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PRedicting Outcome using systemic Markers In Severe Exacerbations of COPD - The PROMISE-COPD Cohort Study

PRedicting Outcome using systemic Markers In Severe Exacerbations of COPD - The PROMISE-COPD Cohort Study - Systemic makers in severe exacerbations of COPD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31901
Enrollment
150
Registered
2008-06-30
Start date
2008-09-24
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic bronchitis COPD emphysema

Interventions

None listed

Sponsors

Medisch Centrum Alkmaar
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age above 40 years; • Smoking history >= 10 pack years; • Moderate to very severe COPD (GOLD II to IV); • Currently stable disease (at least 4 weeks after resolution of the last exacerbation); • Willingness to participate in a longitudinal, cohort study; • Willingness of the family physician to have the patient included in a cohort study; • Written informed consent.

Exclusion criteria

Exclusion criteria: • Rapid fatal disease; • Pulmonary condition other than COPD as the main respiratory disease, e.g. bronchiectasis, asthma or pulmonary fibrosis; • Immunosuppression including HIV, organ transplantation or chronic steroid use (more than 10mg prednisolone-equivalent per day); • Patients unable and unwilling to give written informed consent; • Muskulo-skeletal process preventing ambulation.

Design outcomes

Primary

MeasureTime frame
• Number of exacerbations during two-year follow-up, including exacerbations requiring hospitalization and exacerbations managed by the primary care physicians • Number of deaths of any cause during the two-year follow-up • Number of respiratory-related deaths during the two-year follow-up • Time to next exacerbation, time to next exacerbation requiring hospitalization and time to death during the two-year follow-up

Secondary

MeasureTime frame
• Length of stay during hospitalization • Admission and length of stay in intensive care unit • Need for intubation or non-invasive ventilation • Need for oral steroids and antibiotics • Quality of life assessed by Saint Georges Respiratory Questionnaire and SF-36 • Dyspnoea and respiratory symptoms as assessed by the MMRC and LRTI-VAS • Lung function and 6-minute walk test changes

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)