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

NCT01248507 | Completed

• 3 other identifiers: RO-2455-401-ESNYC-EPOC-2009-01U1111-1146-5711
• Study Type: observational
• Target: 634
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  one year

• Comparative evaluation of the predictive value of the CAT, CCQ, COPDSS and the AQ20 questionnaires (in primary care)

  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.

  one year

Secondary Outcomes (1)

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

  one year

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Nycomed Pharma S.A.

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 25, 2010
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 31, 2016

Record last verified: 2016-09

Locations

ES (1)