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

Completed

• Conditions: COPD

• Registration Number: NCT01248507
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Study Start: 2011-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	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)	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

Name	Time	Method
To evaluate cardiovascular comorbidities as risk factors for the composite events in the hospital and the primary care cohorts.	one year

Trial Locations

Locations (1)

Nycomed Pharma S.A.; 🇪🇸 Madrid, Spain