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

NCT02555683 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CQAW039A23072015-002553-35
• Study Type: interventional
• Target: 894
• Locations: 25 countries
• Sites: 224

Brief Summary

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).

Conditions

Asthma

Keywords

Asthma; QAW039; allergic asthma; allergy triggered asthma; reactive asthma; asthma attack; difficulty breathing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  52 weeks

• Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation

  Baseline, Week 52

• Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation

  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

  Baseline, Week 52

• Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population

  Baseline, Week 52

Study Arms (3)

QAW039 150 mg

EXPERIMENTAL

QAW039 150 mg once daily

Drug: QAW039

QAW039 450 mg

EXPERIMENTAL

QAW039 450 mg once daily

Drug: QAW039

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

QAW039 DRUG

QAW039 150 mg once daily

QAW039 150 mg

Placebo DRUG

Placebo once daily

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (233)

Novartis Investigative Site

Birmingham, Alabama, 35209, United States

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Birmingham, Alabama, 35249, United States

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Gilbert, Arizona, 85234, United States

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Litchfield Park, Arizona, 85340, United States

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Peoria, Arizona, 85381, United States

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Little Rock, Arkansas, 72209, United States

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Hawaiian Gardens, California, 90716, United States

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Newport Beach, California, 92663, United States

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Redondo Beach, California, 90277, United States

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Riverside, California, 92506, United States

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Torrance, California, 90503, United States

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Westminster, California, 92683, United States

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New Haven, Connecticut, 06520, United States

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Brandon, Florida, 33511, United States

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New Smyrna Beach, Florida, 32168, United States

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Orlando, Florida, 32803, United States

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Orlando, Florida, 32806, United States

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Ormond Beach, Florida, 32174, United States

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Novartis Investigative Site

Sebring, Florida, 33870, United States

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Winter Park, Florida, 32789, United States

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Gainesville, Georgia, 30501, United States

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Marietta, Georgia, 30060, United States

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Crowley, Louisiana, 70526, United States

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Zachary, Louisiana, 70791, United States

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Bangor, Maine, 04401, United States

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Gaithersburg, Maryland, 20878, United States

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White Marsh, Maryland, 21162, United States

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Livonia, Michigan, 48152, United States

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Ypsilanti, Michigan, 48197, United States

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Picayune, Mississippi, 39466, United States

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Bellevue, Nebraska, 68123, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68131, United States

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Corning, New York, 14830, United States

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New York, New York, 10016, United States

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Charlotte, North Carolina, 28277, United States

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Gastonia, North Carolina, 28054, United States

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Monroe, North Carolina, 28112, United States

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New Bern, North Carolina, 28562, United States

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Whiteville, North Carolina, 28472, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45231, United States

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Maumee, Ohio, 43537, United States

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Oklahoma City, Oklahoma, 73120, United States

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Jefferson Hills, Pennsylvania, 15025, United States

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Pittsburgh, Pennsylvania, 15213, United States

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East Providence, Rhode Island, 02941, United States

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Boerne, Texas, 78006, United States

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McKinney, Texas, 75069, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78251, United States

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Fairfax, Virginia, 22030, United States

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CABA, Buenos Aires, C1425BEN, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Buenos Aires, C1012AAR, Argentina

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Ciudad Autonoma de Bs As, C1425FVH, Argentina

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Bedford Park, South Australia, 5041, Australia

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Clayton, Victoria, 3168, Australia

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Footscray, Victoria, 3011, Australia

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Heidelberg, Victoria, 3084, Australia

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Melbourne, Victoria, 3004, Australia

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Innsbruck, Tyrol, 6020, Austria

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Amstetten, 3300, Austria

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Feldkirch, 6800, Austria

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Graz, 8036, Austria

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Thalheim bei Wels, 4600, Austria

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Vienna, A 1090, Austria

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Vienna, A-1130, Austria

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Vienna, A-1140, Austria

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Genk, Limburg, 3600, Belgium

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Aalst, 9300, Belgium

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Brussels, 1000, Belgium

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Brussels, 1020, Belgium

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Brussels, 1160, Belgium

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Erpent, 5100, Belgium

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Éghezée, 5310, Belgium

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Herentals, 2200, Belgium

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Kortrijk, 8500, Belgium

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Liège, 4000, Belgium

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Ottignies, 1340, Belgium

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Porto Alegre, Porto Alegre RS, 90610 000, Brazil

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Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Blumenau, Santa Catarina, 89030101, Brazil

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Florianópolis, Santa Catarina, 88040-970, Brazil

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São Bernardo do Campo, São Paulo, 09715 090, Brazil

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São Paulo, São Paulo, 04023-900, Brazil

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São Paulo, São Paulo, 05403 000, Brazil

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São Paulo, São Paulo, 05437 010, Brazil

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Guangzhou, Guangdong, 510120, China

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Haikou, Hainan, 570311, China

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Shijiazhuang, Hebei, 050000, China

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Wuhan, Hubei, 430030, China

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Nanjing, Jiangsu, 210006, China

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Nanjing, Jiangsu, 210009, China

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Nanchang, Jiangxi, 330006, China

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Changchun, Jilin, 130021, China

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Shenyang, Liaoning, 110000, China

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Shenyang, Liaoning, 110003, China

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Xian, Shanxi, 710061, China

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Chengdu, Sichuan, 610041, China

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Hangzhou, Zhejiang, 310014, China

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Beijing, 100050, China

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Chengdu, 610083, China

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Chongqing, 400037, China

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Shanghai, 200433, China

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Tianjin, 300052, China

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Copenhagen NV, 2400, Denmark

