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Trial details
Trial details
LUSTER-Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Current status:
Approved
|
Date registered:
16/06/2020
Trial version(s)
History: 01/01/2020
History: 01/01/2020
History: 01/01/2020
History: 01/01/2020
Current: 01/01/2020
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2020011378
Protocol number
CQAW039A2314
MOH registration number
37148/2017
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
Trial previously submitted before LBCTR initiation
Date of registration in national regulatory agency
02/10/2017
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
LUSTER-Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Acronym
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.
Acronym
Brief summary of the study: English
This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2015) in each of the groups (patients with severe asthma and high eosinophil counts and all patients with severe asthma)
Brief summary of the study: Arabic
دراسة من 52 أسبوعًا متعددة المراكز وجُزافيّة ومزدوجة التعمية ومراقبة الدواء الوهمي لتقييم فعاليّة وسلامة دواء QAW039 عندما يُضاف إلى علاج الربو الحالي لدى المرضى المصابين بالربو الحاد غير المتحكّم به
Health conditions/problem studied: Specify
Respiratory - Asthma
Interventions: Specify
•Drug: QAW039 QAW039 Dose 1 once daily •Drug: QAW039 QAW039 Dose 2 once daily •Drug: Placebo Placebo once daily
Key inclusion and exclusion criteria: Inclusion criteria
•Written informed consent. •Male and female patients aged more than or equal 12 years. •A diagnosis of severe asthma, uncontrolled on GINA 4 over 5 asthma medication. •Evidence of airway reversibility or airway hyper- reactivity. •FEV1 less than or equal 80 percent of the predicted normal value for patients aged more than or equal 18 years; FEV1 of less than or equal 90 percent for patients aged 12 to less than 18 years •An ACQ score more than or equal 1.5 •A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
12
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: 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) more than or equal 450 msec (male) or more than or equal 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 more than 20 mg of simvastatin, more than 40 mg of atorvastatin, more than 40 mg of pravastatin, or more than 2 mg of pitavastatin.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
Fevipiprant
Type of IMP
Cell therapy
Pharmaceutical class
CRTh2 antagonist
Therapeutic indication
GINA steps 3, 4 and 5 patients with uncontrolled asthma
Therapeutic benefit
Reduction in the rate of moderate-to-severe asthma exacerbations
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
9
Actual enrollment target size
9
Date of first enrollment: Type
Actual
Date of first enrollment: Date
28/02/2018
Date of study closure: Type
Actual
Date of study closure: Date
19/11/2019
Recruitment status
Complete
Date of completion
31/05/2018
IPD sharing statement plan
No
IPD sharing statement 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.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT02563067?term=QAW039&cond=A+52-week%2C+multicenter%2C+randomized%2C+double-blind%2C+placebocontrolled&cntry=LB&draw=1&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinicaltrials.gov
NCT02563067
Sources of Monetary or Material Support
Name
Novartis Pharmaceuticals
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Zouheir
Alameh
El Chouf
Lebanon
70-669618
alamehclinic@gmail.com
Ain Wazein Medical Village
Scientific
Hind
Khairallah
Sin Elfil
Lebanon
961 1512002#271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Carla
Irani
Beirut
Lebanon
03-495496
iranica@yahoo.com
Hotel Dieu De France
Public
Georges
Juvelikian
Beirut
Lebanon
03-497 574
gsjuvelekian@stgeorgehospital.org
Saint George Hospital University Medical Center
Public
Carole
Youakim
Beirut
Lebanon
961-925 722
caroleyou@hotmail.com
Mount Lebanon Hopsital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Ain Wazein Medical Village
Zouheir Alameh
Pulmonary Medicine
Approved
Hotel Dieu de France
Carla Irani
Allergy Clinical Immunology
Approved
Saint George Hospital University Medical Center
Georges Juvelikian
Pulmonary Medicine
Approved
Mount Lebanon Hopsital
Carole Youakim
Pulmonary Medicine
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
21/07/2017
Nancy Alam
nancy.alam@usj.edu.lb
961 (0) 1 421000 ext 2335
Saint George Hospital University Medical Center
05/09/2017
Michel Daher
mndaher@stgeorgehospital.org
01/581714
Ain w Zein Medical Village
21/07/2017
Khaled Abdel Baki
Khaled.abdelbaki@awmedicalvillage.org
(0) 5 509 001 ext 2000
Mount Lebanon Hospital
25/04/2017
Marie Merheb
Marie.merheb@mlh.com.lb
(0) 5 957 000 exr 1200
Countries of Recruitment
Name
Lebanon
Argentina
Canada
Greece
India
Italy
Japan
Mexico
Spain
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Asthma
Asthma, unspecified (J45.9)
Asthma/ respiratory
Interventions
Intervention
Description
Keyword
Informed Consent, Physical Exam, Vital Signs, ePROs questionnaire, Study drug/placebo administration , lab tests, spirometry, Lab tests, ECG
Informed Consent, Physical Exam, Vital Signs, ePROs questionnaire, Study drug/placebo administration , lab tests, spirometry, Lab tests, ECG
Informed Consent, Physical Exam, Vital Signs, ePROs questionnaire, Study drug/placebo administration , lab tests, spirometry, Lab tests, ECG
Primary Outcomes
Name
Time points
Measure
Moderate-to-severe asthma exacerbations
52 weeks
52 weeks
Key Secondary Outcomes
Name
Time points
Measure
•Asthma Quality of Life Questionnaire
52 weeks
52 weeks
•Pre-dose Forced Expiratory Volume in 1 second (FEV1)
52 weeks
52 weeks
Trial Results
Summary results in Lebanon
Please reference this link about study results
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
https://www.novartis.com/news/media-releases/novartis-provides-update-luster-phase-iii-studies-patients-uncontrolled-gina-45-asthma
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Study closure date updated and IMP reconcilation reports attached
06/06/2020
Download as PDF
Save a PDF copy of the summary of the trial