A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation
NCT ID: NCT02875366
Last Updated: 2019-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2016-09-30
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Placebo
Placebo matched to LUM/IVA fixed-dose combination tablet orally every 12 hours (q12h) for 24 weeks.
Placebo
LUM/IVA
LUM 400 milligram (mg)/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.
LUM/IVA
Interventions
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LUM/IVA
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative pilocarpine iontophoresis
* Stable CF disease as judged by the investigator
* Forced expiratory volume in 1 second (FEV1) at least 40% and not greater than 90% of predicted
Exclusion Criteria
* Any previous exposure to LUM or IVA
* History of cardiac arrhythmia, ischemic heart disease, congestive heart failure, or other clinically significant cardiac condition, or medical condition requiring chronic use of a beta blocker, non-dihydropyridine calcium channel blocker, or other cardiac medication known to affect exercise tolerance
* History of solid organ or hematological transplantation
* For subjects under 18 years of age at Screening, except those who have had bilateral lens removal, selected findings on a screening ophthalmologic examination will be exclusionary
* Using or expected to require any concomitant medication that is prohibited in this study
* History of alcohol or drug abuse, as deemed by the investigator, in the past year, including but not limited to cannabis, cocaine, and opiates
* Participation in an investigational drug study within 30 days before the Screening Visit
* Pregnant or nursing females; males with a female partner who is pregnant or nursing
* Colonization with organisms associated with a more rapid decline in pulmonary status
12 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Adelaide, , Australia
Camperdown, , Australia
Clayton, , Australia
Nedlands, , Australia
New Lambton Heights, , Australia
Randwick, , Australia
South Brisbane, , Australia
Subiaco, , Australia
Westmead, , Australia
Edinburgh, , United Kingdom
Countries
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References
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Wilson J, You X, Ellis M, Urquhart DS, Jha L, Duncan M, Tian S, Harris RA, Kotsimbos T, Keating D. VO2max as an exercise tolerance endpoint in people with cystic fibrosis: Lessons from a lumacaftor/ivacaftor trial. J Cyst Fibros. 2021 May;20(3):499-505. doi: 10.1016/j.jcf.2020.12.006. Epub 2020 Dec 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000066-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VX15-809-112
Identifier Type: -
Identifier Source: org_study_id
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