Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN)

COPD Clinical Trial

— CHAIN  

Official title:

(COPD History Assessment In SpaiN): "Estudio Sobre la Evolución Multidimensional de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)".

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01122758
• Other study ID #: CHAIN
• Secondary ID: IB1323/10PI
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2010
• Last updated: November 27, 2012
• Start date: December 2009
• Est. completion date: January 2016

Study information

• Verified date: November 2012
• Source: Cimera
• Contact: Ciro Casanova, MD
• Email: casanovaciro[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial Summary

The research project CHAIN (COPD Assessment History in Spain): "A Multidimensional Study on the Evolution of Chronic Obstructive Pulmonary Disease (COPD)is a multicentre, observational study conducted in several areas of Spain aimed to better define COPD natural history and its phenotypes

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: January 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	40-50 additional centres throughout Spain	Bunyola
Spain	Ciro Casanova	Santa Cruz de Tenerife	Canarias

Sponsors (1)

Lead Sponsor	Collaborator
Cimera

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD		5 years	No
Secondary	- 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		5 years	No

External Links

•   CIMERA
•   SEPAR-Sociedad Española de Neumología y Cirugía Torácica