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

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ClinicalTrials.gov Identifier: NCT01122758
Recruitment Status : Unknown
Verified November 2012 by Cimera.
Recruitment status was:  Recruiting
First Posted : May 13, 2010
Last Update Posted : November 28, 2012
Sponsor:
Information provided by:
Cimera

Study Description
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Brief 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

Condition or disease
COPD

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


Study Design
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Study Type : Observational
Estimated Enrollment : 2400 participants
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)".
Study Start Date : December 2009
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Groups and Cohorts
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Group/Cohort
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.


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

Secondary Outcome Measures :
  1. - 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

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
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
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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
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Additional Information:
SEPAR-Sociedad Espa&#241;ola de Neumolog&#237;a y Cirug&#237;a Tor&#225;cica  This link exits the ClinicalTrials.gov site
CIMERA  This link exits the ClinicalTrials.gov site

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

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 Posted: May 13, 2010    Key Record Dates
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