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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00401596 |
This was a multicenter, open label, randomized, controlled, safety trial in subjects aged 6-75 years with a diagnosis of moderate to severe, persistent asthma. A total of 1899 subjects were randomized (2:1) to either the active treatment group or the control group. Upon successful completion of the screening period (~2 weeks), each subject entered the 24 week study.
Condition | Intervention | Phase |
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Asthma |
Drug: Xolair (omalizumab) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Multicenter, Randomized, Controlled, Open-Label Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Subjects Already Treated With Other Therapies (ALTO) |
Estimated Enrollment: | 1899 |
Ages Eligible for Study: | 6 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Q2143g |
Study First Received: | November 17, 2006 |
Last Updated: | November 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00401596 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ALTO |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Omalizumab Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |