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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03052517
Registration number
NCT03052517
Ethics application status
Date submitted
23/01/2017
Date registered
14/02/2017
Titles & IDs
Public title
Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
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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.
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Secondary ID [1]
0
0
2016-001560-11
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Secondary ID [2]
0
0
CQAW039A2315
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
0
0
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Condition category
Condition code
Respiratory
0
0
0
0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - QAW039 150 mg
Treatment: Drugs - QAW039 450 mg
Treatment: Drugs - Placebo
Experimental: QAW039 150mg - QAW039 Dose 1 once daily
Experimental: QAW039 450 mg - QAW039 Dose 2 once daily
Placebo comparator: Placebo - Placebo once daily
Treatment: Drugs: QAW039 150 mg
One tablet of QAW039 150 mg once daily
Treatment: Drugs: QAW039 450 mg
One tablet of QAW039 450 mg once daily
Treatment: Drugs: Placebo
One tablet of Placebo once daily
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model
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Assessment method [1]
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Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported.
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Timepoint [1]
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52 weeks
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Primary outcome [2]
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0
Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model
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Assessment method [2]
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Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs
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Timepoint [2]
0
0
156 weeks
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Primary outcome [3]
0
0
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model
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Assessment method [3]
0
0
Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported.
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Timepoint [3]
0
0
52 weeks
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Primary outcome [4]
0
0
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model
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Assessment method [4]
0
0
Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs.
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Timepoint [4]
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156 weeks
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Primary outcome [5]
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Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model
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Assessment method [5]
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Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported.
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Timepoint [5]
0
0
52 weeks
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Primary outcome [6]
0
0
Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model
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Assessment method [6]
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Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation
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Timepoint [6]
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156 weeks
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Secondary outcome [1]
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Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model
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Assessment method [1]
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The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)
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Timepoint [1]
0
0
52 weeks
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Secondary outcome [2]
0
0
Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model
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Assessment method [2]
0
0
The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE)
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Timepoint [2]
0
0
156 weeks
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Secondary outcome [3]
0
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Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52
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Assessment method [3]
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The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.
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Timepoint [3]
0
0
52 weeks
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Secondary outcome [4]
0
0
Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156
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Assessment method [4]
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The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs.
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Timepoint [4]
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156 weeks
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Secondary outcome [5]
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Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52
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Assessment method [5]
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Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE).
Rate of exacerbations per person year = total number of exacerbations / total number of treatment years
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Timepoint [5]
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0
52 weeks
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Secondary outcome [6]
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Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156
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Assessment method [6]
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Number of treatment emergent severe asthma exacerbation episodes requiring hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per person year of follow-up. Treatment emergent severe asthma exacerbation episodes are defined as episodes occurring on or after the day of the first intake of study drug and until the day of last intake of study drug +7 days (30 days in the case of a serious AE).
Rate of exacerbations per person year = total number of exacerbations / total number of treatment years
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Timepoint [6]
0
0
156 weeks
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Eligibility
Key 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.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/03/2020
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Sample size
Target
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Accrual to date
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Final
2538
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
0
0
Novartis Investigative Site - Clayton
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Recruitment hospital [2]
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Novartis Investigative Site - Footscray
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Recruitment hospital [3]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3011 - Footscray
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
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0
0
United States of America
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State/province [1]
0
0
Alabama
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0
0
United States of America
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0
0
California
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0
0
United States of America
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0
Colorado
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0
0
United States of America
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Florida
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0
0
United States of America
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Georgia
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United States of America
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Kansas
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United States of America
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Montana
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Nebraska
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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Texas
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La Pampa
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Rosario
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Argentina
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Belgium
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Erpent
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Belgium
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Belgium
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Liege
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GO
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Brazil
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Porto Alegre RS
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Brazil
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RJ
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Brazil
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RS
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Santa Catarina
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SP
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Bulgaria
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Pleven
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Ruse
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Stara Zagora
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Ontario
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Canada
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Vancouver
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China
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Guang Dong Province
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China
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Hebei
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China
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Jiangsu
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China
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Jilin
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China
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Liaoning
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China
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Shanxi
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China
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China
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Beijing
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China
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Chongqing
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Shanghai
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Tolima
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Bogota
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Colombia
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Bucaramanga
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Brno
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Tallinn
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Tartu
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Finland
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Helsinki
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France
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Herault
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France
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Dijon
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France
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Le Kremlin Bicetre
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France
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Lyon Cedex 04
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France
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France
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Nantes
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France
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Paris cedex 18
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France
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Germany
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Sachsen
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Germany
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Aschaffenburg
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Landsberg
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Germany
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Leipzig
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Germany
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Witten
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Greece
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GR
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Greece
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Athens
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Guatemala
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Guatemala
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GTM
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Guatemala
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Guatemala City
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Hungary
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HUN
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Hungary
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Budapest
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Godollo
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Hungary
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Leicester
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Funding & Sponsors
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Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was 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. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (=12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.
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Trial website
https://clinicaltrials.gov/study/NCT03052517
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Trial related presentations / publications
Maspero J, Agache IO, Kamei T, Yoshida M, Boone B, Felser JM, Kawakami F, Knorr B, Lawrence D, Lehmann T, Wang W, Pedinoff AJ. Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial. Respir Res. 2021 Dec 11;22(1):311. doi: 10.1186/s12931-021-01904-8.
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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
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When will data be available (start and end dates)?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/17/NCT03052517/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/17/NCT03052517/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03052517