Time-based Register and Analysis of COPD Endpoints (TRACE)

February 11, 2020 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1440

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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)
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)
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)
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)
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
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
From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
Serum Alpha1-antitrypsin
Time Frame: At baseline
Serum Alpha1-antitrypsin
At baseline
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
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
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
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
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
From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Gebro Pharma GmbH

Investigators

  • Study Chair: Jose Luis Lopez-Campos, MD, Hospital Universitario Virgen Del Rocio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

April 2, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRACE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COPD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe