Time-based Register and Analysis of COPD Endpoints

NCT ID: NCT03485690

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2021-12-31

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.

Conditions

COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gebro Pharma GmbH

INDUSTRY

Sponsor Role: collaborator

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Luis Lopez-Campos, MD

Role: STUDY_CHAIR

Hospital Universitario Virgen del Rocio

Locations

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jose Luis Lopez-Campos, MD

Role: CONTACT

lopezcampos@separ.es

+34 955013167

Laura Carrasco, MD

Role: CONTACT

lauracarrascohdez@gmail.com

+34 955013166

Facility Contacts

Jose Luis Lopez-Campos, MD

Role: primary

josel.lopezcampos.sspa@juntadeandalucia.es

+34 955013167

Laura Carrasco, MD

Role: backup

lauracarrascohdez@gmail.com

+34 955013166

References

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.

Reference Type: DERIVED

PMID: 33921051 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33546927 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TRACE

Identifier Type: -

Identifier Source: org_study_id