Time-based Register and Analysis of COPD Endpoints

NCT03485690 — Completed, 1440 participants, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT03485690, acronym TRACE
Status	Completed
Study type	Observational
Enrollment	1440 (Actual)
Sponsor	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other); collaborators: Gebro Pharma GmbH
Conditions	COPD
Dates	start 2012-01-01, primary completion 2026-04-15, completion 2026-04-15, first posted 2018-04-02, last updated 2026-09-03
Locations	1 site in Spain

-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.

Expand all sections · Collapse all

+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

+Arms and interventions

Arm	Type	Interventions	Description
COPD			COPD patients with no restrictions, generally above 40 years of age, both genders. The study protocol does not consider ad-hoc different patient groups. Prospective follow-up will be equally done in all recruited patients. This is a real-life study. Therefore, group description is not restrictive.

+Outcome measures

Primary outcomes

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 outcomes

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
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
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

+Eligibility

Sex: All, ages: 40 Years to 90 Years

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

+Locations (1)

Facility	City	Country	Status
Hospital Universitario Virgen del Rocio	Seville, Andalusia	Spain

+Publications

Results publication: 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. PMID 33921051
Results publication: 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. PMID 33546927

+Study documents

Study Protocol (PDF, 2018-02-02)
Statistical Analysis Plan (PDF, 2018-02-02)

+Investigators

Jose Luis Lopez-Campos, MD, Study chair, Hospitales Universitarios Virgen del Rocío

My Notes

Public

To Read Reading Read