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

Recruiting

Conditions: chronic bronchitis
COPD
emphysema
10006436

Registration Number: NL-OMON31901

Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

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

• 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Number of exacerbations during two-year follow-up, including exacerbations<br /><br>requiring hospitalization and exacerbations managed by the primary care<br /><br>physicians<br /><br>• Number of deaths of any cause during the two-year follow-up<br /><br>• Number of respiratory-related deaths during the two-year follow-up<br /><br>• Time to next exacerbation, time to next exacerbation requiring<br /><br>hospitalization and time to death during the two-year follow-up</p><br>

Secondary Outcome Measures

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