MedTrace Logo

Clearing Lungs With ENaC Inhibition in Primary Ciliary Dyskinesia

NCT02871778 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2021-12-16

Study results available
· View outcomes & findings →

Summary

To evaluate the safety and efficacy of treatment with VX-371 with and without ivacaftor, and the effect of VX-371 with and without ivacaftor on quality of life (QOL) in subjects with primary ciliary dyskinesia (PCD).

Conditions

  • Primary Ciliary Dyskinesia

Interventions

DRUG

VX-371

DRUG

Hypertonic Saline

DRUG

Placebo (0.17% saline)

DRUG

VX-371 + HS

DRUG

Ivacaftor

Sponsors & Collaborators

Principal Investigators

  • Karl Donn · Parion Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-11-20
Completion
2018-11-20
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Italy
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02871778 on ClinicalTrials.gov