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

AstraZeneca

Status: Completed

Conditions: COPD

Study type: Observational

Funder types: Industry

Identifiers

NCT01248507

RO-2455-401-ES

NYC-EPOC-2009-01

U1111-1146-5711 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 634 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)