Dose Finding Study for QAW039 in Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:August 2011
End Date:November 2013

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A Randomized, Placebo-controlled, Dose-ranging, Multi-centre Trial of QAW039 (1-450 mg p.o.), to Investigate the Effect on FEV1 and ACQ in Patients With Moderate-to-severe, Persistent, Allergic Asthma, Inadequately Controlled With ICS Therapy.

This study aims to demonstrate a clinically significant improvement in Forced Expiratory
Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately
controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an
active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging,
multi-centre trial.


Inclusion Criteria: - Physician diagnosis of asthma, as per the Global Initiative for
Asthma (GINA) (2009) guidelines, and currently prescribed Inhaled Corticosteroids (ICS)
therapy. - Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)
value of 40% to 80% of individual predicted value. - Patients should be allergic or
atopic, as diagnosed historically or prior to entry into the study. - Patients who are
demonstrated to have reversible airway obstruction or airways hyper-reactivity or have
shown either of such responses in previous test(s) within the last year. - An Asthma
Control Questionnaire (ACQ) score ≥ 1.5 at randomization. Exclusion Criteria: - Pregnant
or nursing (lactating) women, where pregnancy is defined as the state of a female after
conception and until the termination of gestation, confirmed by a positive human chorionic
gonadotropin (hCG) laboratory test (> 5 mIU/mL). - Patients with serious co-morbidities
including uncontrolled diabetes (HbA1c≥8%), heart failure, cancer, neurodegenerative
diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases
including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other
conditions characterized by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss
syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.). - Acute
illness other than asthma at the start of the study - History of life-threatening asthma,
including a history of significant hypercarbia (pCO2>45mmHg), prior intubation,
respiratory arrest, or seizures as a result of asthma. - Patients who have had a
respiratory tract infection within 4 weeks of the screening visit. Patients who develop a
respiratory tract infection between screening and the randomization visit must be screen
failed, and may be permitted to re-enroll at a later date. - Current smokers or ex-smokers
who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10
pack years. Other protocol-defined inclusion/exclusion criteria apply.
We found this trial at
39
sites
Omaha, Nebraska 68144
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Omaha, NE
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Bangor, Maine 04401
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Bangor, ME
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Caba, Buenos Aires
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Caba,
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Canton, Ohio 44718
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Canton, OH
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Centennial, Colorado 80112
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Centennial, CO
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Charleston, South Carolina 29407
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Charleston, SC
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Columbus, Ohio 43205
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Columbus, OH
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Dallas, Texas 75216
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Dallas, TX
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Denver, Colorado 80262
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Denver, CO
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Encinitas, California 92024
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Encinitas, CA
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Erie, Pennsylvania 16506
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Erie, PA
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Fort Worth, Texas 76104
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Fort Worth, TX
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Huntington Beach, California 92647
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Huntington Beach, CA
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Lake Oswego, Oregon 97035
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Lake Oswego, OR
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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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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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North Dartmouth, Massachusetts 02747
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North Dartmouth, MA
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Oklahoma City, Oklahoma 73104
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from
Oklahoma City, OK
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Omaha, Nebraska 68144
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from
Omaha, NE
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Orange, California 92868
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Orange, CA
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Papillion, Nebraska 68046
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Papillion, NE
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River Forest, Illinois 60305
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River Forest, IL
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Riverside, California 92506
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Riverside, CA
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San Diego, California 92123
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San Diego, CA
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San Diego, California 92123
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San Diego, CA
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San Jose, California 95117
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San Jose, CA
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San Mateo, California 94401
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San Mateo, CA
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Sarasota, Florida 34239
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Sarasota, FL
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Savannah, Georgia 31406
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Savannah, GA
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Scottsdale, Arizona 85251
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Scottsdale, AZ
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Skillman, New Jersey 08558
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Skillman, NJ
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South Burlington, Vermont 05403
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South Burlington, VT
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St. Louis, Missouri 63110
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St. Louis, MO
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Stockton, California 95204
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Stockton, CA
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Waco, Texas 76710
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Waco, TX
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Warrensburg, Missouri 64093
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Warrensburg, MO
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Wheaton, Maryland 20902
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Wheaton, MD
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