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

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.
 
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

Tracking Information
First Submitted Date May 11, 2010
First Posted Date May 13, 2010
Last Update Posted Date November 28, 2012
Study Start Date December 2009
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2010)
To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01122758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 12, 2010)
- 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN)
Official Title (COPD History Assessment In SpaiN): "Estudio Sobre la Evolución Multidimensional de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)".
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
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
complete blood and serum samples
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
Condition COPD
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 12, 2010)
2400
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2016
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01122758
Other Study ID Numbers CHAIN
IB1323/10PI ( Other Identifier: CEIC Illes Balears )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Ciro Casanova, Hospital Universitario Nuestra Señora de la Candelaria
Study Sponsor Cimera
Collaborators Not Provided
Investigators
Principal Investigator: Ciro Casanova, MD Hospital Nuestra Señora de la Candelaria
PRS Account Cimera
Verification Date November 2012