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Tallinn, 13419, Estonia

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Tallinn, 13619, Estonia

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Tartu, 51014, Estonia

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Helsinki, 00290, Finland

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HUS, 00029, Finland

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OYS, FIN-90029, Finland

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Tampere, 33520, Finland

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Montpellier, Herault, 34059, France

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Dijon, 21000, France

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Le Kremlin-Bicêtre, 94275, France

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Lyon, 69317, France

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Marseille, 13015, France

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Nantes, 44093, France

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Paris, 75018, France

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Reims, 51092, France

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Strasbourg, 67091, France

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Heidelberg, Baden-Wurttemberg, 69126, Germany

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Berlin, 10717, Germany

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Berlin, 10969, Germany

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Berlin, 12159, Germany

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Berlin, 12203, Germany

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Berlin, 12627, Germany

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Berlin, 13187, Germany

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Frankfurt, 60313, Germany

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Frankfurt, 60389, Germany

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Frankfurt, 60596, Germany

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Halle, 06108, Germany

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Hamburg, 20354, Germany

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Landsberg, 86899, Germany

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Leipzig, 04103, Germany

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Leipzig, 04357, Germany

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Magdeburg, 39120, Germany

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Mainz, 55131, Germany

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Marburg, D-35037, Germany

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Neu-Isenburg, 63263, Germany

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Rosenheim, 83026, Germany

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Rostock, 18057, Germany

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Rüdersdorf, 15562, Germany

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Witten, 58452, Germany

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Thessaloniki, GR, 570 10, Greece

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Ciudad, Gautemala, 01010, Guatemala

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Guatemala City, GTM, 01010, Guatemala

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Guatemala City, GTM, 01011, Guatemala

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Guatemala City, 01010, Guatemala

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Guatemala City, 01011, Guatemala

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Eger, HUN, 3300, Hungary

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Győr, HUN, 9024, Hungary

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Hajdúnánás, HUN, 4080, Hungary

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Makó, HUN, 6900, Hungary

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Százhalombatta, HUN, 2440, Hungary

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Törökbálint, Pest County, 2045, Hungary

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Komárom, 2900, Hungary

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Pécs, 7635, Hungary

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Reykjavik, 109, Iceland

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Dublin, 24, Ireland

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Dublin, DUBLIN 8, Ireland

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Daugavpils, LV-5401, Latvia

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Daugavpils, LV-5417, Latvia

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Riga, LV 1002, Latvia

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Kaunas, LTU, LT 50161, Lithuania

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Klaipėda, LTU, LT-93220, Lithuania

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Vilnius, LTU, LT-05263, Lithuania

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Vilnius, LTU, LT-08406, Lithuania

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Vilnius, LTU, LT-10207, Lithuania

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Kaunas, LT, LT-50128, Lithuania

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Kaunas, LT-45130, Lithuania

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Klaipėda, LT-92231, Lithuania

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Bulacan, 3020, Philippines

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Manila, 1000, Philippines

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Quezon City, 1100, Philippines

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Biaystok, Poland, 15-430, Poland

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Kielce, POL, 25-371, Poland

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Bialystok, 15 276, Poland

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Bialystok, 15-010, Poland

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Poznan, 60-214, Poland

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Poznan, 60-693, Poland

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Poznan, 60-823, Poland

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Strzelce Opolskie, 47 100, Poland

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Ploieşti, Prahova, 100024, Romania

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Constanța, ROM, 900412, Romania

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Timișoara, Timiș County, 300310, Romania

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Arad, 310013, Romania

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Bragadiru, 077025, Romania

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Brasov, 500051, Romania

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Brasov, 500086, Romania

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Brasov, 500283, Romania

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Brasov, 500366, Romania

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Bucharest, 030317, Romania

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Bucharest, 050554, Romania

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Cluj-Napoca, 400139, Romania

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Cluj-Napoca, 400371, Romania

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Deva, 330162, Romania

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Oradea, 410176, Romania

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Sangiorgiu de Mures, 547530, Romania

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Singapore, SGP, 117599, Singapore

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Singapore, 169608, Singapore

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Singapore, 529889, Singapore

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Barcelona, 08006, Spain

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Basel, 4031, Switzerland

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Liestal, 4410, Switzerland

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Lugano, 6900, Switzerland

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Sankt Gallen, 9007, Switzerland

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Zurich, 8032, Switzerland

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Cambridge, Cambrigdeshire, CB2 0QQ, United Kingdom

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Darlington, Durham, DL3 6HX, United Kingdom

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London, GBR, EC1M 6BQ, United Kingdom

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Sheffield, South Yorkshire, S10 2JF, United Kingdom

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Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Birmingham, B15 2WB, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Cardiff, CF14 4XW, United Kingdom

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Chertsey, KT16 0PZ, United Kingdom

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East Yorkshire, HU16 5JQ, United Kingdom

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Leicester, LE3 9QP, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Tyne and Wear, NE29 8NH, United Kingdom

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Wakefield, WF1 4DG, United Kingdom

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Wishaw, ML2 0DP, United Kingdom

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Ho Chi Minh City, VNM, 700000, Vietnam

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Hanoi, 100000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Related Publications (1)

• 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.

  PMID: 32979986 DERIVED

MeSH Terms

Conditions

Asthma; Dyspnea

Interventions

fevipiprant

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 21, 2015
• Study Start: December 11, 2015
• Primary Completion: October 21, 2019
• Study Completion: November 4, 2019
• Last Updated: May 18, 2020
• Results First Posted: May 18, 2020

Record last verified: 2020-04

Locations

GU (5); PH (3); AU (5); BR (9); AR (4); FR (9); IE (2); BE (11); LA (3); RO (16); HU (8); US (55); IC (1); PL (8); DK (1); CH (5); ES (3); DE (23); LI (8); SG (3); GR (1); GB (16); CN (18); FI (4); VN (3)