A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)
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.
|Study Design:||Primary Purpose: 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)|
- Incidence of all serious adverse events.
- Incidence of all adverse events during the treatment phase of the study
- Incidence of protocol defined asthma exacerbation episodes (AEEs) during the treatment phase of the study
- Nocturnal symptoms as measured by the modified Inner City Asthma Study Morbidity Assessment.
|Study Start Date:||July 2000|
|Study Completion Date:||July 2002|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401596
|Study Director:||Yamo Deniz, M.D.||Genentech|