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This study is designed to investigate the safety and tolerability of multiple doses of QAX576 in controlled or partially controlled asthma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QAX576 1 mg/kg | Active Comparator |
| |
| QAX576 3 mg/kg | Active Comparator |
| |
| QAX576 10 mg/kg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAX576 | Drug |
| ||
| QAX576 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Assessing and comparing the safety and tolerability of multiple doses of QAX576 in controlled and partially controlled asthma patients. | 120 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the pharmacokinetics of multiple doses of QAX576 in asthmatics | 120 Days | |
| Assessing the effect of QAX576 on asthma control using assessments such as exhaled NO, FEV1 variability data captures by PIKO-1 home monitoring device and the extent of inhaled salbutamol use as rescue medication. |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Moscow | Russia | ||||
| Novartis Investigator Site |
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| Label | URL |
|---|---|
| Results for CQAX576A2107 can be found on the Novartis Clinical Trial Results Website | View source |
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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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|
| QAX576 | Drug |
|
| Placebo | Drug |
|
| 120 Days |
| Saint Petersburg |
| Russia |
| Novartis Investigator Site | Manchester | United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |