asthma N/A
Conditions
Interventions
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: -Written informed consent. -WW: Male and female patients aged >=12 years (or lower age limit allowed by health authority and/or ethics committee/instutitional review board approvals). NLD: Male and female patients aged >=18 years. -A diagnosis of asthma (according to GINA 2015) for a period of at least 24 months prior to Visit 1. - WW: For patients aged >= 18 years: FEV1 =1.5 at Visit 1. - A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.;Other inclusion criteria apply. See protocol for full details.
Exclusion criteria
Exclusion criteria: -Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer. -Subjects who have participated in another trial of QAW039. -A QTcF (Fridericia) >=450 msec (male) or >=460 msec (female). -History of malignancy with the exception of local basal cell carcinoma of the skin. -Pregnant or nursing (lactating) women. -Serious co-morbidities. -Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, and >2 mg of pitavastatin.;Other exclusion criteria apply. See protocol for full details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary variable for this study is the number of moderate-to-severe asthma exacerbations experienced by each patient per patient year of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary variables of this trial are AQLQ+12, ACQ-5 and average of the two pre-dose FEV1 assessments at the end of the 52 week treatment period. | — |
Countries
Argentina, Canada, Czechia, Egypt, Greece, India, Israel, Italy, Japan, Korea (the Democratic Peoples Republic of), Korea (the Republic of), Lebanon, Malaysia, Mexico, Netherlands, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan (Province of China), United States of America
Outcome results
None listed