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Muco-active Agent Use and Clinical Outcomes After Lung Cancer Diagnosis in Chronic Obstructive Pulmonary Disease
Sponsor: Seoul National University
Summary
The Target Trial Emulation of Muco-active Agent Use and Clinical Outcomes After Lung Cancer Diagnosis Among Patients With Chronic Obstructive Pulmonary Disease (TAME-CLC) study is a retrospective observational cohort study using existing real-world data from the Korean Cancer Data Center (K-CURE) database to evaluate whether use of muco-active agents is associated with clinical outcomes after lung cancer diagnosis among adults with chronic obstructive pulmonary disease (COPD) and localized-stage lung cancer. The investigators will not assign any treatment or medication. Instead, the study will emulate a hypothetical target trial using routinely collected retrospective data. Eligible patients will be adults aged 40 to less than 80 years who have COPD before lung cancer diagnosis and meet prespecified diagnostic and treatment-based criteria. Patients will be classified according to muco-active agent treatment strategies based on prescription records after the first lung cancer diagnosis. The emulated treatment strategy is use of any muco-active agent within a prespecified grace period after lung cancer diagnosis. The comparator strategy is no muco-active agent use during the same grace period. Muco-active agents include mucolytics, mucoregulators, expectorants, and mucokinetics, such as N-acetylcysteine, erdosteine, carbocysteine, guaifenesin, ivy-leaf extract, ambroxol, and bromhexine. The primary outcome is time to moderate-to-severe COPD exacerbation after lung cancer diagnosis. Secondary outcomes include all-cause mortality, cancer-related mortality, and respiratory disease-related mortality. A clone-censoring-weighting approach will be used within a target trial emulation framework to estimate the modified intention-to-treat effect of muco-active agent use while adjusting for measured baseline differences between treatment strategies.
Official title: The Target Trial Emulation of Muco-active Agent Use and Clinical Outcomes After Lung Cancer Diagnosis Among Patients With Chronic Obstructive Pulmonary Disease (TAME-CLC)
Key Details
Gender
All
Age Range
40 Years - 79 Years
Study Type
OBSERVATIONAL
Enrollment
27000
Start Date
2026-06-01
Completion Date
2027-06-30
Last Updated
2026-07-21
Healthy Volunteers
No
Interventions
Muco-active agents
Exposure is defined as initiation of any prespecified muco-active agent during the 4-week grace period, with alternative 2-, 6-, and 8-week grace periods evaluated in sensitivity analyses, after the first diagnosis of localized-stage lung cancer. Drug exposure will be identified using prescription records from the Korean Cancer Data Center (K-CURE) database. Patients receiving muco-active agents during the 12-week washout period before lung cancer diagnosis will be excluded to emulate a new-user target trial. Exposure classification follows the predefined treatment strategies specified in the target trial protocol.
No muco-active agent use
Comparator exposure strategy defined as no prescription, medication order, or dispensing record for a prespecified muco-active agent during the exposure assessment window after the index date.
Locations (2)
National Cancer Center,
Goyang-si, Gyeonggi-do, South Korea
Seoul National University College of Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, Select..., South Korea