Predictive Questionnaires for Risk of Acute COPD (Chronic Obstructive Pulmonary Disease) Exacerbations
This study is currently recruiting participants.
Verified May 2012 by Nycomed: A Takeda Company
Sponsor:
Nycomed: A Takeda Company
Information provided by (Responsible Party):
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT01248507
First received: November 23, 2010
Last updated: May 4, 2012
Last verified: May 2012
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Purpose
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.
| Condition |
|---|
|
COPD |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Nycomed: A Takeda Company:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
- Comparative evaluation of the predictive value of the CAT, CCQ, COPDSS and the AQ20 questionnaires (in primary care) [ Time Frame: one year ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- To evaluate cardiovascular comorbidities as risk factors for the composite events in the hospital and the primary care cohorts. [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
COPD patients
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248507
Contacts
| Contact: Takeda Study Registration Call Center | 1-800-778-2860 | medicalinformation@tpna.com |
Locations
| Spain | |
| Nycomed Pharma S.A. | Recruiting |
| Madrid, Spain, 28023 | |
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
| Study Chair: | Nycomed Clinical Trial Operations | Spain |
More Information
No publications provided
| Responsible Party: | Nycomed: A Takeda Company |
| ClinicalTrials.gov Identifier: | NCT01248507 History of Changes |
| Other Study ID Numbers: | RO-2455-401-ES, NYC-EPOC-2009-01 |
| Study First Received: | November 23, 2010 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Nycomed: A Takeda Company:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013