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Trial details
Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
Current status:
Approved
|
Date registered:
23/01/2020
Trial version(s)
History: 01/11/2019
History: 01/11/2019
History: 01/11/2019
History: 01/11/2019
Current: 01/11/2019
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Main Information
Primary registry identifying number
LBCTR2019121309
Protocol number
CQAW039A2315
MOH registration number
23137/2018
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
This was earlier submitted as paper before implementation of LBCTR , this study still have patients ongoing until 2022
Date of registration in national regulatory agency
31/05/2018
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharma Services Inc.
Public title
Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
Acronym
Scientific title
A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
Acronym
Brief summary of the study: English
This study is a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study is to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma.
Brief summary of the study: Arabic
دراسة متوازية المجموعة ومتعددة المراكز ومراقبة الدواء الوهمي وعشوائيّة التوزيع ذات فترتيّ علاج لتقييم سلامة دواء QAW039 عندما يُضاف إلى علاج الربو الحالي لدى مرضى المراحل 3 و4 و5 حسب المبادرة العالميّة للربو المصابين بالربو غير المتحكّم به
Health conditions/problem studied: Specify
Respiratory - Asthma
Interventions: Specify
•Drug: QAW039 Dose 1 QAW039 Dose 1 once daily •Drug: QAW039 Dose 2 QAW039 Dose 2 once daily •Drug: Placebo Placebo once daily
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion Criteria: Patients completing a prior Phase 3 study of QAW039: •Informed consent and assent (if applicable). •Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039. •Patient is able to safely continue into the study as judged by the investigator. Patients who have not previously participated in a study of QAW039: •Written informed consent. •A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication. •Evidence of airway reversibility or airway hyper- reactivity. •FEV1 of ≤85% of the predicted normal value. •An ACQ score ≥1.5 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
Exclusion Criteria: Patients completing a prior phase 3 study of QAW039: •Pregnant or nursing (lactating) women. •Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug •Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in. •Inability to comply with all study requirements. •Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in. Patients who have not previously participated in a study of QAW039: •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 (i.e.-the patient was randomized in another study). •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> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.
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
QAW has a function on lung function (FEV1) in patients with moderate-to-severe asthma, and an improvement in quality-of-life scores and asthma control questionnaire scores in severe patients uncontrolled at baseline. In one study, QAW039 also demonstrated a reduction in sputum eosinophils in patients with severe asthma.The overall purpose of this study is to provide long-term safety data for fevipiprant (QAW039) (150 mg once daily and 450 mg once daily), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in adult and adolescent (≥12 years) patients with moderate-tosevere asthma.
Biospecimen retention
None retained
Biospecimen description
A central laboratory will be used to analyze and report blood chemistry/hematology and urinalysis/ urine chemistry
Target sample size
20
Actual enrollment target size
20
Date of first enrollment: Type
Actual
Date of first enrollment: Date
15/11/2018
Date of study closure: Type
Actual
Date of study closure: Date
01/11/2022
Recruitment status
Complete
Date of completion
28/11/2019
IPD sharing statement plan
Yes
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. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03052517?cond=Asthma&cntry=LB&rank=3
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinical trials.gov
NCT03052517
Sources of Monetary or Material Support
Name
Novartis Pharma services Inc
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Carla
Irani
Beirut
Lebanon
iranica@yahoo.com
961-3-495496
Hotel Dieu De France
Scientific
Hind
Khairallah
Sinelfil
Lebanon
+961 1512002#271
Hind.Khairallah@fattal.com.lb
KFF Healthcare - Khalil
Public
Zouheir
Alameh
Ainwazein
Lebanon
961-70-669618
alamehclinic@gmail.com
Ainwazein Medical Village
Public
Georges
Juvelikian
Beirut
Lebanon
01 441 000
juveleg@hotmail.com
Saint George Hospital University Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu de France
Carla Irani
Allergy & Clinical Immunology
Approved
Ain Wazein Medical Village
Zouheir Alameh
Pulmonary Medicine
Approved
Saint George Hospital University Medical Center
Georges Juvelikian
Pulmonary Medicine
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
21/07/2018
Nancy Alam
nancy.alam@usj.edu.lb
961 (0) 1 421000 ext 2335
Saint George Hospital University Medical Center
27/07/2018
Michel Daher
mndaher@stgeorgehospital.org
961 (0)1 441 733
Ain w Zein Medical Village
20/07/2018
Khaled Abdel Baki
Khaled.abdelbaki@awmedicalvillage.org
961 (0) 5 509 001 ext 2000
Countries of Recruitment
Name
Lebanon
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
China
Colombia
Czech Republic
Greece
Hungary
India
Japan
Kuwait
Tunisia
United Kingdom
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Asthma
Asthma, unspecified (J45.9)
Respiratory , Asthma
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
treatment-emergent adverse events AEs
52 weeks
52 weeks
•treatment emergent serious adverse events
52 weeks
52 weeks
•treatment emergent AEs leading to study treatment discontinuation
52 weeks
52 weeks
Key Secondary Outcomes
Name
Time points
Measure
•Rate of patients with at least 1 treatment emergent AE by primary system organ class
52 weeks
52 weeks
•Rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation
52 weeks
52 weeks
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Attached IRB letters related to magnesium central lab issue
22/01/2020
Download as PDF
Save a PDF copy of the summary of the trial