AsthmaPhase 3NCT02555683
Efficacy and Safety Study of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
A Phase 3 study testing QAW039 in people with Asthma, run by Novartis Pharmaceuticals at 234 sites in 27 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- QAW039
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 894 participants
- Where
- 234 sitesin 27 countries
- Study dates
- 11 Dec 2015to 4 Nov 2019
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
234 sites in 27 countries.
234 sites in 27 countries
United States55 sites
Novartis Investigative Site
Bangor, Maine, 04401
Novartis Investigative Site
Bellevue, Nebraska, 68123
Novartis Investigative Site
Birmingham, Alabama, 35209
Novartis Investigative Site
Birmingham, Alabama, 35249
Novartis Investigative Site
Boerne, Texas, 78006
Novartis Investigative Site
Brandon, Florida, 33511
Novartis Investigative Site
Canton, Ohio, 44718
Novartis Investigative Site
Charlotte, North Carolina, 28277
Novartis Investigative Site
Cincinnati, Ohio, 45231
Novartis Investigative Site
Corning, New York, 14830
Novartis Investigative Site
Crowley, Louisiana, 70526
Novartis Investigative Site
East Providence, Rhode Island, 02941
Novartis Investigative Site
Fairfax, Virginia, 22030
Novartis Investigative Site
Gainesville, Georgia, 30501
Novartis Investigative Site
Gaithersburg, Maryland, 20878
Novartis Investigative Site
Gastonia, North Carolina, 28054
Novartis Investigative Site
Gilbert, Arizona, 85234
Novartis Investigative Site
Hawaiian Gardens, California, 90716
Novartis Investigative Site
Jefferson Hills, Pennsylvania, 15025
Novartis Investigative Site
Lincoln, Nebraska, 68510
Novartis Investigative Site
Litchfield Park, Arizona, 85340
Novartis Investigative Site
Little Rock, Arkansas, 72209
Novartis Investigative Site
Livonia, Michigan, 48152
Novartis Investigative Site
Marietta, Georgia, 30060
Novartis Investigative Site
Maumee, Ohio, 43537
Novartis Investigative Site
McKinney, Texas, 75069
Novartis Investigative Site
Monroe, North Carolina, 28112
Novartis Investigative Site
New Bern, North Carolina, 28562
Novartis Investigative Site
New Haven, Connecticut, 06520
Novartis Investigative Site
New Smyrna Beach, Florida, 32168
Novartis Investigative Site
New York, New York, 10016
Novartis Investigative Site
Newport Beach, California, 92663
Novartis Investigative Site
Oklahoma City, Oklahoma, 73120
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Orlando, Florida, 32803
Novartis Investigative Site
Orlando, Florida, 32806
Novartis Investigative Site
Ormond Beach, Florida, 32174
Novartis Investigative Site
Peoria, Arizona, 85381
Novartis Investigative Site
Picayune, Mississippi, 39466
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213
Novartis Investigative Site
Plano, Texas, 75093
Novartis Investigative Site
Redondo Beach, California, 90277
Novartis Investigative Site
Riverside, California, 92506
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Antonio, Texas, 78251
Novartis Investigative Site
Sebring, Florida, 33870
Novartis Investigative Site
Torrance, California, 90503
Novartis Investigative Site
Westminster, California, 92683
Novartis Investigative Site
White Marsh, Maryland, 21162
Novartis Investigative Site
Whiteville, North Carolina, 28472
Novartis Investigative Site
Wilmington, North Carolina, 28401
Novartis Investigative Site
Winston-Salem, North Carolina, 27103
Novartis Investigative Site
Winter Park, Florida, 32789
Novartis Investigative Site
Ypsilanti, Michigan, 48197
Novartis Investigative Site
Zachary, Louisiana, 70791
Germany23 sites
Novartis Investigative Site
Berlin, Germany, 10969
Novartis Investigative Site
Berlin, Germany, 12159
Novartis Investigative Site
Berlin, 10717
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Berlin, 12627
Novartis Investigative Site
Berlin, 13187
Novartis Investigative Site
Frankfurt, 60313
Novartis Investigative Site
Frankfurt, 60389
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Halle, 06108
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Heidelberg, Baden-Wurttemberg, 69126
Novartis Investigative Site
Landsberg, 86899
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Leipzig, 04357
Novartis Investigative Site
Magdeburg, 39120
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Marburg, Germany, D-35037
Novartis Investigative Site
Neu-Isenburg, 63263
Novartis Investigative Site
Rosenheim, 83026
Novartis Investigative Site
