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 and QAW039 450 mg compared to 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 (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 and 450 mg) or placebo was added to 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 optional safety study (CQAW039A2315) directly after the Week 52 study visit

• Study Type: Interventional
• Enrollment (Actual): 877
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125ABE
    • Novartis Investigative Site
  • Buenos Aires, Argentina, C1012AAR
    • Novartis Investigative Site
  • Mendoza, Argentina, 5500
    • Novartis Investigative Site
  • Mendoza, Argentina, M5500CBA
    • Novartis Investigative Site
  • Santa Fe, Argentina, S3000FIL
    • Novartis Investigative Site
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, 1888
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1122AAK
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1426ABP
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1425BEN
      • Novartis Investigative Site
    • Lanus, Buenos Aires, Argentina, B8000XAV
      • Novartis Investigative Site
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Novartis Investigative Site
    • Ranelagh, Partido De Berazate, Buenos Aires, Argentina, 1884
      • Novartis Investigative Site
  • Ciudad Autonoma De Bs As
    • Buenos Aires, Ciudad Autonoma De Bs As, Argentina, C1425FVH
      • Novartis Investigative Site
  • La Pampa
    • Santa Rosa, La Pampa, Argentina, 6300
      • Novartis Investigative Site
  • Rosario
    • Santa Fe, Rosario, Argentina, S2000DBS
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000AII
      • Novartis Investigative Site
    • Rosario, Santa Fe, Argentina, S2000BRH
      • Novartis Investigative Site
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Novartis Investigative Site
• Canada
  • Quebec, Canada, G1V 4W2
    • Novartis Investigative Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Novartis Investigative Site
    • Vancouver BC, British Columbia, Canada, V6Z 1Y6
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H3G 1L5
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H4J 1C5
      • Novartis Investigative Site
• Czechia
  • Brno, Czechia, 615 00
    • Novartis Investigative Site
  • Karlovy Vary, Czechia, 360 17
    • Novartis Investigative Site
  • Mlada Boleslav, Czechia, 293 50
    • Novartis Investigative Site
  • Plzen-Bory, Czechia, 305 99
    • Novartis Investigative Site
  • CZE
    • Teplice, CZE, Czechia, 415 01
      • Novartis Investigative Site
  • Czech Republic
    • Jindrichuv Hradec, Czech Republic, Czechia, 377 01
      • Novartis Investigative Site
    • Teplice, Czech Republic, Czechia, 415 01
      • Novartis Investigative Site
• Greece
  • Athens, Greece, 12462
    • Novartis Investigative Site
  • Athens, Greece, 175 62
    • Novartis Investigative Site
  • GR
    • Athens, GR, Greece, 115 27
      • Novartis Investigative Site
    • Thessaloniki, GR, Greece, 570 10
      • Novartis Investigative Site
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 060
      • Novartis Investigative Site
    • Ahmedabad, Gujarat, India, 380 008
      • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Novartis Investigative Site
    • Bangalore, Karnataka, India, 560004
      • Novartis Investigative Site
  • Maharashtra
    • Nagpur, Maharashtra, India, 440015
      • Novartis Investigative Site
    • Pune, Maharashtra, India, 411014
      • Novartis Investigative Site
  • Rajasthan
    • Jaipur, Rajasthan, India, 302039
      • Novartis Investigative Site
    • Jaipur, Rajasthan, India, 302001
      • Novartis Investigative Site
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India, 641 045
      • Novartis Investigative Site
    • Madurai, Tamil Nadu, India, 625 020
      • Novartis Investigative Site
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Novartis Investigative Site
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226006
      • Novartis Investigative Site
• Israel
  • Haifa, Israel, 3525408
    • Novartis Investigative Site
  • Jerusalem, Israel, 91120
    • Novartis Investigative Site
  • Jerusalem, Israel, 91031
    • Novartis Investigative Site
  • Petach Tikva, Israel, 49100
    • Novartis Investigative Site
  • Rehovot, Israel, 76100
    • Novartis Investigative Site
• Italy
  • Milano, Italy, 20142
    • Novartis Investigative Site
  • Milano, Italy, 20100
    • Novartis Investigative Site
  • Reggio Emilia, Italy, 42123
    • Novartis Investigative Site
  • Salerno, Italy, 84100
    • Novartis Investigative Site
  • AN
    • Ancona, AN, Italy, 60126
      • Novartis Investigative Site
  • BA
    • Acquaviva delle Fonti, BA, Italy, 70021
      • Novartis Investigative Site
    • Bari, BA, Italy, 70124
      • Novartis Investigative Site
