COPDTRACENCT03485690
Time-based Register and Analysis of COPD Endpoints
An observational study of COPD, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD
- How many people
- 1,440 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2012to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Do not sign informed consent.
- With other relevant comorbidity that conditions their respiratory care
Trial locations and contacts
1 site in 1 country.
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. 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.
Read the detailed description
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
- Conditions
- COPD
- Keywords
- COPD, Cohort study, Prospective
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD | COPD patients with no restrictions, generally above 40 years of age, both genders. The study protocol does not consider ad-hoc different patient groups. Prospective follow-up will be equally done in all recruited patients. This is a real-life study. Therefore, group description is not restrictive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival
Measured: 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
dyspnea measured by mMRC scale
Measured: 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
Number of moderate or severe exacerbations, as defined by GOLD 2017
Measured: 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
FEV1 annual decline
Measured: 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)
Forced expiratory flow at 25-75% of expiration (FEF25-75)
Measured: 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)
Peak expiratory flow (PEF)
Measured: 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
Peripheral blood eosinophils count
Measured: 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
Serum Alpha1-antitrypsin
Measured: At baseline
Total IgE
Total IgE
Measured: 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
Positive bronchial colonization
Measured: 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
Inhaled and oral COPD-related medication use
Measured: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Jan 2012
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Gebro Pharma GmbH
- Responsible party
- Sponsor
- Investigators
- Jose Luis Lopez-Campos, MD, Study chair, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485690
- Sponsor's protocol ID
- TRACE
- Acronym
- TRACE
- Status last verified
- Sep 2026
- First submitted
- 12 Feb 2018
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33921051Carrasco 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.
PubMed 33546927
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-based Register and Analysis of COPD Endpoints
- ClinicalTrials.gov ID
- NCT03485690
- Acronym / sponsor ID
- TRACE / TRACE
- Conditions
- COPD
- Keywords
- COPD, Cohort study, Prospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Gebro Pharma GmbH
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –COPD patients with no restrictions, generally above 40 years of age, both genders. The study protocol does not consider ad-hoc different patient groups. Prospective follow-up will be equally done in all recruited patients. This is a real-life study. Therefore, group description is not restrictive. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Do not sign informed consent.
- With other relevant comorbidity that conditions their respiratory care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
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
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
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
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
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
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
Serum Alpha1-antitrypsin
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 33921051Carrasco 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.
- Derived from this study: PubMed 33546927Carrasco 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Lopez-Campos, MD study chair
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485690, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.