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The Time-based Register and Analysis of COPD Endpoints (TRACE) study is prospective cohort study aiming at evaluating COPD patients using simple basic tools normally used in the clinic at hand of any physician. The objective of the study is to accomplish specific aims. 1) describing the disease variation over time. 2) defining different disease behaviours; and 3) evaluating the impact of different therapeutic approaches on this behaviour in the different patient types. TRACE is a single center non-interventional prospective observational cohort study of COPD patients. Upon identification of cases, patients are followed-up in yearly visits sine die until death or lost to follow-up. Starting in 2012, during the yearly visits clinical, functional, radiological and analytical information is recorded via a standardized questionnaire. Variables recorded were: socio-demographics, tobacco history, comorbidities, clinical presentation during the previous year, exacerbations and hospitalization in the previous year, current pharmacological and non-pharmacological treatments, and complementary tests, including at least chest radiology, pre- and post-bronchodilator spirometry, and analytical results. Endpoints include a variety of clinically relevant variables including disease phenotypic expression, diagnostic measures and therapeutic responses.
Age
40 - 90 years
Sex
ALL
Healthy Volunteers
No
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain
Start Date
January 1, 2012
Primary Completion Date
December 1, 2021
Completion Date
December 1, 2021
Last Updated
February 12, 2020
1,440
ESTIMATED participants
Lead Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators
NCT07477600
NCT07462221
NCT07351929
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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