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:12/15/2018
Start Date:October 31, 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
42
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Warrensburg, Missouri 64093
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Altoona, Pennsylvania 16602
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Andalusia, Alabama 36420
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Ann Arbor, Michigan 48109
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Baltimore, Maryland 21287
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Birmingham, Alabama 35209
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Brooklyn, New York 11218
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Cincinnati, Ohio 45229
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Colorado Springs, Colorado 80907
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Columbia, Maryland 21044
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Columbus, Ohio 43205
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Dallas, Texas 75216
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Denver, Colorado 80262
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Goiania, GO 74110
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Kalamazoo, Michigan 49048
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Los Angeles, California 90095
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Marion, Ohio 43302
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Mayfield Heights, Ohio 44124
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Miami, Florida 33136
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Miami Gardens, Florida 33169
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Minneapolis, Minnesota 55402
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Mount Pleasant, South Carolina 29464
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Murray, Utah 84107
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New Braunfels, Texas 78130
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Newport Beach, California 92663
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Newport News, Virginia 23606
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North Dartmouth, Massachusetts 02747
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Omaha, Nebraska 68144
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Paducah, Kentucky 42003
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Pittsburgh, Pennsylvania 15224
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Raleigh, North Carolina 27609
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Rochester, Minnesota 55905
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Rolling Hills Estates, California 90274
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Saint Louis, Missouri 63128
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San Antonio, Texas 78207
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San Diego, California 92123
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San Jose, California 95117
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Spokane, Washington 99202
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Stockton, California 95204
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Tallahassee, Florida 32308
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Tulsa, Oklahoma 74104
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Winter Park, Florida 32789
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