Time-based Register and Analysis of COPD Endpoints

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2019

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Survival
    • Time Frame: 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 Measures

  • dyspnea
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: At baseline
    • Serum Alpha1-antitrypsin
  • Total IgE
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
  • Collaborator
    • Gebro Pharma GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jose Luis Lopez-Campos, MD, Study Chair, Hospital Universitario Virgen del Rocio
  • Overall Contact(s)
    • Jose Luis Lopez-Campos, MD, +34 955013167, lopezcampos@separ.es

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