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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01248507
First received: November 23, 2010
Last updated: August 16, 2013
Last verified: August 2013
  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 Takeda:

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 ]

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
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:

    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
Takeda
Investigators
Study Chair: Nycomed Clinical Trial Operations Spain
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01248507     History of Changes
Other Study ID Numbers: RO-2455-401-ES, NYC-EPOC-2009-01, U1111-1146-5711
Study First Received: November 23, 2010
Last Updated: August 16, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Takeda:
COPD

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

ClinicalTrials.gov processed this record on September 22, 2014