Chronic obstructive pulmonary disease (COPD)
Conditions
Brief summary
Exacerbation rate, Time to exacerbation
Detailed description
Duration of exacerbation, Changes in forced expiratory volume in the first second (FEV1), Changes in health-related quality of life (SGRQ score), Changes in inflammatory pathway gene expression in the PBMCs by whole transcriptome RNA-seq analysis., Changes in blood inflammatory markers (Peripheral blood leucocyte count, fibrinogen, Interleukin-6, high sensitivity C – reactive protein), Changes from baseline in pre-dose values of plethysmography (functional residual volume (FRC), inspiratory capacity (IC), transfer factor of the lung for carbon monoxide (DLCO), 6 minute walking distance (6MWD) and the rate of hospitalizations, Changes in vital signs (blood pressure, HR), and/or laboratory findings., The rate of hospitalization (pulmonary or MACE)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exacerbation rate, Time to exacerbation | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of exacerbation, Changes in forced expiratory volume in the first second (FEV1), Changes in health-related quality of life (SGRQ score), Changes in inflammatory pathway gene expression in the PBMCs by whole transcriptome RNA-seq analysis., Changes in blood inflammatory markers (Peripheral blood leucocyte count, fibrinogen, Interleukin-6, high sensitivity C – reactive protein), Changes from baseline in pre-dose values of plethysmography (functional residual volume (FRC), inspiratory capacity (IC), transfer factor of the lung for carbon monoxide (DLCO), 6 minute walking distance (6MWD) and the rate of hospitalizations, Changes in vital signs (blood pressure, HR), and/or laboratory findings., The rate of hospitalization (pulmonary or MACE) | — |
Countries
Poland