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| Name | Class |
|---|---|
| Gebro Pharma GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD | 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 |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The studied population will be composed solely of COPD patients. Adult patients with a diagnosis of COPD according to current standards (7), i.e. a tobacco history > 10 pack-years and a post-bronchodilator spirometry with an expiratory volume in the first second (FEV1) / forced vital capacity (FVC) ratio < 0.7, routinely followed-up in our outpatient clinic were selected for inclusion.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Luis Lopez-Campos, MD | Contact | +34 955013167 | lopezcampos@separ.es | |
| Laura Carrasco, MD | Contact | +34 955013166 | lauracarrascohdez@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jose Luis Lopez-Campos, MD | Hospitales Universitarios Virgen del RocÃo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | Andalusia | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33921051 | Derived | Carrasco Hernandez L, Caballero Eraso C, Ruiz-Duque B, Abad Arranz M, Marquez Martin E, Calero Acuna C, Lopez-Campos JL. Predictors of Single Bronchodilation Treatment Response for COPD: An Observational Study with the Trace Database Cohort. J Clin Med. 2021 Apr 15;10(8):1708. doi: 10.3390/jcm10081708. | |
| 33546927 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2018 | Apr 3, 2018 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2018 | Apr 3, 2018 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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 |
| Carrasco Hernandez L, Caballero Eraso C, Ruiz-Duque B, Abad Arranz M, Marquez Martin E, Calero Acuna C, Lopez-Campos JL. Deconstructing Phenotypes in COPD: an Analysis of the TRACE Cohort. Arch Bronconeumol. 2022 Jan;58(1):30-34. doi: 10.1016/j.arbres.2020.12.010. Epub 2021 Jan 4. English, Spanish. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |