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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2012 by Cimera.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01122758

First Posted: May 13, 2010

Last Update Posted: November 28, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Cimera

Purpose

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

Condition
COPD


Study Type:	Observational
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)".

Resource links provided by NLM:

MedlinePlus related topics: Health Checkup

U.S. FDA Resources

Further study details as provided by Cimera:

Primary Outcome Measures:

To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD [ Time Frame: 5 years ]

Secondary Outcome Measures:

- 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 ]

Biospecimen Retention: Samples Without DNA

complete blood and serum samples


Estimated Enrollment:	2400
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)

Groups/Cohorts
COPD cohort 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.
Control cohort Inclusion criteria: Patients ≥ 35 years. Absence of diagnosis of COPD (GOLD PBD FEV1/FVC ratio >=0.70). 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. 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.

Groups/Cohorts

COPD cohort

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.

Control cohort

Inclusion criteria:

Patients ≥ 35 years.
Absence of diagnosis of COPD (GOLD PBD FEV1/FVC ratio >=0.70).
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.
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.

Detailed 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

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	35 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Participants will be selected from the outpatient clinics, pulmonary function labs, and / or pulmonology wards of each participating center

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122758

Contacts


Contact: Ciro Casanova, MD		casanovaciro@gmail.com
Contact: Joan B Soriano, MD	34971148437	jbsoriano@caubet-cimera.es

Locations


Spain
Ciro Casanova	Recruiting
Santa Cruz de Tenerife, Canarias, Spain
Contact: Ciro Casanova casanovaciro@gmail.com
40-50 additional centres throughout Spain	Recruiting
Bunyola, Spain, 07110
Contact: Joan B Soriano, 724 34971148437 jbsoriano@caubet-cimera.es
Contact: 724 724 724, 724 34971148437 jbsoriano@caubet-cimera.es

Sponsors and Collaborators

Cimera

Investigators


Principal Investigator:	Ciro Casanova, MD	Hospital Nuestra Señora de la Candelaria

More Information

Additional Information:

SEPAR-Sociedad Española de Neumología y Cirugía Torácica This link exits the ClinicalTrials.gov site

CIMERA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cosio BG, Soriano JB, López-Campos JL, Calle-Rubio M, Soler-Cataluna JJ, de-Torres JP, Marín JM, Martínez-Gonzalez C, de Lucas P, Mir I, Peces-Barba G, Feu-Collado N, Solanes I, Alfageme I, Casanova C; CHAIN Study. Defining the Asthma-COPD Overlap Syndrome in a COPD Cohort. Chest. 2016 Jan;149(1):45-52. doi: 10.1378/chest.15-1055. Epub 2016 Jan 6.

Casanova C, Marin JM, Martinez-Gonzalez C, de Lucas-Ramos P, Mir-Viladrich I, Cosio B, Peces-Barba G, Solanes-García I, Agüero R, Feu-Collado N, Calle-Rubio M, Alfageme I, de Diego-Damia A, Irigaray R, Marín M, Balcells E, Llunell A, Galdiz JB, Golpe R, Lacarcel C, Cabrera C, Marin A, Soriano JB, Lopez-Campos JL, Soler-Cataluña JJ, de-Torres JP; COPD History Assessment in Spain (CHAIN) Cohort. Differential Effect of Modified Medical Research Council Dyspnea, COPD Assessment Test, and Clinical COPD Questionnaire for Symptoms Evaluation Within the New GOLD Staging and Mortality in COPD. Chest. 2015 Jul;148(1):159-168. doi: 10.1378/chest.14-2449.

de Torres JP, Marin JM, Martinez-Gonzalez C, de Lucas-Ramos P, Mir-Viladrich I, Cosio B, Peces-Barba G, Calle-Rubio M, Solanes-García I, Agüero Balbin R, de Diego-Damia A, Feu-Collado N, Alfageme Michavila I, Irigaray R, Balcells E, Llunell Casanovas A, Galdiz Iturri JB, Marín Royo M, Soler-Cataluña JJ, Lopez-Campos JL, Soriano JB, Casanova C; COPD History Assessment in Spain (CHAIN) Cohort*. Clinical application of the COPD assessment test: longitudinal data from the COPD History Assessment in Spain (CHAIN) cohort. Chest. 2014 Jul;146(1):111-122. doi: 10.1378/chest.13-2246.


Responsible Party:	Dr Ciro Casanova, Hospital Universitario Nuestra Señora de la Candelaria
ClinicalTrials.gov Identifier:	NCT01122758 History of Changes
Other Study ID Numbers:	CHAIN IB1323/10PI ( Other Identifier: CEIC Illes Balears )
First Submitted:	May 11, 2010
First Posted:	May 13, 2010
Last Update Posted:	November 28, 2012
Last Verified:	November 2012

Keywords provided by Cimera:


Cohort COPD Natural history Phenotyping Smoking

Additional relevant MeSH terms:


Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases

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