  • BS
    • Brescia, BS, Italy, 25123
      • Novartis Investigative Site
  • CT
    • Catania, CT, Italy, 95125
      • Novartis Investigative Site
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • Novartis Investigative Site
  • FE
    • Cona, FE, Italy, 44100
      • Novartis Investigative Site
  • FG
    • Foggia, FG, Italy, 71100
      • Novartis Investigative Site
  • ME
    • Messina, ME, Italy, 98125
      • Novartis Investigative Site
  • PD
    • Padova, PD, Italy, 35128
      • Novartis Investigative Site
  • PI
    • Pisa, PI, Italy, 56124
      • Novartis Investigative Site
  • RM
    • Roma, RM, Italy, 00168
      • Novartis Investigative Site
  • SI
    • Siena, SI, Italy, 53100
      • Novartis Investigative Site
  • Sicilia
    • Cagliari, Sicilia, Italy, 09042
      • Novartis Investigative Site
  • TO
    • Torino, TO, Italy, 10128
      • Novartis Investigative Site
  • VR
    • Legnago, VR, Italy, 37045
      • Novartis Investigative Site
    • Verona, VR, Italy, 37126
      • Novartis Investigative Site
• Japan
  • Fukuoka
    • Chikushino-city, Fukuoka, Japan, 818-8502
      • Novartis Investigative Site
    • Fukuoka city, Fukuoka, Japan, 811-1394
      • Novartis Investigative Site
    • Kasuga-city, Fukuoka, Japan, 816-0813
      • Novartis Investigative Site
  • Hiroshima
    • Hiroshima-city, Hiroshima, Japan, 734-8530
      • Novartis Investigative Site
  • Ibaraki
    • Naka-gun, Ibaraki, Japan, 319-1113
      • Novartis Investigative Site
  • Kagawa
    • Sakaide-city, Kagawa, Japan, 762-8550
      • Novartis Investigative Site
    • Takamatsu-city, Kagawa, Japan, 761-8073
      • Novartis Investigative Site
  • Kagoshima
    • Kagoshima city, Kagoshima, Japan, 890 8520
      • Novartis Investigative Site
  • Kanagawa
    • Yokohama city, Kanagawa, Japan, 232 0024
      • Novartis Investigative Site
  • Osaka
    • Kishiwada-city, Osaka, Japan, 596-8501
      • Novartis Investigative Site
  • Shizuoka
    • Hamamatsu-city, Shizuoka, Japan, 431-3192
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo ku, Tokyo, Japan, 113-8431
      • Novartis Investigative Site
    • Chuo ku, Tokyo, Japan, 104-0031
      • Novartis Investigative Site
    • Setagaya-Ku, Tokyo, Japan, 157-0072
      • Novartis Investigative Site
    • Shinagawa-ku, Tokyo, Japan, 142-8666
      • Novartis Investigative Site
    • Toshima ku, Tokyo, Japan, 170 0003
      • Novartis Investigative Site
• Lebanon
  • Ashrafieh, Lebanon, 166830
    • Novartis Investigative Site
  • Beirut, Lebanon, 166378
    • Novartis Investigative Site
  • LBN
    • El Chouf, LBN, Lebanon, 1503201002
      • Novartis Investigative Site
• Malaysia
  • Batu Caves, Malaysia, 68100
    • Novartis Investigative Site
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 15586
      • Novartis Investigative Site
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Novartis Investigative Site
  • Perak
    • Taiping, Perak, Malaysia, 34000
      • Novartis Investigative Site
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Novartis Investigative Site
    • Guadalajara Jalisco, Jalisco, Mexico, 44220
      • Novartis Investigative Site
    • Zapopan, Jalisco, Mexico, 45200
      • Novartis Investigative Site
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Novartis Investigative Site
  • Arnhem, Netherlands, 6815 AD
    • Novartis Investigative Site
  • Leeuwarden, Netherlands, 8934 AD
    • Novartis Investigative Site
  • Leiden, Netherlands, 2333 ZA
    • Novartis Investigative Site
• Russian Federation
  • Ekaterinburg, Russian Federation, 620035
    • Novartis Investigative Site
  • Izhevsk, Russian Federation, 426061
    • Novartis Investigative Site
  • Moscow, Russian Federation, 115478
    • Novartis Investigative Site
  • Moscow, Russian Federation, 109544
    • Novartis Investigative Site
  • Moscow, Russian Federation, 105077
    • Novartis Investigative Site
  • N.Novgorod, Russian Federation, 603126
    • Novartis Investigative Site
  • Novosibirsk, Russian Federation, 630091
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197022
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 194354
    • Novartis Investigative Site
  • Sestroretsk, Russian Federation, 197706
    • Novartis Investigative Site
  • Stavropol, Russian Federation, 355000
    • Novartis Investigative Site
• Serbia
  • Belgrade, Serbia, 11000
    • Novartis Investigative Site
  • Belgrade, Serbia, 11070
    • Novartis Investigative Site
  • Kragujevac, Serbia, 34000
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, 826 06
    • Novartis Investigative Site
  • Komarno, Slovakia, 945 01
    • Novartis Investigative Site
  • Kosice, Slovakia, 040 01
    • Novartis Investigative Site
  • Levice, Slovakia, 934 01
    • Novartis Investigative Site
  • Spisska Nova Ves, Slovakia, 052 01
