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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 December 2012 |
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Main ID: |
NCT01122758 |
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Date of registration:
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11/05/2010 |
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Primary sponsor: |
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Public title:
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Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN)
CHAIN |
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Scientific title:
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(COPD History Assessment In SpaiN): "Estudio Sobre la Evolución Multidimensional de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)". |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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2400 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01122758 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Spain
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Contacts
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Name:
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Ciro Casanova, MD |
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Address:
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Telephone:
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Email:
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casanovaciro@gmail.com |
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Affiliation:
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Name:
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Ciro Casanova, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Nuestra Señora de la Candelaria |
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Key inclusion & exclusion criteria
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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.
Age minimum:
35 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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COPD
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Primary Outcome(s)
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To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD
[Time Frame: 5 years]
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Secondary Outcome(s)
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- 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]
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Secondary ID(s)
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CHAIN
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IB1323/10PI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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