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

A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

• patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)
• patients with inadequately controlled severe asthma (overall study population)

Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: QAW039; Drug: QAW039

Detailed Description

This study used a randomized, multicenter, double-blind, placebo-controlled parallel-group design in which QAW039 150 mg or QA039 450 mg or placebo was added to standard of care, GINA steps 4 and 5 asthma therapy.

The study included:

• Screening period of up to 2 weeks to assess eligibility;
• Run-in period of approximately 2 weeks and a maximum of 6 weeks on placebo to collect baseline data for efficacy variables and compliance with the Electronic Peak Flow/ eDiary device. Upon completion of the run-in period, all patients who met the eligibility criteria were randomized to one of three treatments: QAW039 150 mg or QAW039 450 mg or placebo once daily in a ratio of 1:1:1.
• Treatment period of 52 weeks (assessment period for all Primary and Secondary Outcome Measures). Clinic visits were scheduled approximately 4 weeks after randomization and then at approximately 8-week intervals during the active-treatment period. Phone calls occurred at specified time points between visits occurring at 8-week intervals. Patients who had successfully completed 52 weeks of treatment in this study were offered an optional participation in a safety study (CQAW039A2315).
• Follow-up period of 4 weeks, investigational and drug-free, following the last dose of study drug. A follow-up visit occurred approximately 4 weeks (i.e., approximately 30 days) following the last dose of study therapy to complete safety assessments and pregnancy testing (if applicable). the follow-up period applied to all patients except those patients who had entered the safety study (CQAW039A2315) directly after the Week 52 study visit.

