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

May 11, 2010
November 27, 2012
December 2009
January 2014   (final data collection date for primary outcome measure)
To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01122758 on ClinicalTrials.gov Archive Site
- 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 ]
Same as current
Not Provided
Not Provided
 
Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN)
(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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

complete blood and serum samples

Non-Probability Sample

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

COPD
Not Provided
  • 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.
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):111-22. doi: 10.1378/chest.13-2246.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2400
January 2016
January 2014   (final data collection date for primary outcome measure)

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.
Both
35 Years to 80 Years
Yes
Contact: Ciro Casanova, MD casanovaciro@gmail.com
Contact: Joan B Soriano, MD 34971148437 jbsoriano@caubet-cimera.es
Spain
 
NCT01122758
CHAIN, IB1323/10PI
No
Dr Ciro Casanova, Hospital Universitario Nuestra Señora de la Candelaria
Cimera
Not Provided
Principal Investigator: Ciro Casanova, MD Hospital Nuestra Señora de la Candelaria
Cimera
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP