Time-based Register and Analysis of COPD Endpoints

NCT03485690 | Unknown DMC

• 1 other identifier: TRACE
• Study Type: observational
• Target: 1,440
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; Cohort study; Prospective

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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

• 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)

  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)

  From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits

Study Arms (1)

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

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Do not sign informed consent.
• With other relevant comorbidity that conditions their respiratory care

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Gebro Pharma GmbH: collaborator

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

RECRUITING

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Luis Lopez-Campos, MD

  Hospital Universitario Virgen del Rocio

  STUDY CHAIR

Central Study Contacts

Jose Luis Lopez-Campos, MD

CONTACT

+34 955013167; lopezcampos@separ.es

Laura Carrasco, MD

CONTACT

+34 955013166; lauracarrascohdez@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: April 2, 2018
• Study Start: January 1, 2012
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)