Clinical trial NCT03485690: Time-based Register and Analysis of COPD Endpoints
Official title: Time-based Register and Analysis of COPD Endpoints
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Keywords: COPD
Cohort study
Prospective
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Gebro Pharma GmbH
First posted: 2018-04-02
Enrollment: 1440
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: 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:
measure: dyspnea
timeFrame: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
measure: Number of moderate or severe exacerbations
timeFrame: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
measure: FEV1 annual decline
timeFrame: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
measure: Forced expiratory flow at 25-75% of expiration (FEF25-75)
timeFrame: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
measure: Peak expiratory flow (PEF)
timeFrame: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
measure: Peripheral blood eosinophils count
timeFrame: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
measure: Serum Alpha1-antitrypsin
timeFrame: At baseline
measure: Total IgE
timeFrame: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
measure: Positive bronchial colonization
timeFrame: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
measure: Inhaled and oral COPD-related medication use
timeFrame: From date of randomization until the date of death from any cause or lost to follow-up, whichever came first, assessed in yearly visits
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucia
Study officials:
affiliation: Hospital Universitario Virgen del Rocio
name: Jose Luis Lopez-Campos, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.