Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:10/20/2018
Start Date:November 1, 2017
End Date:November 20, 2019
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

A randomized, multicenter, double-blind, placebo- controlled parallel-group study to
determine the efficacy and safety of QAW039, compared with placebo, when added to
standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with
uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1
second (FEV1) at the end of 12 weeks of treatment.


Inclusion Criteria:

- A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.

- Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose
ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor
antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1
and the doses have been stable for at least 4 weeks prior to Visit 1.

- FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18
years.

- Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days
of the placebo run- in period.

- Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in
period.

- Demonstrated reversible airway obstruction.

- Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion Criteria:

- Use of other investigational drugs within 5 half-lives of enrollment, or within 30
days, whichever is longer.

- A resting QTcF (Fridericia) ≥450 msec (male) or

≥460 msec (female).

- 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.

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
39
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Louisville, Kentucky 40202
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Albany, Georgia 31707
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Asheville, North Carolina 28803
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Bellevue, Nebraska 68123
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Berazategui, Buenos Aires
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Boerne, Texas 78006
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Cincinnati, Ohio 45229
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Columbia, Missouri 65212
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Dacula, Georgia 30019
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Dallas, Texas 75216
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Edmond, Oklahoma 73003
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El Paso, Texas 79902
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Eugene, Oregon 97401
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Flagstaff, Arizona 86001
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Fort Walton Beach, Florida 32547
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Fort Worth, Texas 76104
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Gastonia, North Carolina 28054
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Greenfield, Wisconsin 53228
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High Point, North Carolina 27262
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Honolulu, Hawaii 96813
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Huntington Beach, California 92647
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Long Beach, California 90813
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Los Angeles, California 90095
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McKinney, Texas 75069
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Medford, Oregon 97504
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Mission Viejo, California 92691
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Missoula, Montana 59808
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Mountain View, California 94040
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Orange, California 92868
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Overland Park, Kansas 66210
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Portland, Oregon 97228
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Rapid City, South Dakota 57701
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Rolla, Missouri 65401
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Roseville, California 95661
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Seattle, Washington 98103
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Skillman, New Jersey 08558
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Tamarac, Florida 33321
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Walnut Creek, California 94598
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Winter Park, Florida 32789
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