A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2013
End Date:February 2016

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A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy

The purpose of the study is to assess the clinical effect of QAW039 in non-atopic asthmatics
taking low dose Inhaled Corticosteroid (ICS) as background therapy.

This is a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed
to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic
and atopic asthmatics both inadequately controlled despite receiving a low dose ICS
background therapy, over a 12 week treatment period. Efficacy and safety of a once daily
dose of QAW039 is also compared with an increased dose of ICS in atopic asthmatics taking
low dose ICS as background therapy.

Inclusion Criteria:

- Written informed consent must be obtained before any assessment is performed

- Patients with a diagnosis of persistent asthma (according to Global Initiative for
Asthma 2011) for a period of at least 6 months prior to screening

- Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1)
value of 40% to 80% of individual predicted value at screening and prior to treatment

- An Asthma Control Questionnaire score ≥ 1.5 prior to treatment

- Demonstration of reversible airway obstruction

Exclusion Criteria:

- Pregnant or nursing (lactating) women

- Acute illness other than asthma at the start of the study

- Patients with clinically significant laboratory abnormalities at screening

- Patients with clinically significant condition which may compromise subject safety or
interfere with study evaluation

- Use of other investigational drugs at the time of enrollment
We found this trial at
31
sites
Colorado Springs, Colorado 80907
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Charleston, South Carolina 29407
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Charleston, SC
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Charlotte, North Carolina 28277
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Charlotte, NC
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Denver, Colorado 80262
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Denver, CO
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Denver, Colorado 80262
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Encinitas, California 92024
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Encinitas, CA
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Erpent,
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Huntington Beach, California 92647
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Huntington Beach, CA
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Lincoln, Rhode Island 02865
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Lincoln, RI
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Los Angeles, California 90095
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Los Angeles, CA
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Los Angeles, California 90095
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Los Angeles, CA
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Medford, Oregon 97504
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Medford, OR
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Minneapolis, Minnesota 55402
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Minneapolis, MN
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Mission Viejo, California 92691
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Mission Viejo, CA
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North Dartmouth, Massachusetts 02747
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North Dartmouth, MA
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Orange, California 92868
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Orange, CA
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Owensboro, Kentucky 42301
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Owensboro, KY
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Palmdale, California 93551
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Palmdale, CA
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Papillion, Nebraska 68046
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Papillion, NE
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Portland, Oregon 97228
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Riverside, California 92506
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Riverside, CA
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Rolling Hills Estates, California 90274
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San Diego, California 92123
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San Jose, California 95117
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San Jose, CA
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Sarasota, Florida 34239
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Sarasota, FL
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Seattle, Washington 98103
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Seattle, WA
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Skillman, New Jersey 08558
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Skillman, NJ
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St. Louis, Missouri 63110
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St. Louis, MO
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St. Louis, Missouri 63110
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Stockton, California 95204
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Stockton, CA
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