None listed
Conditions
Interventions
150 mg of QAW039 oral tablet once a day added to conventional therapy for asthma for 156 weeks
Group name:3 Type of group
Placebo 150 mg or 450 mg of QAW039, compressed orally once a day added to conventional therapy for asthma for 156 weeks
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed Consent Form and assent if applicable. 2. Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039. 3. Patient is able to safely continue into the study as judged by the investigator.
Exclusion criteria
Exclusion criteria: 1. Patients who did not complete the Treatment Period on blinded study drug of the prior phase 3 study of QAW039 they participated in. 2. Inability to comply with all study requirements. 3. Patients who experienced a serious and drug-related AE in the prior phase 3 study of QAW039 they participated in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation of serious and non-serious adverse events Measure:Adverse events arising from treatment. Timepoints:160 Weeks ; Outcome name:Quantification of interruptions due to adverse events Measure:Interruption of treatment due to adverse event Timepoints:160 weeks ; Outcome name:Quantification by classification by organs, devices and systems Measure:Adverse event Timepoints:160 weeks ; Outcome name:Quantification of interruptions due to adverse events Measure:Interruption of treatment due to adverse event Timepoints:160 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation of adverse events Measure:Rate of patients with at least 1 Adverse Event emerging from the treatment Timepoints:160 weeks ; Outcome name:Quantification by classification by organs, devices and systems Measure:adverse events Timepoints:160 weeks ; Outcome name:Evaluation of deaths and hospitalizations Measure:Rate of deaths and hospitalizations Timepoints:160 Weeks ; Outcome name:Quantification Deaths and hospitalizations during treatment due to an asthmatic exacerbation. Measure:Deaths and hospitalizations during treatment due to an asthma exacerbation. Timepoints:160 weeks | — |
Countries
Arabia Saudi, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea South, Kuwait, Latovia, Lebano, Lithuania, Malasya, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Sweden, Switzerland, Syria, Taiwan, Turkey, United Kindgdom, United States, Vietnam
Outcome results
None listed