• Study Type: Interventional
• Enrollment (Actual): 894
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1012AAR
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  • Ciudad Autonoma de Bs As, Argentina, C1425FVH
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  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1425BEN
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  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
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• Australia
  • South Australia
    • Bedford Park, South Australia, Australia, 5041
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  • Victoria
    • Clayton, Victoria, Australia, 3168
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    • Footscray, Victoria, Australia, 3011
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    • Heidelberg, Victoria, Australia, 3084
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    • Melbourne, Victoria, Australia, 3004
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• Austria
  • Amstetten, Austria, 3300
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  • Feldkirch, Austria, 6800
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  • Graz, Austria, 8036
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  • Thalheim bei Wels, Austria, 4600
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  • Vienna, Austria, A-1130
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  • Wien, Austria, A 1090
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  • Wien, Austria, A-1140
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  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
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• Belgium
  • Aalst, Belgium, 9300
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  • Brussel, Belgium, 1020
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  • Bruxelles, Belgium, 1000
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  • Bruxelles, Belgium, 1160
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  • Eghezee, Belgium, 5310
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  • Erpent, Belgium, 5100
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  • Herentals, Belgium, 2200
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  • Kortrijk, Belgium, 8500
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  • Liege, Belgium, 4000
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  • Ottignies, Belgium, 1340
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  • Limburg
    • Genk, Limburg, Belgium, 3600
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• Brazil
  • Porto Alegre RS
    • Porto Alegre, Porto Alegre RS, Brazil, 90610 000
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  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941-590
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  • RS
    • Porto Alegre, RS, Brazil, 90020-090
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  • SC
    • Florianopolis, SC, Brazil, 88040-970
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  • SP
    • Sao Bernardo do Campo, SP, Brazil, 09715 090
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    • Sao Paulo, SP, Brazil, 05403 000
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    • Sao Paulo, SP, Brazil, 05437 010
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    • Sao Paulo, SP, Brazil, 04023-900
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  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89030101
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• China
  • Beijing, China, 100050
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  • Chengdu, China, 610083
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  • Chongqing, China, 400037
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  • Shanghai, China, 200433
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  • Tianjin, China, 300052
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  • Guang Dong Province
    • Guang Zhou, Guang Dong Province, China, 510120
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  • Hainan
    • Haikou, Hainan, China, 570311
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  • Hebei
    • Shijiazhuang, Hebei, China, 050000
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  • Hubei
    • Wuhan, Hubei, China, 430030
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  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
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    • Nanjing, Jiangsu, China, 210009
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  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
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  • Jilin
    • Chang Chun, Jilin, China, 130021
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  • Liaoning
    • Shenyang, Liaoning, China, 110000
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    • Shenyang, Liaoning, China, 110003
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  • Shanxi
    • Xian, Shanxi, China, 710061
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  • Sichuan
    • Chengdu, Sichuan, China, 610041
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  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
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• Denmark
  • Copenhagen NV, Denmark, 2400
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• Estonia
  • Tallinn, Estonia, 13419
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  • Tallinn, Estonia, 13619
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  • Tartu, Estonia, 51014
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• Finland
  • HUS, Finland, 00029
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  • Helsinki, Finland, 00290
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  • OYS, Finland, FIN-90029
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  • Tampere, Finland, 33520
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• France
  • Dijon, France, 21000
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  • Le Kremlin Bicetre, France, 94275
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  • Lyon Cedex 04, France, 69317
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  • Marseille, France, 13015
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  • Nantes, France, 44093
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  • Paris, France, 75018
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  • Reims Cedex, France, 51092
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  • Strasbourg Cedex, France, 67091
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  • Herault
    • Montpellier cedex 5, Herault, France, 34059
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• Germany
  • Berlin, Germany, 12203
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  • Berlin, Germany, 10717
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  • Berlin, Germany, 12627
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  • Berlin, Germany, 10969
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  • Frankfurt, Germany, 60596
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  • Frankfurt, Germany, 60313
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  • Frankfurt, Germany, 60389
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  • Halle, Germany, 06108
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  • Hamburg, Germany, 20354
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  • Landsberg, Germany, 86899
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  • Leipzig, Germany, 04357
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  • Leipzig, Germany, 04103
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  • Magdeburg, Germany, 39120
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  • Mainz, Germany, 55131
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  • Marburg, Germany, D-35037
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  • Neu Isenburg, Germany, 63263
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  • Rosenheim, Germany, 83026
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  • Rostock, Germany, 18057
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  • Rudersdorf, Germany, 15562
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  • Witten, Germany, 58452
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  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69126
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• Greece
  • GR
    • Thessaloniki, GR, Greece, 570 10
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• Guatemala
  • Guatemala City, Guatemala, 01010
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  • Guatemala City, Guatemala, 01011
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  • GTM
    • Guatemala City, GTM, Guatemala, 01010
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    • Guatemala City, GTM, Guatemala, 01011
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  • Gautemala
    • Ciudad, Gautemala, Guatemala, 01010
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• Hungary
  • Komarom, Hungary, 2900
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  • Pecs, Hungary, 7635
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  • HUN
    • Eger, HUN, Hungary, 3300
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    • Gyor, HUN, Hungary, 9024
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    • Hajdunanas, HUN, Hungary, 4080
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    • Mako, HUN, Hungary, 6900
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    • Szazhalombatta, HUN, Hungary, 2440
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  • Pest
    • Torokbalint, Pest, Hungary, 2045
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• Iceland
  • Reykjavik, Iceland, 109
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• Ireland
  • Dublin, Ireland, 24
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  • Dublin, Ireland, DUBLIN 8
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• Latvia
  • Daugavpils, Latvia, LV-5417
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  • Daugavpils, Latvia, LV-5401
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  • Riga, Latvia, LV 1002
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• Lithuania
  • Kaunas, Lithuania, LT-45130
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  • Klaipeda, Lithuania, LT-92231
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  • LT
    • Kaunas, LT, Lithuania, LT-50128
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  • LTU
    • Kaunas, LTU, Lithuania, LT 50161
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    • Klaipeda, LTU, Lithuania, LT-93220
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    • Vilnius, LTU, Lithuania, LT-10207
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    • Vilnius, LTU, Lithuania, LT-05263
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    • Vilnius, LTU, Lithuania, LT-08406
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• Philippines
  • Bulacan, Philippines, 3020
