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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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17 October 2012 |
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Main ID: |
NCT01266395 |
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Date of registration:
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21/12/2010 |
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Primary sponsor: |
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Public title:
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Impact of Morning Symptoms in Clinical Control of Chronic Obstructive Pulmonary Disease (COPD)
IMPAEPOC |
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Scientific title:
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Impact of Morning Symptoms in Clinical Control of COPD |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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1268 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01266395 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Cross-Sectional
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Countries of recruitment
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Spain
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient has signed informed consent form
- Patients of both sexes,> 40 years.
- Patients diagnosed with COPD according to global consensus on the definition,
classification and management of the disease (GOLD) criteria:
- post-bronchodilator forced expiratory volume in 1 s (FEV1) / forced vital
capacity (FVC) <70%
- post-bronchodilator FEV1 <80% (stage II, III and IV)
Exclusion Criteria:
- Participating in an epidemiological study or clinical trial
- Patient with other respiratory disease than COPD (eg bronchial asthma, cystic
fibrosis, severe bronchiectasis, restrictive lung disease, cancer, etc.).
- Patients with mild COPD: FEV1> 80%
Age minimum:
40 Years
Age maximum:
N/A
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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Determine if there are differences in the impact of COPD on patients according to the characteristics of the disease. To measure the impact of specific self-administered questionnaires used in COPD: CDLMQ, GCSQ and CCQ
[Time Frame: Retrospective, (previous 24 months)]
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Secondary Outcome(s)
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Assess comorbidities as a risk factor for frequent exacerbations
[Time Frame: Retrospective, (previous 24 months)]
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Secondary ID(s)
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NIS-RES-DUM-2010/2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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