Time-based Register and Analysis of COPD Endpoints

COPD Clinical Trial

— TRACE  

Official title:

Time-based Register and Analysis of COPD Endpoints

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03485690
• Other study ID #: TRACE
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Jose Luis Lopez-Campos, MD
• Phone: +34 955013167
• Email: lopezcampos[@]separ.es
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocio	Sevilla	Andalucia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Gebro Pharma GmbH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	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	dyspnea	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
Secondary	Number of moderate or severe exacerbations	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
Secondary	FEV1 annual decline	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
Secondary	Forced expiratory flow at 25-75% of expiration (FEF25-75)	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
Secondary	Peak expiratory flow (PEF)	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
Secondary	Peripheral blood eosinophils count	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
Secondary	Serum Alpha1-antitrypsin	Serum Alpha1-antitrypsin	At baseline
Secondary	Total IgE	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
Secondary	Positive bronchial colonization	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
Secondary	Inhaled and oral COPD-related medication use	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