A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)
- Sponsor
- Genentech, Inc.
- Study ID
- NCT00401596
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Xolair (omalizumab) — DRUG
Study Details
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.
Key Dates
- Start date
- Jul 31, 2000
- Status verified
- Mar 2014
- Completion
- Jul 31, 2002
Study Design
- Enrollment
- 1,899 participants
- Primary purpose
- TREATMENT
Primary Outcome Measure
Incidence of all serious adverse events.
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