| Primary | Absolute Monocyte Count in BAL Post-LPS Challenge | Monocyte count in BAL post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000398± 1.276
- OG001514.4± 1.284
|
|
| |
| Secondary | Total Neutrophils in Biopsy Sample (Post-LPS Challenge) | Pre-challenge = Day 11. Biopsies taken from left lingula. Cells counted in subepithelium. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations. | Posted | | Least Squares Mean | Standard Error | cells/mm^2 | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Total Macrophages in Biopsy Sample (Post-LPS Challenge) | Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations. | Posted | | Least Squares Mean | Standard Error | cells/mm^2 | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | CD45+ in Biopsy Sample (Post-LPS Challenge) | Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations. | Posted | | Least Squares Mean | Standard Error | cells/mm^2 | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | CD3+ in Biopsy Sample (Post-LPS Challenge) | Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations. | Posted | | Least Squares Mean | Standard Error | cells/mm^2 | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Biopsy PAS Reaction Grade (Post-LPS Challenge) | Biopsies stained using PAS method. Graded on subjective scale (1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells). | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Biopsy Epithelium Grade (Post-LPS Challenge) | Biopsies (from right middle lobe) were assessed for routine histopathology. Epithelial morphology was graded on subjective scale from 1 to 5. 1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Eosinophils in BAL (Post-LPS Challenge) | Post-LPS challenge eosinophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations. | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Lymphocytes in BAL (Post-LPS Challenge) | Post-LPS challenge lymphocyte differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Neutrophils in BAL (Post-LPS Challenge) | Post-LPS challenge neutrophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Macrophages in BAL (Post-LPS Challenge) | Post-LPS challenge macrophage differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Deviation | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | TNF α Concentration in BAL (Post-LPS Challenge) | Post-LPS challenge TNF α concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations. | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | CCL2 Concentration in BAL (Post-LPS Challenge) | Post-LPS challenge CCL2 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations. | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | IL-1β Concentration in BAL (Post-LPS Challenge) | Post-LPS challenge IL-1β concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations. | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | IL-6 Concentration in BAL (Post-LPS Challenge) | Post-LPS challenge IL-6 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations. | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | IL-8 Concentration in BAL (Post-LPS Challenge) | Post-LPS challenge IL 8 concentration in BAL. LPS challenge and post-LPS challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations. | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | RANTES Concentration in BAL (Post-LPS Challenge) | Post-LPS challenge RANTES concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations. | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | SP-D Concentration in BAL (Post-LPS Challenge) | Post-LPS challenge SP-D concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations. | Posted | | Least Squares Mean | Standard Error | ng/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | SAA Concentration in Blood (Pre-LPS Challenge) | SAA concentration in blood pre-LPS challenge (Day 10). | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | ng/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | SAA Concentration in Blood (Post-LPS Challenge) | SAA concentration in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | ng/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | CCL2 Concentration in Blood (Pre-LPS Challenge) | CCL2 concentration in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | CCL2 Concentration in Blood (Post-LPS Challenge) | CCL2 concentration in blood post-LPS challenge (Day 11). | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | IL-1β Concentration in Blood (Pre-LPS Challenge) | IL-1β concentration in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | IL-1β Concentration in Blood (Post-LPS Challenge) | IL-1β concentration in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | IL-6 Concentration in Blood (Pre-LPS Challenge) | IL-6 concentration in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | IL-6 Concentration in Blood (Post-LPS Challenge) | IL-6 concentration in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | IL-8 Concentration in Blood (Pre-LPS Challenge) | IL-8 concentration in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | IL-8 Concentration in Blood (Post-LPS Challenge) | IL-8 concentration in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | TNF-α Concentration in Blood (Pre-LPS Challenge) | TNF-α concentration in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | TNF-α Concentration in Blood (Post-LPS Challenge) | TNF-α concentration in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | pg/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | SP-D Concentration in Blood (Pre-LPS Challenge) | SP-D concentration in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | ng/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | SP-D Concentration in Blood (Post-LPS Challenge) | SP-D concentration in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | ng/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | CC16 Concentration in Blood (Pre-LPS Challenge) | CC16 concentration in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Three patients had missing observations. | Posted | | Least Squares Mean | Standard Error | ng/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | CC16 Concentration in Blood (Post-LPS Challenge) | CC16 concentration in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations. | Posted | | Least Squares Mean | Standard Error | ng/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Basophils in Blood (Pre-LPS Challenge) | Basophils in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Basophils in Blood (Post-LPS Challenge) | Basophils in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Eosinophils in Blood (Pre-LPS Challenge) | Eosinophils in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Eosinophils in Blood (Post-LPS Challenge) | Eosinophils in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Lymphocytes in Blood (Pre-LPS Challenge) | Lymphocytes in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Lymphocytes in Blood (Post-LPS Challenge) | Lymphocytes in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Monocytes in Blood (Pre-LPS Challenge) | Monocytes in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Monocytes in Blood (Post-LPS Challenge) | Monocytes in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Neutrophils in Blood (Pre-LPS Challenge) | Neutrophils in blood pre-LPS challenge (Day 10) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 10 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Neutrophils in Blood (Post-LPS Challenge) | Neutrophils in blood post-LPS challenge (Day 11) | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | x10^4 cells/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State | Steady state pharmacokinetic (PK) profile measured on Day 10 | All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE. | Posted | | Geometric Mean | Full Range | nmol/L | | Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Time to Cmax (Tmax) of AZD2423 at Steady State | Steady state PK profile measured on Day 10 | All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE. | Posted | | Median | Full Range | hours | | Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State | Steady state PK profile measured on Day 10 | All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE. | Posted | | Geometric Mean | Full Range | nmol*h/L | | Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State | Steady state PK profile measured on Day 10 | All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE. | Posted | | Geometric Mean | Full Range | nmol*h/L | | Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes | | | Posted | | Number | | Participants | | up to 47 days (visit 1 to visit 6) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Number of Participants With Clinically Relevant Changes in Vital Signs | | | Posted | | Number | | Participants | | up to 47 days (visit 1 to visit 6) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables | | | Posted | | Number | | Participants | | up to 47 days (visit 1 to visit 6) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Number of Participants With Clinically Relevant Changes in Physical Examination | | | Posted | | Number | | Participants | | up to 47 days (visit 1 to visit 6) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | Number of Participants With Treatment-related or Clinically Relevant Changes in Spirometry (Forced Expiratory Volume in 1 Second [FEV1], Forced Vital Capacity [FVC] Pre-bronchodilator) | | | Posted | | Number | | Participants | | up to 47 days (visit 1 to visit 6) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |
| Secondary | CC16 Concentration in BAL (Post-LPS Challenge) | Post-LPS challenge CC16 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe. | Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge | Posted | | Least Squares Mean | Standard Error | ng/mL | | Day 11 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 | Two 50 mg AZD2423 tablets, once daily | | OG001 | Placebo | Placebo to match AZD2423 tablets, once daily |
| |