Rostock, 18057
Novartis Investigative Site
Rüdersdorf, 15562
Novartis Investigative Site
Witten, 58452
China18 sites
Novartis Investigative Site
Beijing, 100050
Novartis Investigative Site
Changchun, Jilin, 130021
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chengdu, 610083
Novartis Investigative Site
Chongqing, 400037
Novartis Investigative Site
Guangzhou, Guangdong, 510120
Novartis Investigative Site
Haikou, Hainan, 570311
Novartis Investigative Site
Hangzhou, Zhejiang, 310014
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Novartis Investigative Site
Nanjing, Jiangsu, 210006
Novartis Investigative Site
Nanjing, Jiangsu, 210009
Novartis Investigative Site
Shanghai, 200433
Novartis Investigative Site
Shenyang, Liaoning, 110000
Novartis Investigative Site
Shenyang, Liaoning, 110003
Novartis Investigative Site
Shijiazhuang, Hebei, 050000
Novartis Investigative Site
Tianjin, 300052
Novartis Investigative Site
Wuhan, Hubei, 430030
Novartis Investigative Site
Xian, Shanxi, 710061
Romania16 sites
Novartis Investigative Site
Arad, 310013
Novartis Investigative Site
Bragadiru, 077025
Novartis Investigative Site
Brasov, Romania, 500283
Novartis Investigative Site
Brasov, 500051
Novartis Investigative Site
Brasov, 500086
Novartis Investigative Site
Brasov, 500366
Novartis Investigative Site
Bucharest, 030317
Novartis Investigative Site
Bucharest, 050554
Novartis Investigative Site
Cluj-Napoca, Romania, 400139
Novartis Investigative Site
Cluj-Napoca, 400371
Novartis Investigative Site
Constanța, ROM, 900412
Novartis Investigative Site
Deva, 330162
Novartis Investigative Site
Oradea, 410176
Novartis Investigative Site
Ploieşti, Prahova, 100024
Novartis Investigative Site
Sangiorgiu de Mures, 547530
Novartis Investigative Site
Timișoara, Timiș County, 300310
United Kingdom16 sites
Novartis Investigative Site
Birmingham, B15 2WB
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
Cambridge, Cambrigdeshire, CB2 0QQ
Novartis Investigative Site
Cardiff, CF14 4XW
Novartis Investigative Site
Chertsey, KT16 0PZ
Novartis Investigative Site
Darlington, Durham, DL3 6HX
Novartis Investigative Site
East Yorkshire, HU16 5JQ
Novartis Investigative Site
Leicester, LE3 9QP
Novartis Investigative Site
London, GBR, EC1M 6BQ
Novartis Investigative Site
Nottingham, NG5 1PB
Novartis Investigative Site
Plymouth, PL6 8DH
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF
Novartis Investigative Site
Tyne and Wear, NE29 8NH
Novartis Investigative Site
Wakefield, WF1 4DG
Novartis Investigative Site
Wishaw, ML2 0DP
Belgium11 sites
Novartis Investigative Site
Aalst, 9300
Novartis Investigative Site
Brussels, Belgium, 1160
Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Brussels, 1020
Novartis Investigative Site
Éghezée, 5310
Novartis Investigative Site
Erpent, 5100
Novartis Investigative Site
Genk, Limburg, 3600
Novartis Investigative Site
Herentals, 2200
Novartis Investigative Site
Kortrijk, 8500
Novartis Investigative Site
Liège, Belgium, 4000
Novartis Investigative Site
Ottignies, 1340
Brazil9 sites
Novartis Investigative Site
Blumenau, Santa Catarina, 89030101
Novartis Investigative Site
Florianópolis, Santa Catarina, 88040-970
Novartis Investigative Site
Porto Alegre, Porto Alegre RS, 90610 000
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-590
Novartis Investigative Site
São Bernardo do Campo, São Paulo, 09715 090
Novartis Investigative Site
São Paulo, São Paulo, 04023-900
Novartis Investigative Site
São Paulo, São Paulo, 05403 000
Novartis Investigative Site
São Paulo, São Paulo, 05437 010
France9 sites
Novartis Investigative Site
Dijon, 21000
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
Novartis Investigative Site
Lyon, 69317
Novartis Investigative Site
Marseille, 13015
Novartis Investigative Site
Montpellier, Herault, 34059
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Paris, 75018
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Strasbourg, 67091
Austria8 sites
Novartis Investigative Site
Amstetten, Austria, 3300
Novartis Investigative Site
Feldkirch, Austria, 6800
Novartis Investigative Site
Graz, Austria, 8036
Novartis Investigative Site
Innsbruck, Tyrol, 6020
Novartis Investigative Site
Thalheim bei Wels, Austria, 4600
Novartis Investigative Site
Vienna, State of Vienna, A-1140
Novartis Investigative Site
Vienna, A 1090
Novartis Investigative Site
Vienna, A-1130
Hungary8 sites
Novartis Investigative Site
Eger, HUN, 3300
