| Key Points\u003Cbr>• The impact of inhaled corticoste","cbCaidPRwxilQXlU","https://ap.wps.com/l/cbCaidPRwxilQXlU","pdf",243634,"English","# Abstract\n## Purpose\n## Methods\n## Results\n## Conclusions\n# Key Points\n# Plain Language Summary","[{\"question\":\"What comparison does the study make in COPD patients?\",\"answer\":\"It compares initiation of a single-inhaler triple therapy (ICS-LABA-LAMA) with initiation of a single-inhaler dual bronchodilator therapy (LABA-LAMA).\"},{\"question\":\"What did the study find about hospitalized severe COVID-19 risk?\",\"answer\":\"Patients starting the triple inhaler had a higher risk of hospitalized severe COVID-19, with an adjusted hazard ratio of 1.96 (95% CI 1.01–3.77).\"},{\"question\":\"Why is the timing before COVID-19 vaccine rollout important?\",\"answer\":\"The study targets the pre-vaccine period to estimate risks associated with treatment initiation prior to vaccine effects, focusing on potential exposure patterns in 2020.\"}]","Risk of Hospitalized COVID-19 in COPD - Single-Inhaler Triple Versus Dual Bronchodilator Therapy | PDF",1790663664,13]