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Completed NCT02555683

Efficacy and Safety Study of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

Conditions: Asthma

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 894
Sponsor: Novartis Pharmaceuticals

Location: Novartis Investigative Site Birmingham Alabama

Summary

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: * patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) * patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

Eligibility Criteria

Inclusion Criteria: * Written informed consent and assent (if applicable). * Male and female patients aged ≥12 years (or ≥lower age limit allowed by health authority and/or ethics committee/institutional review board approvals). * A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication. * Evidence of airway reversibility or airway hyper- reactivity. * FEV1 of ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02555683). StuddyBuddy aggregates publicly available trial information.