Early diagnostic BioMARKers in Exacerbations of COPD: the MARKED study

Early diagnostic BioMARKers in Exacerbations of COPD: the MARKED study - the MARKED study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54493

Enrollment

162

Registered

2019-09-10

Start date

2022-07-25

Completion date

Unknown

Last updated

2026-04-14

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

Conditions

Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Clinical characteristics will be used as additional parameters: body composition, exacerbation history (in previous 12 months), dyspnea, health status, anxiety and depression, medical history, physical functioning etc.	—

Countries

Netherlands

Contacts

Public ContactD.E.M. Peerlings

CIRO

daphnepeerlings@ciro-horn.nl+31 (0)475 587 602

Outcome results