| Primary | Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes | Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points | | Posted | | Number | | Participants | | Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Primary | Number of Participants With Clinically Significant Changes in Vital Signs | Number of participants with clinically significant changes in vital signs assessed at all the listed time points | | Posted | | Number | | Participants | | Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Primary | Number of Participants With Clinically Significant Changes in ECG Variables | Number of participants with clinically significant changes in ECG variables assessed at all the listed time points | | Posted | | Number | | Participants | | Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Primary | Number of Participants With Clinically Significant Changes in Physical Examination | Number of participants with clinically significant changes in physical examination assessed at all the listed time points | | Posted | | Number | | Participants | | Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Primary | Monocytes at Baseline | Monocyte count in peripheral blood at baseline (Pre-dose, Day 1) | | Posted | | Mean | Standard Deviation | 10^9/L | | Day 1 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Primary | Monocytes at End of Treatment | Monocyte count in peripheral blood at end of treatment (4 weeks) | | Posted | | Mean | Standard Deviation | 10^9/L | | week 4 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Primary | Monocytes at Follow-up | Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment) | | Posted | | Mean | Standard Deviation | 10^9/L | | week 5 (follow-up) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Morning FEV1 at Baseline | Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible. | | Posted | | Mean | Standard Deviation | L | | Average of 10 days of pre-treatment measurements (day -10 to -1) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Morning FEV1 During Last 7 Days of Treatment | Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible. | | Posted | | Mean | Standard Deviation | L | | Average of the last 7 days of treatment (week 4) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Evening FEV1 at Baseline | Measurement conducted by patient in evening. | | Posted | | Mean | Standard Deviation | L | | Average of 10 days of pre-treatment measurements (day -10 to -1) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Evening FEV1 During Last 7 Days of Treatment | Measurement conducted by patient in evening. | | Posted | | Mean | Standard Deviation | L | | Average of the last 7 days of treatment (week 4) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Morning Peak Expiratory Flow (PEF) at Baseline | Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible. | | Posted | | Mean | Standard Deviation | L/minute | | Average of 10 days of pre-treatment measurements (day -10 to -1) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Morning PEF During Last 7 Days of Treatment | Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible. | | Posted | | Mean | Standard Deviation | L/minute | | Average of the last 7 days of treatment (week 4) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Evening PEF at Baseline | Measurement conducted by patient in evening. | | Posted | | Mean | Standard Deviation | L/minute | | Average of 10 days of pre-treatment measurements (day -10 to -1) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Evening PEF During Last 7 Days of Treatment | Measurement conducted by patient in evening. | | Posted | | Mean | Standard Deviation | L/minute | | Average of the last 7 days of treatment (week 4) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline | The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation). Baseline is the mean value over the 7 days prior to randomisation. | | Posted | | Mean | Standard Deviation | Units on scale, 0-100 | | Average of 7 days of pre-treatment measurements (day -7 to -1) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | EXACT Total Score During Last 7 Days of Treatment | The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation). | | Posted | | Mean | Standard Deviation | Units on scale, 0-100 | | Average of the last 7 days of treatment (week 4) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline | The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units. Baseline is mean of 10 days prior to treatment. | | Posted | | Mean | Standard Deviation | Units on scale, 0-12 | | Average of 10 days of pre-treatment measurements (day -10 to -1) | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | BCSS (Evening) Total Score During Last 7 Days of Treatment | The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units. | | Posted | | Mean | Standard Deviation | Units on scale, 0-12 | | Average of the last 7 days of treatment (week 4) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Rescue Medication Use During the Last 7 Days of Treatment | Number of inhalations of short acting β2 agonist (SABA) or short acting muscarinic antagonist (SAMA) per day. | | Posted | | Mean | Full Range | Inhalations | | Average of the last 7 days of treatment (week 4) | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | St George's Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline | The SGRQ-C includes 40 questions in 3 domains: Symptoms (distress due to respiratory symptoms, 7 questions), Activity (disturbance of physical activity, 13 questions), Impacts (overall impact on daily life and well-being, 20 questions). Scores are expressed as a percentage. Baseline is Day 1. | | Posted | | Mean | Standard Deviation | Percent of maximum possible score | | Day 1 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | SGRQ Total Score at End of Treatment | Decrease in score represents improved Quality of Life; increase represents deteriorated Quality of Life. An increase or decrease of 4 or more percent units is judged as the Minimal Clinically Important Difference. | | Posted | | Mean | Standard Deviation | Percent of maximum possible score | | week 4 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline | Baseline = Day 1 = Visit 2 | | Posted | | Geometric Mean | Full Range | pg/mL | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | CCL2 Concentration in Plasma at End of Treatment | End of treatment = 4 weeks = Visit 6 | | Posted | | Geometric Mean | Full Range | pg/mL | | week 4 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Serum Amyloid-A (SAA) Concentration in Plasma at Baseline | Baseline = Day 1 = Visit 2 | | Posted | | Geometric Mean | Full Range | ng/mL | | Day 1 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | SAA Concentration in Plasma at End of Treatment | End of treatment = 4 weeks = Visit 6 | | Posted | | Geometric Mean | Full Range | ng/mL | | week 4 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State | PK-model: 1-compartment population model with first order absorption. AUC was estimated at steady state | | Posted | | Geometric Mean | Full Range | nmol*h/L | | 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State | PK-model: 1-compartment population model with first order absorption. Cmaxwas estimated at steady state | | Posted | | Geometric Mean | Full Range | nmol/L | | 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State | PK-model: 1-compartment population model with first order absorption. tmax was estimated at steady state | | Posted | | Median | Full Range | Hours | | 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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| Secondary | Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State | PK-model: 1-compartment population model with first order absorption. (Vss/F) was estimated at steady state | | Posted | | Geometric Mean | Full Range | L | | 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4 | | | | ID | Title | Description |
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| OG000 | AZD2423 100 mg | Two 50 mg AZD2423 tablets, once daily for 28 days | | OG001 | Placebo | Placebo to match AZD2423 50 mg tablets, once daily for 28 days |
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