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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).

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). - CIROCO study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39306
Enrollment
310
Registered
2007-07-04
Start date
2007-11-19
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

chronic bronchitis emphysema

Interventions

None listed

Sponsors

Astra Zeneca
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Biomarkers in the blood, a range of approximately 20 parameters, there will be a search for predicting factors on exacerbation frequency and mortality on the long term and for the effect of the lung rehabilitation on these biomarkers on the short term. The number of exacerbations will be recorded.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)