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Predictive Questionnaires for Risk of Acute COPD (Chronic Obstructive Pulmonary Disease) Exacerbations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01248507
First received: November 23, 2010
Last updated: October 27, 2016
Last verified: September 2016
  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

Further study details as provided by AstraZeneca:

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 ]
    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 ]
    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 ]

Enrollment: 634
Study Start Date: January 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

    1. Admitted to hospital due to AECOPD (severe exacerbation) or
    2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248507

Locations
Spain
Nycomed Pharma S.A.
Madrid, Spain, 28023
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01248507     History of Changes
Other Study ID Numbers: RO-2455-401-ES
NYC-EPOC-2009-01
U1111-1146-5711 ( Registry Identifier: UTN (Who) )
Study First Received: November 23, 2010
Last Updated: October 27, 2016

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 28, 2017