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

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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