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



Status:Active, not recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:10/7/2018
Start Date:December 3, 2015
End Date:September 19, 2019

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A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.

This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared
with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA
2015) in each of the groups (patients with severe asthma and high eosinophil counts and all
patients with severe asthma)

A double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses
(Dose 1 and Dose 2) of QAW039 compared with placebo over a 52-week treatment period in in
each of the groups (patients with severe asthma and high eosinophil counts and all patients
with severe asthma). Efficacy will be measured by the rate of asthma exacerbations. In
addition, asthma quality of life score, asthma control score and lung function will be
assessed. Safety will be assessed by adverse event monitoring.

Inclusion Criteria:

- Written informed consent.

- Male and female patients aged ≥12 years.

- A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.

- Evidence of airway reversibility or airway hyper- reactivity.

- FEV1 ≤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 >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or
>2 mg of pitavastatin.
We found this trial at
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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