COPD
Conditions
Keywords
COPD, Cohort study, Prospective
Brief summary
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.
Detailed description
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. To include new cases, a retrospective review of patients who meet the inclusion / exclusion criteria will be done. For this, proceed as follows: the COPD-dedicated outpatient clinic of the principal investigator will be reviewed to evaluate all the patients that were evaluated in this consultation. Once identified, those who are still in follow-up will be selected and the data will be collected for inclusion. Subsequently, the patients included will be followed up prospectively with annual visits until their death or loss of follow-up, as per clinical practice in our institution
Interventions
None listed
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Gebro Pharma GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dyspnea | From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits | dyspnea measured by mMRC scale |
| Number of moderate or severe exacerbations | 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, as defined by GOLD 2017 |
| 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 | FEV1 annual decline |
| 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 | Forced expiratory flow at 25-75% of expiration (FEF25-75) |
| 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 | Peak expiratory flow (PEF) |
| 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 | Peripheral blood eosinophils count |
| Serum Alpha1-antitrypsin | At baseline | Serum Alpha1-antitrypsin |
| 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 | Total IgE |
| 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 | Inhaled and oral COPD-related medication use |
| 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 | Positive bronchial colonization |
Countries
Spain
Contacts
STUDY_CHAIRJose Luis Lopez-Campos, MD
Hospitales Universitarios Virgen del Rocío
Outcome results
None listed