Time-based Register and Analysis of COPD Endpoints

Study Overview
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Brief Summary
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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.

Official Title
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Time-based Register and Analysis of COPD Endpoints

Conditions
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COPD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Diagnosed of COPD, according to the current recommendations Evaluated in our COPD outpatient clinic in 2012 or the following years With three years of follow-up at least Exclusion Criteria: Do not sign informed consent. With other relevant comorbidity that conditions their respiratory care

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD<br>COPD patients with no restrictions. The study protocol does not consider ad-hoc different patient groups. Prospective follow-up will be equally done in all recruited patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits, up to ten years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dyspnea | dyspnea measured by mMRC scale | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | 
| Number of moderate or severe exacerbations | Number of moderate or severe exacerbations, as defined by GOLD 2017 | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | 
| FEV1 annual decline | FEV1 annual decline | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | 
| Forced expiratory flow at 25-75% of expiration (FEF25-75) | Forced expiratory flow at 25-75% of expiration (FEF25-75) | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | 
| Peak expiratory flow (PEF) | Peak expiratory flow (PEF) | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | 
| Peripheral blood eosinophils count | Peripheral blood eosinophils count | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | 
| Serum Alpha1-antitrypsin | Serum Alpha1-antitrypsin | At baseline | 
| Total IgE | Total IgE | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | 
| Positive bronchial colonization | Positive bronchial colonization | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | 
| Inhaled and oral COPD-related medication use | Inhaled and oral COPD-related medication use | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Cohort study, Prospective