    • Novartis Investigative Site
  • Vysne Hagy, Slovakia, 5984
    • Novartis Investigative Site
  • Bratislava
    • Dubravka, Bratislava, Slovakia, 84102
      • Novartis Investigative Site
  • Slovak Republic
    • Bardejov, Slovak Republic, Slovakia, 085 01
      • Novartis Investigative Site
    • Bojnice, Slovak Republic, Slovakia, 972 01
      • Novartis Investigative Site
    • Liptovsky Hradok, Slovak Republic, Slovakia, 033 01
      • Novartis Investigative Site
• South Africa
  • Mowbray, South Africa, 7700
    • Novartis Investigative Site
  • Panorama, South Africa, 7500
    • Novartis Investigative Site
  • Cape Town
    • Tygerberg, Cape Town, South Africa, 7505
      • Novartis Investigative Site
• Spain
  • Girona, Spain, 17005
    • Novartis Investigative Site
  • Guadalajara, Spain, 19002
    • Novartis Investigative Site
  • Las Palmas de Gran Canaria, Spain, 35010
    • Novartis Investigative Site
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Madrid, Spain, 28046
    • Novartis Investigative Site
  • Santiago de Compostela, Spain, 15706
    • Novartis Investigative Site
  • Zaragoza, Spain, 50009
    • Novartis Investigative Site
  • Andalucia
    • Malaga, Andalucia, Spain, 29009
      • Novartis Investigative Site
  • Cadiz
    • Jerez, Cadiz, Spain, 11407
      • Novartis Investigative Site
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
  • Cataluña
    • Sabadell, Cataluña, Spain, 08208
      • Novartis Investigative Site
  • Galicia
    • Lugo, Galicia, Spain, 27003
      • Novartis Investigative Site
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07120
      • Novartis Investigative Site
• Taiwan
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taichung, Taiwan, 40705
    • Novartis Investigative Site
  • Taiwan ROC
    • Taichung, Taiwan ROC, Taiwan, 40201
      • Novartis Investigative Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72209
      • Novartis Investigative Site
  • California
    • San Jose, California, United States, 95117
      • Novartis Investigative Site
    • Stockton, California, United States, 95207
      • Novartis Investigative Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Novartis Investigative Site
    • Denver, Colorado, United States, 80206
      • Novartis Investigative Site
  • Florida
    • Winter Park, Florida, United States, 32789
      • Novartis Investigative Site
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Novartis Investigative Site
  • New York
    • Bronx, New York, United States, 10459
      • Novartis Investigative Site
    • New York, New York, United States, 10016
      • Novartis Investigative Site
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Novartis Investigative Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19115
      • Novartis Investigative Site
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Novartis Investigative Site
    • Houston, Texas, United States, 77005
      • Novartis Investigative Site
    • Plano, Texas, United States, 75093
      • Novartis Investigative Site
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Novartis Investigative Site
    • Richmond, Virginia, United States, 23220
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent.
• Male and female patients aged ≥12 years.
• A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
• Evidence of airway reversibility or airway hyper- reactivity.
• FEV1 ≤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 >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• 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.	52 weeks
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).	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses. 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 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. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 to 6. Higher scores indicates worsening of condition. 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 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 Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population	AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.	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. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 to 6. Higher scores indicates worsening of condition.	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

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 3, 2015
• Primary Completion (Actual): July 4, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 28, 2015
• First Posted (Estimate): September 29, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Asthma; QAW039
• 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: CQAW039A2314; 2015-003172-67 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

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