Novartis Investigative Site
Győr, HUN, 9024
Novartis Investigative Site
Hajdúnánás, HUN, 4080
Novartis Investigative Site
Komárom, Hungary, 2900
Novartis Investigative Site
Makó, HUN, 6900
Novartis Investigative Site
Pécs, 7635
Novartis Investigative Site
Százhalombatta, HUN, 2440
Novartis Investigative Site
Törökbálint, Pest County, 2045
Lithuania8 sites
Novartis Investigative Site
Kaunas, LTU, LT 50161
Novartis Investigative Site
Kaunas, LT, LT-50128
Novartis Investigative Site
Kaunas, LT-45130
Novartis Investigative Site
Klaipėda, LTU, LT-93220
Novartis Investigative Site
Klaipėda, LT-92231
Novartis Investigative Site
Vilnius, LTU, LT-05263
Novartis Investigative Site
Vilnius, LTU, LT-08406
Novartis Investigative Site
Vilnius, LTU, LT-10207
Poland8 sites
Novartis Investigative Site
Bialystok, 15 276
Novartis Investigative Site
Bialystok, 15-010
Novartis Investigative Site
Biaystok, Poland, 15-430
Novartis Investigative Site
Kielce, POL, 25-371
Novartis Investigative Site
Poznan, 60-214
Novartis Investigative Site
Poznan, 60-693
Novartis Investigative Site
Poznan, 60-823
Novartis Investigative Site
Strzelce Opolskie, 47 100
Guatemala6 sites
Novartis Investigative Site
Ciudad, Gautemala, 01010
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01011
Novartis Investigative Site
Guatemala City, GTM, 01010
Novartis Investigative Site
Guatemala City, GTM, 01011
Novartis Investigative Site
Guatemala City, 01011
Australia5 sites
Novartis Investigative Site
Bedford Park, South Australia, 5041
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Footscray, Victoria, 3011
Novartis Investigative Site
Heidelberg, Victoria, 3084
Novartis Investigative Site
Melbourne, Victoria, 3004
Switzerland5 sites
Novartis Investigative Site
Basel, Switzerland, 4031
Novartis Investigative Site
Liestal, 4410
Novartis Investigative Site
Lugano, 6900
Novartis Investigative Site
Sankt Gallen, 9007
Novartis Investigative Site
Zurich, Switzerland, 8032
Argentina4 sites
Novartis Investigative Site
Buenos Aires, C1012AAR
Novartis Investigative Site
CABA, Buenos Aires, C1425BEN
Novartis Investigative Site
Ciudad Autonoma de Bs As, Ciudad Autonoma de Bs As, C1425FVH
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Finland4 sites
Novartis Investigative Site
Helsinki, 00290
Novartis Investigative Site
HUS, 00029
Novartis Investigative Site
OYS, FIN-90029
Novartis Investigative Site
Tampere, 33520
Estonia3 sites
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tallinn, 13619
Novartis Investigative Site
Tartu, Estonia, 51014
Latvia3 sites
Novartis Investigative Site
Daugavpils, LV-5401
Novartis Investigative Site
Daugavpils, LV-5417
Novartis Investigative Site
Riga, LV 1002
Philippines3 sites
Novartis Investigative Site
Bulacan, Philippines, 3020
Novartis Investigative Site
Manila, Philippines, 1000
Novartis Investigative Site
Quezon City, 1100
Singapore3 sites
Novartis Investigative Site
Singapore, SGP, 117599
Novartis Investigative Site
Singapore, Singapore, 169608
Novartis Investigative Site
Singapore, Singapore, 529889
Vietnam3 sites
Novartis Investigative Site
Hanoi, 100000
Novartis Investigative Site
Ho Chi Minh City, VNM, 700000
Novartis Investigative Site
Ho Chi Minh City, 700000
Ireland2 sites
Novartis Investigative Site
Dublin, 24
Novartis Investigative Site
Dublin, DUBLIN 8
About this study
Official title: 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).
Read the 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.
- Conditions
- Asthma
- Being tested
- QAW039, Placebo
- Keywords
- Asthma, QAW039, allergic asthma, allergy triggered asthma, reactive asthma, asthma attack, difficulty breathing
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QAW039Drug
QAW039 150 mg once daily
QAW039Drug
QAW039 450 mg once daily
PlaceboDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| QAW039 150 mg | Experimental | QAW039 150 mg once daily Receives: Drug: QAW039 |
| QAW039 450 mg | Experimental | QAW039 450 mg once daily Receives: Drug: QAW039 |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study start11 Dec 2015
- Primary completion21 Oct 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 894 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555683
- Sponsor's protocol ID
- CQAW039A2307
- Other IDs
- 2015-002553-35, 2015
- Status last verified
- Apr 2020
- First submitted
- 18 Sep 2015
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 32979986