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Completed

NCT Number: NCT03485690

Time-based Register and Analysis of COPD Endpoints

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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Key information

Conditions

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

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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

  7. Serum Alpha1-antitrypsin

    Time frame: At baseline

    Serum Alpha1-antitrypsin

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Gebro Pharma GmbH

Registry information

Acronym: TRACE

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2018
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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