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
Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45229
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Colorado Springs, Colorado 80907
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Denver, Colorado 80262
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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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Lincoln, Rhode Island 02865
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Los Angeles, California 90095
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Los Angeles, California 90095
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Medford, Oregon 97504
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Minneapolis, Minnesota 55402
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Mission Viejo, California 92691
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North Dartmouth, Massachusetts 02747
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Orange, California 92868
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Owensboro, Kentucky 42301
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Palmdale, California 93551
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Papillion, Nebraska 68046
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Riverside, California 92506
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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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Sarasota, Florida 34239
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Seattle, Washington 98103
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Skillman, New Jersey 08558
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St. Louis, Missouri 63110
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St. Louis, Missouri 63110
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Stockton, California 95204
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