Exploring biomarkers for COPD exacerbations
Early Diagnostic BioMARKers in Exacerbations of COPD: the MARKED Study
This study is trying to find markers in blood, sputum, and stool that can predict flare-ups in people with COPD to help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Center of Expertise for Chronic Organ Failure Academic / other |
| Locations | 1 site (Horn, Limburg) |
| Trial ID | NCT05315674 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify biomarkers that can predict acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) by analyzing various samples including sputum, blood, and stool. It will follow patients over eight weeks to investigate changes in microbial composition and host-microbiome interactions during stable periods, exacerbations, and recovery. The study also seeks to characterize the heterogeneity of exacerbations through comprehensive clinical and biological assessments. By understanding these factors, the research hopes to improve management strategies for COPD patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with a primary diagnosis of COPD and a history of smoking.
Not a fit: Patients with recent asthma diagnoses or unstable chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and management of COPD exacerbations, ultimately improving patient outcomes.
How similar studies have performed: While the approach of exploring biomarkers in COPD is not entirely novel, the specific focus on microbiome interactions and longitudinal analysis may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥40 years old * ≥10 pack years 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: * current, i.e. \<12 months, (secondary) diagnosis of asthma according to the referring physician * 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
Where this trial is running
Horn, Limburg
- Ciro — Horn, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Frits ME Franssen, Prof. Dr. — Center of Expertise for Chronic Organ Failure
- Study coordinator: Kiki Waeijen-Smit, MSc
- Email: kikismit@ciro-horn.nl
- Phone: +31475587601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.