- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01248507
Predictive Questionnaires for Risk of Acute COPD (Chronic Obstructive Pulmonary Disease) Exacerbations
Comparative Evaluation of COPD Specific Quality of Life Assessment Questionnaires (the COPD Assessment Test, the Clinical COPD Questionnaire, the COPD Severity Score and the Airways Questionnaire 20 as Predictive Tools for Risk of Acute COPD Exacerbations
COPD patients frequently suffer intermittent exacerbations of their disease characterised by acute deterioration of symptoms. Acute exacerbations of COPD (AECOPD) are associated with significant impairment of health status, use of health care resources, poor prognosis and increased mortality. The development of simple and practical predictive tools would help to identify COPD patients at greater risk of suffering exacerbations, which is important since those patients would need more intense and early treatment.
This one-year prospective cohort non-drug study will evaluate several COPD-specific questionnaires as predictive tools and the presence of cardiovascular comorbidities as risk factors, for the composite events in study cohorts. The trial duration consists of a screening period (4-6 weeks) and a follow-up period (12 months), 4 visits in total along the study.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain, 28023
- Nycomed Pharma S.A.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Signed informed consent
- Age ≥ 40 years
- Patients fulfilling criteria for COPD according to the Global initiative for chronic obstructive pulmonary disease (GOLD) stage I or higher
- Smokers or ex-smokers of at least 10 pack-years
Patients suffering an AECOPD either:
- Admitted to hospital due to AECOPD (severe exacerbation) or
- Confirmed AECOPD at GP (general practitioner) setting (moderate exacerbation) Definition AECOPD: Increase in respiratory symptoms requiring treatment with oral corticosteroids, antibiotics or both.
Exclusion Criteria:
- Patients who have never smoked
- Patients with active long-term respiratory disease (e.g. bronchial asthma, cystic fibrosis, severe bronchiectasis, malignancy, restrictive lung diseases etc.)
- Exacerbation of COPD due to other causes such as pneumothorax and acute decompensated congestive heart failure
- Difficulties in communication (cognitive deterioration, sensorial disability, language barriers)
- Severe disease with poor vital prognosis (life length expectancy less than one year)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparative evaluation of the predictive value of the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), COPD Severity Score (COPDSS) and the Airways Questionnaire 20 (AQ20) questionnaires (in hospital)
Time Frame: one year
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Comparative evaluation of the predictive value of the CAT, CCQ, COPDSS and the AQ20 questionnaires for the composite event of mortality and re-hospitalization for COPD, in a one year follow-up of a cohort of COPD patients admitted for an exacerbation, enrolled in hospital.
|
one year
|
Comparative evaluation of the predictive value of the CAT, CCQ, COPDSS and the AQ20 questionnaires (in primary care)
Time Frame: one year
|
Comparative evaluation of the predictive value of the CAT, CCQ, COPDSS and the AQ20 questionnaires for the composite event of any exacerbation, mortality and hospitalization for COPD, in a one-year follow-up of a cohort of COPD patients enrolled in primary care.
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate cardiovascular comorbidities as risk factors for the composite events in the hospital and the primary care cohorts.
Time Frame: one year
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one year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RO-2455-401-ES
- NYC-EPOC-2009-01
- U1111-1146-5711 (Registry Identifier: UTN (Who))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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