Status:
UNKNOWN
Markers of COPD Exacerbations
Lead Sponsor:
Center of Expertise for Chronic Organ Failure
Collaborating Sponsors:
AstraZeneca
Conditions:
COPD
COPD Exacerbation
Eligibility:
All Genders
40+ years
Brief Summary
Acute exacerbations of COPD (AECOPD) are episodes of acute worsening of respiratory symptoms that require additional therapy. Exacerbations play a pivotal role in the burden and progressive course of ...
Detailed Description
The MARKED study is an exploratory, prospective, single-center, longitudinal, observational study with eight weeks follow-up. The primary objective is to explore which biomarkers from a panel of frequ...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
July 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05315674
Start Date
July 25 2022
End Date
December 1 2025
Last Update
September 6 2023
Active Locations (1)
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1
Ciro
Horn, Limburg, Netherlands, 6085 NM