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

• Status: Completed
• Trial end date: 2019-11-04
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Indoleacetic Acids

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 <18 years

• An ACQ score ≥1.5.

• A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

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 greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin