Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02555683
Registration number
NCT02555683
Ethics application status
Date submitted
18/09/2015
Date registered
21/09/2015
Date last updated
18/05/2020
Titles & IDs
Public title
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Query!
Scientific 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.
Query!
Secondary ID [1]
0
0
2015-002553-35
Query!
Secondary ID [2]
0
0
CQAW039A2307
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Asthma
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Asthma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - QAW039
Treatment: Drugs - QAW039
Treatment: Drugs - Placebo
Experimental: QAW039 150 mg - QAW039 150 mg once daily
Experimental: QAW039 450 mg - QAW039 450 mg once daily
Placebo Comparator: Placebo - Placebo once daily
Treatment: Drugs: QAW039
QAW039 150 mg once daily
Treatment: Drugs: QAW039
QAW039 450 mg once daily
Treatment: Drugs: Placebo
Placebo once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline, Week 52
Query!
Primary outcome [2]
0
0
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Baseline, Week 52
Query!
Secondary outcome [1]
0
0
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
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
52 weeks
Query!
Secondary outcome [2]
0
0
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline, Week 52
Query!
Secondary outcome [3]
0
0
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline, Week 52
Query!
Secondary outcome [4]
0
0
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline, Week 52
Query!
Secondary outcome [5]
0
0
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population
Query!
Assessment method [5]
0
0
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).
Query!
Timepoint [5]
0
0
Baseline, Week 52
Query!
Secondary outcome [6]
0
0
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline, Week 52
Query!
Eligibility
Key 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.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/12/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
4/11/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
894
Query!
Recruitment in Australia
Recruitment state(s)
SA,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Bedford Park
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Clayton
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Footscray
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - Heidelberg
Query!
Recruitment hospital [5]
0
0
Novartis Investigative Site - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
5041 - Bedford Park
Query!
Recruitment postcode(s) [2]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [3]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [4]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [5]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maine
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Mississippi
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oklahoma
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Pennsylvania
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Rhode Island
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Buenos Aires
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Tucuman
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Ciudad Autonoma de Bs As
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
Tyrol
Query!
Country [26]
0
0
Austria
Query!
State/province [26]
0
0
Amstetten
Query!
Country [27]
0
0
Austria
Query!
State/province [27]
0
0
Feldkirch
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
Graz
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Thalheim bei Wels
Query!
Country [30]
0
0
Austria
Query!
State/province [30]
0
0
Vienna
Query!
Country [31]
0
0
Austria
Query!
State/province [31]
0
0
Wien
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Limburg
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Aalst
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Brussel
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Bruxelles
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Eghezee
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Erpent
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Herentals
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Kortrijk
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Liege
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Ottignies
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Porto Alegre RS
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
RJ
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
RS
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Santa Catarina
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
SC
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
SP
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Guang Dong Province
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Hainan
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Hebei
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Hubei
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Jiangsu
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Jiangxi
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Jilin
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Liaoning
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Shanxi
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Sichuan
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Zhejiang
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Beijing
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Chengdu
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Chongqing
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Shanghai
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Tianjin
Query!
Country [64]
0
0
Denmark
Query!
State/province [64]
0
0
Copenhagen NV
Query!
Country [65]
0
0
Estonia
Query!
State/province [65]
0
0
Tallinn
Query!
Country [66]
0
0
Estonia
Query!
State/province [66]
0
0
Tartu
Query!
Country [67]
0
0
Finland
Query!
State/province [67]
0
0
Helsinki
Query!
Country [68]
0
0
Finland
Query!
State/province [68]
0
0
HUS
Query!
Country [69]
0
0
Finland
Query!
State/province [69]
0
0
OYS
Query!
Country [70]
0
0
Finland
Query!
State/province [70]
0
0
Tampere
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Herault
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Dijon
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Le Kremlin Bicetre
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Lyon Cedex 04
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Marseille
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Nantes
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Paris
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Reims Cedex
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Strasbourg Cedex
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Baden-Württemberg
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Berlin
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Frankfurt
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Halle
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Hamburg
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Landsberg
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Leipzig
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Magdeburg
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Mainz
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Marburg
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Neu Isenburg
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Rosenheim
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Rostock
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Rudersdorf
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Witten
Query!
Country [95]
0
0
Greece
Query!
State/province [95]
0
0
GR
Query!
Country [96]
0
0
Guatemala
Query!
State/province [96]
0
0
Gautemala
Query!
Country [97]
0
0
Guatemala
Query!
State/province [97]
0
0
GTM
Query!
Country [98]
0
0
Guatemala
Query!
State/province [98]
0
0
Guatemala City
Query!
Country [99]
0
0
Hungary
Query!
State/province [99]
0
0
HUN
Query!
Country [100]
0
0
Hungary
Query!
State/province [100]
0
0
Pest
Query!
Country [101]
0
0
Hungary
Query!
State/province [101]
0
0
Komarom
Query!
Country [102]
0
0
Hungary
Query!
State/province [102]
0
0
Pecs
Query!
Country [103]
0
0
Iceland
Query!
State/province [103]
0
0
Reykjavik
Query!
Country [104]
0
0
Ireland
Query!
State/province [104]
0
0
Dublin
Query!
Country [105]
0
0
Latvia
Query!
State/province [105]
0
0
Daugavpils
Query!
Country [106]
0
0
Latvia
Query!
State/province [106]
0
0
Riga
Query!
Country [107]
0
0
Lithuania
Query!
State/province [107]
0
0
LTU
Query!
Country [108]
0
0
Lithuania
Query!
State/province [108]
0
0
LT
Query!
Country [109]
0
0
Lithuania
Query!
State/province [109]
0
0
Kaunas
Query!
Country [110]
0
0
Lithuania
Query!
State/province [110]
0
0
Klaipeda
Query!
Country [111]
0
0
Philippines
Query!
State/province [111]
0
0
Bulacan
Query!
Country [112]
0
0
Philippines
Query!
State/province [112]
0
0
Manila
Query!
Country [113]
0
0
Philippines
Query!
State/province [113]
0
0
Quezon City
Query!
Country [114]
0
0
Poland
Query!
State/province [114]
0
0
POL
Query!
Country [115]
0
0
Poland
Query!
State/province [115]
0
0
Bialystok
Query!
Country [116]
0
0
Poland
Query!
State/province [116]
0
0
Biaystok
Query!
Country [117]
0
0
Poland
Query!
State/province [117]
0
0
Poznan
Query!
Country [118]
0
0
Poland
Query!
State/province [118]
0
0
Strzelce Opolskie
Query!
Country [119]
0
0
Romania
Query!
State/province [119]
0
0
Prahova
Query!
Country [120]
0
0
Romania
Query!
State/province [120]
0
0
ROM
Query!
Country [121]
0
0
Romania
Query!
State/province [121]
0
0
Timis
Query!
Country [122]
0
0
Romania
Query!
State/province [122]
0
0
Arad
Query!
Country [123]
0
0
Romania
Query!
State/province [123]
0
0
Bragadiru
Query!
Country [124]
0
0
Romania
Query!
State/province [124]
0
0
Brasov
Query!
Country [125]
0
0
Romania
Query!
State/province [125]
0
0
Bucharest
Query!
Country [126]
0
0
Romania
Query!
State/province [126]
0
0
Bucuresti
Query!
Country [127]
0
0
Romania
Query!
State/province [127]
0
0
Cluj Napoca
Query!
Country [128]
0
0
Romania
Query!
State/province [128]
0
0
Deva
Query!
Country [129]
0
0
Romania
Query!
State/province [129]
0
0
Oradea
Query!
Country [130]
0
0
Romania
Query!
State/province [130]
0
0
Sangiorgiu De Mures
Query!
Country [131]
0
0
Singapore
Query!
State/province [131]
0
0
SGP
Query!
Country [132]
0
0
Singapore
Query!
State/province [132]
0
0
Singapore
Query!
Country [133]
0
0
Spain
Query!
State/province [133]
0
0
Barcelona
Query!
Country [134]
0
0
Switzerland
Query!
State/province [134]
0
0
Basel
Query!
Country [135]
0
0
Switzerland
Query!
State/province [135]
0
0
Liestal
Query!
Country [136]
0
0
Switzerland
Query!
State/province [136]
0
0
Lugano
Query!
Country [137]
0
0
Switzerland
Query!
State/province [137]
0
0
St Gallen
Query!
Country [138]
0
0
Switzerland
Query!
State/province [138]
0
0
Zurich
Query!
Country [139]
0
0
United Kingdom
Query!
State/province [139]
0
0
Cambrigdeshire
Query!
Country [140]
0
0
United Kingdom
Query!
State/province [140]
0
0
Durham
Query!
Country [141]
0
0
United Kingdom
Query!
State/province [141]
0
0
GBR
Query!
Country [142]
0
0
United Kingdom
Query!
State/province [142]
0
0
South Yorkshire
Query!
Country [143]
0
0
United Kingdom
Query!
State/province [143]
0
0
West Yorkshire
Query!
Country [144]
0
0
United Kingdom
Query!
State/province [144]
0
0
Birmingham
Query!
Country [145]
0
0
United Kingdom
Query!
State/province [145]
0
0
Cardiff
Query!
Country [146]
0
0
United Kingdom
Query!
State/province [146]
0
0
Chertsey
Query!
Country [147]
0
0
United Kingdom
Query!
State/province [147]
0
0
East Yorkshire
Query!
Country [148]
0
0
United Kingdom
Query!
State/province [148]
0
0
Leicester
Query!
Country [149]
0
0
United Kingdom
Query!
State/province [149]
0
0
Nottingham
Query!
Country [150]
0
0
United Kingdom
Query!
State/province [150]
0
0
Plymouth
Query!
Country [151]
0
0
United Kingdom
Query!
State/province [151]
0
0
Tyne And Wear
Query!
Country [152]
0
0
United Kingdom
Query!
State/province [152]
0
0
Wakefield
Query!
Country [153]
0
0
United Kingdom
Query!
State/province [153]
0
0
Wishaw
Query!
Country [154]
0
0
Vietnam
Query!
State/province [154]
0
0
VNM
Query!
Country [155]
0
0
Vietnam
Query!
State/province [155]
0
0
Hanoi
Query!
Country [156]
0
0
Vietnam
Query!
State/province [156]
0
0
Ho Chi Minh
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02555683
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02555683
Download to PDF