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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed Pharma S.A.

Madrid, 28023, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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 outcomes

To evaluate cardiovascular comorbidities as risk factors for the composite events in the hospital and the primary care cohorts.

Time frame: one year

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Nov 25, 2010
Registry last updated: Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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