Cystic Fibrosis Therapy Using Saline Hypertonic: The SHIP-CT Study – Phase II/III

Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography

Protocol Description

This purpose of this multi-center international study is to see if inhaling or breathing a solution with a high amount of salt may help thin the mucus in the lungs of preschool aged children with cystic fibrosis. This hypertonic saline has been proven to be safe and effective for people ages 6 and older who have cystic fibrosis. This study of younger children will utilize computed tomography, a type of imaging also called a CT scan, enabling researchers to measure changes to the lung structure. Additionally, participants will use a new type of breathing test, called multiple breath washout, to measure effectiveness of the hypertonic saline. 

Study Level: Phase II/III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to participants of both genders, ages 3 through 5, who have cystic fibrosis.
Males and females: Ages 3 through 5


In this study, participants will be randomly assigned to take either hypertonic saline or normal saline, called isotonic saline, given via a nebulizer twice a day for about a year. Additionally, participants will be seen by the research team for physical exams and imaging.
Visits: 6
Duration: About 12 months, plus additional telephone follow up from the research coordinator to review health status.

Status: Open to Enrollment

Source(s) of Support

Cystic Fibrosis Foundation Therapeutics

Primary Investigator

Daniel Weiner, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Nurse Coordinator
Adrienne DeRicco, RN, BSN, CCRC