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

November 27, 2012 updated by: Cimera

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

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
- 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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cimera

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ANTICIPATED)

January 1, 2014

Study Completion (ANTICIPATED)

January 1, 2016

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 12, 2010

First Posted (ESTIMATE)

May 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHAIN
  • IB1323/10PI (OTHER: CEIC Illes Balears)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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