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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Cimera
Sponsor:
Information provided by:
Cimera
ClinicalTrials.gov Identifier:
NCT01122758
First received: May 11, 2010
Last updated: November 27, 2012
Last verified: November 2012
  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:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

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

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
CIMERA  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: May 11, 2010
Last Updated: November 27, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Cimera:
Cohort
COPD
Natural history
Phenotyping
Smoking

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014