The primary and secondary objectives of the current study are the assessments of anti-inflammatory pharmacodynamic effects on segmental endotoxin induced inflammatory response after 4 weeks treatment with BI 1026706.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Fraunhofer ITEM
Hanover, Germany
Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge
Total cell count of neutrophils in Bronchoalveolar Lavage (BAL) fluid after 24 hours of the segmental Lipopolysaccharide (LPS) challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the Least Square (LS) means obtained by fitting an Analysis of variance (ANOVA) model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Time frame: Day 29
Differential Cell Count of Neutrophils in BAL Fluid 24 h After Segmental LPS Challenge.
Differential cell count of neutrophils in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Time frame: Day 29
Total Cell Count of Eosinophil in BAL Fluid After 24 Hours of the Segmental LPS Challenge
Total cell count of eosinophil in BAL fluid after 24 hours of the segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Time frame: Day 29
Differential Cell Count of Eosinophil in BAL Fluid 24 h After Segmental LPS Challenge.
Differential cell count of eosinophil in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Time frame: Day 29
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Total Cell Count of Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge
Total cell count of monocyte in BAL fluid after 24 hours of the segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Monocyte cell count is the only cell count which was assessed by means of flow cytometry.
Time frame: Day 29
Differential Cell Count of Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.
Differential cell count of monocyte (determined by flow cytometry) in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Monocyte cell count is the only cell count which was assessed by means of flow cytometry.
Time frame: Day 29
Total Cell Count of Macrophage+Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge
Total cell count of macrophage+monocyte BAL fluid after 24 hours of the segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together.
Time frame: Day 29
Differential Cell Count of Macrophage+Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.
Differential cell count of macrophage+monocyte in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together.
Time frame: Day 29
Total Cell Count of Lymphocyte in BAL After 24 Hours of the Segmental LPS Challenge
Total cell count of lymphocyte after 24 hours of the segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Time frame: Day 29
Differential Cell Count of Lymphocyte in BAL Fluid 24 h After Segmental LPS Challenge.
Differential cell count of lymphocyte in BAL fluid 24 h after segmental LPS challenge. The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.
Time frame: Day 29