Early diagnostic BioMARKers in Exacerbations of COPD: the MARKED study

Recruiting

Conditions: Chronic bronchitis
pulmonary emphysema
10024970

Registration Number: NL-OMON54493

Lead Sponsor: Ciro

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 162

Inclusion Criteria

COPD patients:
In order to be eligible to participate in this study, a patient must meet all
of the following criteria:
- >= 40 years old
- >= 10 packyears of smoking
- primary diagnosis of COPD and post-bronchodilator ratio of forced expiratory
volume in the first second (FEV1) to forced vital capacity (FVC) of less than
0.70.
- clinical indication for inpatient pulmonary rehabilitation in CIRO
- provided written informed consent

Exclusion Criteria

A potential COPD patient who meets any of the following criteria will be
excluded from participation in this study:
- current diagnosis of asthma
- unstable concurrent cardiovascular, metabolic, renal, gastro-intestinal and
musculoskeletal chronic diseases (as judged by the investigator)
- chronic use of oral corticosteroids >10 mg prednisolone/day
- initiation of maintenance therapy with macrolides < 6 weeks prior to study
entry
- anemia, defined as hemoglobin level < 8.1 mmol/L in men and < 7.5 mmol/L in
women
- participation in a study involving investigational or marketed products
concomitantly or < 8 weeks prior to study entry
- unable to read, speak or understand Dutch

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcome is the occurrence of COPD exacerbation during the<br /><br>study period. Symptoms, vital signs, spirometry, biomarkers in blood, sputum,<br /><br>nasal swabs and stools will be used to assess for explorative (bio)markers of<br /><br>exacerbations. We will focus on the period preceding the occurrence of clinical<br /><br>exacerbation. In this way, we will study markers for early diagnostics. Based<br /><br>on previous studies, it can be anticipated that exacerbations cannot be<br /><br>predicted by a single biomarker, and thus, we investigate a panel of<br /><br>explorative local and systemic (bio)markers). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical characteristics will be used as additional parameters: body<br /><br>composition, exacerbation history (in previous 12 months), dyspnea, health<br /><br>status, anxiety and depression, medical history, physical functioning etc. </p><br>