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This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Omalizumab 900 mg |
|
| 2 | Experimental | Omalizumab 1050 mg |
|
| 3 | Experimental | Omalizumab 1200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug |
|
| |
| Omalizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of omalizumab assessed by AEs and SAEs |
| Measure | Description | Time Frame |
|---|---|---|
| - Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis investigative site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | Germany | ||||
| Novartis Investigative site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24657236 | Derived | Kornmann O, Watz H, Fuhr R, Krug N, Erpenbeck VJ, Kaiser G. Omalizumab in patients with allergic (IgE-mediated) asthma and IgE/bodyweight combinations above those in the initially approved dosing table. Pulm Pharmacol Ther. 2014 Aug;28(2):149-53. doi: 10.1016/j.pupt.2014.03.003. Epub 2014 Mar 18. |
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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 |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Drug |
|
|
| Omalizumab | Drug |
|
|
| Hamburg |
| Germany |
| Novartis investigative site | Hanover | Germany |
| Novartis investigative site | Mainz | Germany |
| Novartis Investigative site | Bloemfontein | South Africa |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |