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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013379-23 |
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This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of RO5036505 in patients with inadequately controlled moderate to severe asthma. Patients will be randomized to receive either RO5036505 (380mg iv infusion once weekly) or placebo for 8 weeks. Patients will be on a standardized inhaled corticosteroid/long-acting beta-agonist regimen during study treatment. Target sample size is 50-100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5036505 | Drug | 380mg iv infusion once weekly for 8 weeks |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| ACQ questionnaire, spirometry assessments, PEFR | every week up to day 95 | |
| Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters | assessed every week, laboratory parameters every 3-4 weeks, up to day 95 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance | sampling every week up to day 95 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72202 | United States | |||
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| Drug |
iv infusion once weekly for 8 weeks |
|
| San Diego |
| California |
| 92103 |
| United States |
| Denver | Colorado | 80206 | United States |
| Normal | Illinois | 61761 | United States |
| River Forest | Illinois | 60305 | United States |
| Boston | Massachusetts | 02115 | United States |
| St Louis | Missouri | 63130 | United States |
| Omaha | Nebraska | 68131 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Cleveland | Ohio | 44195 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Spartanburg | South Carolina | 29303 | United States |
| Galveston | Texas | 77555-0561 | United States |
| Madison | Wisconsin | 53792 | United States |
| Hereford | HR1 2ER | United Kingdom |
| Manchester | M23 9QZ | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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