(COPD History Assessment In SpaiN): "Estudio Sobre la Evolución Multidimensional de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)".
35 Years
80 Years
Both
COPD
Trial Information
(COPD History Assessment In SpaiN): "Estudio Sobre la Evolución Multidimensional de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)".
Observational studies are needed to ascertain the natural history and progression of COPD,
and to better define its phenotypes. These two aspects are considered fundamental to a
proper evaluation of current (and future) COPD treatment options, and it could possibly
justify the limited impact of recent major drug trials.
Currently, there remain gaps in the natural history of patients with COPD. Most data are
from analysis of mild COPD patients or smokers, usually measuring only fall in FEV1, and
both have significant limitations in design and interpretation.
Studies in more severe patients with COPD have also been conducted mainly by studying lung
function, possibly influenced by the recommendations of current guidelines for disease
management. In recent years, we have more longitudinal data on changes in exercise capacity,
imaging, and biomarkers, among other variables of interest, but our knowledge is yet
partial.
The research project CHAIN (COPD Assessment History in Spain): "A Multidimensional Study on
the Evolution of Chronic Obstructive Pulmonary Disease (COPD) is a multicenter observational
study that will follow prospectively two cohorts: a) a COPD group active or former smokers
(COPD cohort) and b) a group of active smokers or former smokers without COPD (control
cohort). Both cohorts will be followed up for a period of at least 5 years, with visits
every 12 months (and phone controls at least every 6 months). We will try to extend the
monitoring of the cohort up to 10 years. CHAIN is supported by the PII of COPD SEPAR
Inclusion Criteria:
- Patients ≥ 35 years.
- Diagnosis of COPD (GOLD PBD FEV1/FVC ratio <0.70).
- Being in a stable phase of disease (8 weeks without exacerbation).
- Cummulative smoking ≥ 10 pack-years.
- Absence of asthma or other chronic respiratory disease that justify the ventilatory
disorder (although a history of asthma is not an exclusion criteria);
- Absence of malignancy or very serious comorbidities that would prevent study
completion.
Exclusion Criteria:
- Patients <35 years.
- Recent exacerbation (<8 weeks).
- Not giving written informed consent.
- Presence of asthma or other chronic respiratory disease justifying the ventilatory
disorder,
- Diffuse bronchiectasis not associated with COPD.
- Presence of malignancy or very serious comorbidities that would prevent study
completion.
- Difficulty to perform appropriate follow-up.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Ciro Casanova, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Nuestra Señora de la Candelaria
Authority:
Spain: Comité Ético de Investigación Clínica
Study ID:
CHAIN
NCT ID:
NCT01122758
Start Date:
December 2009
Completion Date:
January 2016
Related Keywords:
- COPD
- Cohort
- COPD
- Natural history
- Phenotyping
- Smoking
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Lung Diseases, Obstructive
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