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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

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Vertex Pharmaceuticals

Status and phase

Completed
Phase 4

Conditions

Cystic Fibrosis

Treatments

Drug: Placebo
Drug: LUM/IVA

Study type

Interventional

Funder types

Industry

Identifiers

NCT02875366
2016-000066-34 (EudraCT Number)
VX15-809-112

Details and patient eligibility

About

This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation. This study is designed to evaluate the effect of LUM/IVA on exercise tolerance in subjects with CF, homozygous for the F508del-CFTR mutation.

Enrollment

70 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Homozygous for the F508del-CFTR mutation
  • 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

  • History of any comorbidity that might confound the results of the study, interfere with the use of cardiopulmonary exercise tests (CPETs) as an assessment, or pose an additional risk in administering study drug to the subject
  • 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

70 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo matched to LUM/IVA fixed-dose combination tablet orally every 12 hours (q12h) for 24 weeks.
Treatment:
Drug: Placebo
LUM/IVA
Experimental group
Description:
LUM 400 milligram (mg)/IVA 250 mg fixed-dose combination tablet orally q12h for 24 weeks.
Treatment:
Drug: LUM/IVA

Trial documents
2

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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