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  • Manila, Philippines, 1000
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  • Quezon City, Philippines, 1100
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• Poland
  • Bialystok, Poland, 15-010
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  • Bialystok, Poland, 15 276
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  • Biaystok, Poland, 15-430
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  • Poznan, Poland, 60-693
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  • Poznan, Poland, 60-214
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  • Poznan, Poland, 60-823
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  • Strzelce Opolskie, Poland, 47 100
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  • POL
    • Kielce, POL, Poland, 25-371
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• Romania
  • Arad, Romania, 310013
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  • Bragadiru, Romania, 077025
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  • Brasov, Romania, 500051
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  • Brasov, Romania, 500086
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  • Brasov, Romania, 500283
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  • Brasov, Romania, 500366
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  • Bucharest, Romania, 030317
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  • Bucuresti, Romania, 050554
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  • Cluj Napoca, Romania, 400139
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  • Cluj Napoca, Romania, 400371
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  • Deva, Romania, 330162
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  • Oradea, Romania, 410176
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  • Sangiorgiu De Mures, Romania, 547530
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  • Prahova
    • Ploiesti, Prahova, Romania, 100024
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  • ROM
    • Constanta, ROM, Romania, 900412
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  • Timis
    • Timisoara, Timis, Romania, 300310
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• Singapore
  • Singapore, Singapore, 529889
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  • Singapore, Singapore, 169608
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  • SGP
    • Singapore, SGP, Singapore, 117599
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• Spain
  • Barcelona, Spain, 08006
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• Switzerland
  • Basel, Switzerland, 4031
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  • Liestal, Switzerland, 4410
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  • Lugano, Switzerland, 6900
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  • St Gallen, Switzerland, 9007
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  • Zurich, Switzerland, 8032
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• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
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  • Birmingham, United Kingdom, B15 2WB
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  • Cardiff, United Kingdom, CF14 4XW
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  • Chertsey, United Kingdom, KT16 0PZ
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  • East Yorkshire, United Kingdom, HU16 5JQ
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  • Leicester, United Kingdom, LE3 9QP
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  • Nottingham, United Kingdom, NG5 1PB
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  • Plymouth, United Kingdom, PL6 8DH
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  • Tyne And Wear, United Kingdom, NE29 8NH
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  • Wakefield, United Kingdom, WF1 4DG
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  • Wishaw, United Kingdom, ML2 0DP
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  • Cambrigdeshire
    • Cambridge, Cambrigdeshire, United Kingdom, CB2 0QQ
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  • Durham
    • Darlington, Durham, United Kingdom, DL3 6HX
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  • GBR
    • London, GBR, United Kingdom, EC1M 6BQ
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  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
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  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
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• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
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    • Birmingham, Alabama, United States, 35249
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  • Arizona
    • Gilbert, Arizona, United States, 85234
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    • Litchfield Park, Arizona, United States, 85340
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    • Peoria, Arizona, United States, 85381
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  • Arkansas
    • Little Rock, Arkansas, United States, 72209
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  • California
    • Hawaiian Gardens, California, United States, 90716
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    • Newport Beach, California, United States, 92663
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    • Redondo Beach, California, United States, 90277
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    • Riverside, California, United States, 92506
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    • Torrance, California, United States, 90503
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    • Westminster, California, United States, 92683
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  • Connecticut
    • New Haven, Connecticut, United States, 06520
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  • Florida
    • Brandon, Florida, United States, 33511
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    • New Smyrna Beach, Florida, United States, 32168
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    • Orlando, Florida, United States, 32806
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    • Orlando, Florida, United States, 32803
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    • Ormond Beach, Florida, United States, 32174
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    • Sebring, Florida, United States, 33870
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    • Winter Park, Florida, United States, 32789
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  • Georgia
    • Gainesville, Georgia, United States, 30501
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    • Marietta, Georgia, United States, 30060
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  • Louisiana
    • Crowley, Louisiana, United States, 70526
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    • Zachary, Louisiana, United States, 70791
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  • Maine
    • Bangor, Maine, United States, 04401
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  • Maryland
    • Gaithersburg, Maryland, United States, 20878
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    • White Marsh, Maryland, United States, 21162
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  • Michigan
    • Livonia, Michigan, United States, 48152
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    • Ypsilanti, Michigan, United States, 48197
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  • Mississippi
    • Picayune, Mississippi, United States, 39466
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  • Nebraska
    • Bellevue, Nebraska, United States, 68123
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    • Lincoln, Nebraska, United States, 68510
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    • Omaha, Nebraska, United States, 68131
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  • New York
    • Corning, New York, United States, 14830
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    • New York, New York, United States, 10016
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  • North Carolina
    • Charlotte, North Carolina, United States, 28277
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    • Gastonia, North Carolina, United States, 28054
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    • Monroe, North Carolina, United States, 28112
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    • New Bern, North Carolina, United States, 28562
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    • Whiteville, North Carolina, United States, 28472
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    • Wilmington, North Carolina, United States, 28401
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    • Winston-Salem, North Carolina, United States, 27103
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  • Ohio
    • Canton, Ohio, United States, 44718
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    • Cincinnati, Ohio, United States, 45231
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    • Maumee, Ohio, United States, 43537
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
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  • Pennsylvania
    • Jefferson Hills, Pennsylvania, United States, 15025
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    • Pittsburgh, Pennsylvania, United States, 15213
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  • Rhode Island
    • East Providence, Rhode Island, United States, 02941
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  • Texas
    • Boerne, Texas, United States, 78006
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    • McKinney, Texas, United States, 75069
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    • Plano, Texas, United States, 75093
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    • San Antonio, Texas, United States, 78229
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    • San Antonio, Texas, United States, 78251
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  • Virginia
    • Fairfax, Virginia, United States, 22030
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• Vietnam
  • Hanoi, Vietnam, 100000
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  • Ho Chi Minh, Vietnam, 700000
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  • VNM
    • Ho Chi Minh, VNM, Vietnam, 700000
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent and assent (if applicable).
• Male and female patients aged ≥12 years (or ≥lower age limit allowed by health authority and/or ethics committee/institutional review board approvals).
• A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
• Evidence of airway reversibility or airway hyper- reactivity.
• FEV1 of ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to <18 years
• An ACQ score ≥1.5.
• A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:

• Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
• Subjects who have participated in another trial of QAW039.
• A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
• History of malignancy with the exception of local basal cell carcinoma of the skin.
• Pregnant or nursing (lactating) women.
• Serious co-morbidities.
• Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo once daily	Drug: Placebo; Placebo once daily
Experimental: QAW039 150 mg; QAW039 150 mg once daily	Drug: QAW039; QAW039 150 mg once daily; Drug: QAW039; QAW039 450 mg once daily
Experimental: QAW039 450 mg; QAW039 450 mg once daily	Drug: QAW039; QAW039 150 mg once daily; Drug: QAW039; QAW039 450 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation	A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.	Baseline, Week 52
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population	A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours).	Baseline, Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation	Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.	Baseline, Week 52
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population	Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.	Baseline, Week 52
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation	The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.	52 weeks
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation	The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.	Baseline, Week 52
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population	The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life.	Baseline, Week 52
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population	The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled).	Baseline, Week 52

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Brightling CE, Gaga M, Inoue H, Li J, Maspero J, Wenzel S, Maitra S, Lawrence D, Brockhaus F, Lehmann T, Brindicci C, Knorr B, Bleecker ER. Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. Lancet Respir Med. 2021 Jan;9(1):43-56. doi: 10.1016/S2213-2600(20)30412-4. Epub 2020 Sep 24.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2015
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): November 4, 2019

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 21, 2015

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Asthma; allergic asthma; difficulty breathing; QAW039; allergy triggered asthma; reactive asthma; asthma attack
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Growth Substances; Plant Growth Regulators; Indoleacetic Acids
• Other Study ID Numbers: CQAW039A2307; 2015-002553-35 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No