An Exploratory Observational, Single-Centre Study in Patients with Disabling Chronic Obstructive Pulmonary Disease to Identify Biomarkers for *Systemic Disease*, Co-Morbidities, Increased Health Care Costs and Poor Prognosis. (CIROCO).

Recruiting

• Conditions: chronic bronchitis; emphysema; 10006436

• Registration Number: NL-OMON39306
• Lead Sponsor: Astra Zeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 310

Inclusion Criteria

Severe COPD: 1: referred to the CIRO in Horn for a lung rehabiliation program 2: agreeing to participate and signed informed consent, 3: age 40 - 80 year, 4: lungfunction (post-bronchodilator FEV1) below 80% of predicted, 5: ratio FEV1 / FVC (post-bronchodilator) below 0.70, 6: current or ex-smoker with at least 10 pack-years
Healthy control subjects: 1: agreeing yto participate and signed informed consent , 2; age 40 - 80 years, 3: healthy, 4: lungfunction (post-bronchodilator FEV1) above 85% of predicted, 5: Ratio FEV1 / FVC (post bronchodilator) above 85% of predicted, 6: non-smoker or ex-smoker with less than 10 pack-years.
Mild COPD: 1: agreeing to particpate and signed informed consent , 2: COPD diagnosis confirmed in the BOLD project.

Exclusion Criteria

All participants: history of asthma, other lung disease, severe cardiac disease, rheumatoid arthritis, bone disease, other concomitant disease, malignancy, pregnancy, physical handicap making walking impossible, alcohol or drug abuse, recent blood donation.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Biomarkers in the blood, a range of approximately 20 parameters, there will be<br /><br>a search for predicting factors on exacerbation frequency and mortality on the<br /><br>long term and for the effect of the lung rehabilitation on these biomarkers on<br /><br>the short term. The number of exacerbations will be recorded.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Investigating the number of exacerbations, hospitalisations, progression of<br /><br>COPD, mortality, health care use, quality of life over a long term follow-up<br /><br>period.<br /><br>Searching for correlations between biomarkers in blood and bonde density,<br /><br>muscle quality and peripheral vasculature quality. Studying the effects of<br /><br>rehabilitation program on muscle quality.</p><br>