Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN) (CHAIN)
Recruitment status was: Recruiting
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||(COPD History Assessment In SpaiN): "Estudio Sobre la Evolución Multidimensional de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)".|
- To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- - Progression of the disease by degree of severity. - Effect of treatment on disease progression and variability of response according to phenotypes. - Geographical differences. - The impact of exacerbations. - The importance of comorbidities and [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122758
|Santa Cruz de Tenerife, Canarias, Spain|
|40-50 additional centres throughout Spain|
|Bunyola, Spain, 07110|
|Principal Investigator:||Ciro Casanova, MD||Hospital Nuestra Señora de la Candelaria|