Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN) (CHAIN)
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| ClinicalTrials.gov Identifier: NCT01122758 |
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Recruitment Status : Unknown
Verified November 2012 by Cimera.
Recruitment status was: Recruiting
First Posted : May 13, 2010
Last Update Posted : November 28, 2012
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| Condition or disease |
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| COPD |
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 |
| 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 |
| Group/Cohort |
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COPD cohort
Inclusion criteria:
Exclusion criteria:
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Control cohort
Inclusion criteria:
Exclusion criteria:
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- To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD [ Time Frame: 5 years ]
- - 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
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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 |
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.
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
| Contact: Ciro Casanova, MD | casanovaciro@gmail.com | ||
| Contact: Joan B Soriano, MD | 34971148437 | jbsoriano@caubet-cimera.es |
| 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 | |
| Principal Investigator: | Ciro Casanova, MD | Hospital Nuestra Señora de la Candelaria |
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 |
| 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 |
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Cohort COPD Natural history Phenotyping Smoking |