Last updated on January 2019

Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.


Brief description of study

This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2015) in each of the groups (patients with severe asthma and high eosinophil counts and all patients with severe asthma).

Detailed Study Description

A double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (Dose 1 and Dose 2) of QAW039 compared with placebo over a 52-week treatment period in in each of the groups (patients with severe asthma and high eosinophil counts and all patients with severe asthma). Efficacy will be measured by the rate of asthma exacerbations. In addition, asthma quality of life score, asthma control score and lung function will be assessed. Safety will be assessed by adverse event monitoring.

Clinical Study Identifier: NCT02555683

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Birmingham, AL United States

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Searcy, AR United States

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Hawaiian Gardens, CA United States

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Newport Beach, CA United States

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Westminster, CA United States

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Fort Walton Beach, FL United States

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Pensacola, FL United States

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Gainesville, GA United States

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Sunset, LA United States

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Zachary, LA United States

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Belzoni, MS United States

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Picayune, MS United States

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New York, NY United States

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Charlotte, NC United States

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Gastonia, NC United States

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Monroe, NC United States

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Winston-Salem, NC United States

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Canton, OH United States

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Maumee, OH United States

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Jefferson Hills, PA United States

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San Antonio, TX United States

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Feldkirch, Austria

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Graz, Austria

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Thalheim bei Wels, Austria

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Vienna, Austria

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Wels, Austria

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Wien, Austria

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Aalst, Belgium

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Bruxelles, Belgium

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Eghezee, Belgium

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Erpent, Belgium

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Herentals, Belgium

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Ottignies, Belgium

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Copenhagen NV, Denmark

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Tallinn, Estonia

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Tartu, Estonia

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Helsinki, Finland

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HUS, Finland

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OYS, Finland

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Tampere, Finland

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Dijon, France

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Le Kremlin Bicetre, France

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Lyon Cedex 04, France

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Paris, France

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Reims Cedex, France

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Strasbourg Cedex, France

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Berlin, Germany

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Bochum, Germany

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Frankfurt am Main, Germany

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Frankfurt, Germany

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Halle, Germany

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Hamburg, Germany

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Leipzig, Germany

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Neu Isenburg, Germany

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Ulm, Germany

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Witten, Germany

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Budapest, Hungary

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Eger, Hungary

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Gyor, Hungary

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Hajdunanas, Hungary

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Szazhalombatta, Hungary

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Hatvan, Hungary

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Komarom, Hungary

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Pecs, Hungary

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Torokbalint, Hungary

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Reykjavik, Iceland

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Daugavpils, Latvia

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Riga, Latvia

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Kaunas, Lithuania

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Klaipeda, Lithuania

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Vilnius, Lithuania

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Bialystok, Poland

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Poznan, Poland

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Timisoara, Romania

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Arad, Romania

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Singapore, Singapore

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Leicester, United Kingdom

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Plymouth, United Kingdom

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Marietta, GA United States

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Crowley, LA United States

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Bangor, ME United States

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Waldorf, MD United States

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Livonia, MI United States

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Ypsilanti, MI United States

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Bellevue, NE United States

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Omaha, NE United States

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Pittsburgh, PA United States

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East Providence, RI United States

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McKinney, TX United States

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Fairfax, VA United States

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Clayton, Australia

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Footscray, Australia

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Heidelberg, Australia

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Melbourne, Australia

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Innsbruck, Austria

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Verviers, Belgium

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Kortrijk, Belgium

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Laeken, Belgium

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Rio de Janeiro, Brazil

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Marseille, France

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Nantes, France

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Freiburg, Germany

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Landsberg, Germany

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Ciudad, Guatemala

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Guatemala City, Guatemala

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Mako, Hungary

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Bulacan, Philippines

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Manila, Philippines

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Quezon City, Philippines

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Kielce, Poland

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Ploiesti, Romania

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Brasov, Romania

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Bucharest, Romania

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Bucuresti, Romania

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Cluj Napoca, Romania

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Deva, Romania

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Sangiorgiu de Mures, Romania

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Basel, Switzerland

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Liestal, Switzerland

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Zurich, Switzerland

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Sheffield, United Kingdom

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Chertsey, United Kingdom

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Darlington, United Kingdom

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Nottingham, United Kingdom

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Wakefield, United Kingdom

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Wishaw, United Kingdom

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Ho Chi Minh, Vietnam

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Hanoi, Vietnam

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Gilbert, AZ United States

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Peoria, AZ United States

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Redondo Beach, CA United States

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Gaithersburg, MD United States

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Lincoln, NE United States

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Corning, NY United States

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Cornelius, NC United States

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New Bern, NC United States

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Whiteville, NC United States

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Cincinnati, OH United States

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Boerne, TX United States

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Bedford Park, Australia

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Tianjin, China

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Magdeburg, Germany

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Mainz, Germany

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Marburg, Germany

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Rosenheim, Germany

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Rostock, Germany

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Dublin, Ireland

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Luxembourg, Luxembourg

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Constanta, Romania

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Bragadiru, Romania

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Oradea, Romania

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Sangiorgiu De Mures, Romania

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Lugano, Switzerland

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Cardiff, United Kingdom

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Little Rock, AR United States

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New Haven, CT United States

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Wilmington, NC United States

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Caba, Argentina

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San Miguel de Tucuman, Argentina

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Buenos Aires, Argentina

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Ciudad Autonoma de Bs As, Argentina

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New Lambton Heights, Australia

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Jette, Belgium

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Sao Bernardo do Campo, Brazil

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Shijiazhuang, China

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Zhengzhou, China

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Changchun, China

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Montpellier cedex 5, France

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Schwetzingen, Germany

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Wangen, Germany

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Thessaloniki, Greece

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Biaystok, Poland

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Strzelce Opolskie, Poland

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Barcelona, Spain

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Santiago de Compostela, Spain

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St Gallen, Switzerland

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East Yorkshire, United Kingdom

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Tyne And Wear, United Kingdom

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São Paulo, Brazil

Recruitment Status: Closed


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