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The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC000459 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC000459 | Drug | OC000459 capsules 2x100mg BID for 28 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S)) | 28 days | |
| Sputum eosinophilia (subset of patients) and serum IgE | 28 days |
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Inclusion Criteria At Screening:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Pulmonology | Moscow | 105077 | Russia | |||
| Burdenko Main Military Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21762224 | Derived | Barnes N, Pavord I, Chuchalin A, Bell J, Hunter M, Lewis T, Parker D, Payton M, Collins LP, Pettipher R, Steiner J, Perkins CM. A randomized, double-blind, placebo-controlled study of the CRTH2 antagonist OC000459 in moderate persistent asthma. Clin Exp Allergy. 2012 Jan;42(1):38-48. doi: 10.1111/j.1365-2222.2011.03813.x. Epub 2011 Jul 15. |
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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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| Drug |
Placebo capsules to match OC000459 100mg capsules, 2 tablets BID |
|
| Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters | 28 days |
| Moscow |
| 105229 |
| Russia |
| City Hospital #23 | Moscow | 109240 | Russia |
| City Hospital #7 | Moscow | 115446 | Russia |
| Vishnevsky Central Military Hospital #3 | Moscow | 194354 | Russia |
| Leningrad Regional Hospital | Saint Petersbrug | 194291 | Russia |
| St George City Hospital | Saint Petersbrug | 194354 | Russia |
| St Petersburg Medical Academy of Postgraduate Education | Saint Petersburg | 190068 | Russia |
| St Petersburg Medical Academy | Saint Petersburg | 190068 | Russia |
| Outpatient Clinic #94 | Saint Petersburg | 193231 | Russia |
| St Petersbrug Hospital of the Russian Academy of Science | Saint Petersburg | 194017 | Russia |
| Russian Center of Emergency and Radiology Medicine | Saint Petersburg | 194044 | Russia |
| St Petersburg State Pediatrics Academy | Saint Petersburg | 194100 | Russia |
| Central Medical Unit #122 | Saint Petersburg | 194291 | Russia |
| St George City Hospital | Saint Petersburg | 194354 | Russia |
| Sverdlovsk Regional Hospital #1 | Yekaterinburg | 620102 | Russia |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |