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This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADC3680B oral | Experimental |
| |
| Placebo oral | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADC3680B oral | Drug | Once daily for 28 days |
| |
| Placebo oral |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability | Baseline to Day 35 | |
| Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety | Baseline to Day 35 | |
| Evaluation of the change in vital signs as a measure of safety | Baseline to Day 35 | |
| Evaluation of the change in Pulmonary function as a measure of safety and tolerability | Baseline to Day 35 | |
| Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of concentrations of ADC3680B in plasma | Days 1-2 and Days 28-30 | |
| Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood | Day 1 and Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast | BT9 6AD | United Kingdom | ||||
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| Drug |
Once daily for 28 days |
|
| Manchester |
| M23 9QZ |
| United Kingdom |