STER-Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
- Conditions
- Respiratory - AsthmaAsthma/ respiratoryJ45.9
- Registration Number
- LBCTR2020011378
- Lead Sponsor
- ovartis Pharmaceuticals
- Brief Summary
Please reference this link about study results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
•Written informed consent.
•Male and female patients aged more than or equal 12 years.
•A diagnosis of severe asthma, uncontrolled on GINA 4 over 5 asthma medication.
•Evidence of airway reversibility or airway hyper- reactivity.
•FEV1 less than or equal 80 percent of the predicted normal value for patients aged more than or equal 18 years; FEV1 of less than or equal 90 percent for patients aged 12 to less than 18 years
•An ACQ score more than or equal 1.5
•A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.
•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) more than or equal 450 msec (male) or more than or equal 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 more than 20 mg of simvastatin, more than 40 mg of atorvastatin, more than 40 mg of pravastatin, or more than 2 mg of pitavastatin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: Moderate-to-severe asthma exacerbations ;Timepoints: 52 weeks;Measure: 52 weeks
- Secondary Outcome Measures
Name Time Method ame: •Asthma Quality of Life Questionnaire;Timepoints: 52 weeks;Measure: 52 weeks;Name: •Pre-dose Forced Expiratory Volume in 1 second (FEV1);Timepoints: 52 weeks;Measure: 52 weeks