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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001833-26 | EudraCT Number |
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| Name | Class |
|---|---|
| Atopix Therapeutics, Ltd. | INDUSTRY |
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The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma.
At week 12 subjects not on oral corticosteroids (OCS) will complete the treatment period and return after 4 weeks for final follow up visit. Those subjects who were taking OCS at baseline will continue for a maximum of 12 additional weeks, double blind period during which their current OCS treatment will be titrated down according to their clinical response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC000459 | Active Comparator | Once daily dose of 50mg OC000459 tablets orally for 12/24 weeks |
|
| Placebo | Placebo Comparator | Once daily dose of placebo tablets orally for 12/24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC000459 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effect of OC000459 50mg given once daily with placebo on the induced sputum eosinophil counts. | Mean change from baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The effect on pre- and post-bronchodilator spirometry using forced expiratory volume in one second (FEV1). | Every 4 weeks up to week 12 | |
| The effect of OC000459 on fractional exhaled nitric oxide (FeNO). | At 4,8 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Pavord, Professor | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oxford | Oxford | Oxfordshire | United Kingdom |
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| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| ID | Term |
|---|---|
| D011657 | Pulmonary Eosinophilia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
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| ID | Term |
|---|---|
| C571151 | (5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid |
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| Measuring quality of life using standardised asthma quality of life questionnaire (AQLQ(S)). | At weeks 4,8 and 12 |
| Statistical comparison from baseline on induced sputum eosinophil count. | At weeks 4,8 and 12 |
| D007960 |
| Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |