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This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC000459 or placebo | Drug | Pills, active and/or placebo given twice daily for 17 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma quality of life questionnaire (AQLQ) | 17 weeks |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Sofia | Bulgaria | ||||
| Research site |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C571151 | (5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid |
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| Győr |
| Hungary |
| Research site | Warsaw | Poland |
| Research site | Bucharest | Romania |
| Research site | Moscow | Russia |
| Research site | Kiev | Ukraine |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |