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SHIP CT: Study of hypertonic saline in preschoolers (SHIP002)

This study is taking place in Europe, Australia and the U.S. It will look at the safety and effectiveness of hypertonic saline compared to isotonic saline (normal saline) in children with CF.

 This study will look the safety and effectiveness of hypertonic saline (7%) twice a day via jet nebulizer in preschool children and is almost identifical to the SHIP study. This study is placebo-controlled, meaning that some study participants will receive hypertonic saline, and others will receive the control treatment (normal saline). Researchers will test the effectiveness of hypertonic saline by measuring lung function and will also perform CT scans before and after 48 weeks of hypertonic saline. 

Eligibility

  • Age:

    3 Years to 5 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    54 weeks

  • Number of Study Visits:

    6

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Rosenfeld, Margaret

  • Study Drugs:

    Hypertonic Saline

Study Sites

  • Closed to Enrollment

    Colorado

    Children's Hospital Colorado, Aurora, CO 80045

  • Closed to Enrollment

    Indiana

    Riley Hospital for Children, Indianapolis, IN 46202

  • Closed to Enrollment

    Missouri

    St. Louis Children's Hospital, St. Louis, MO 63110

  • Closed to Enrollment

    North Carolina

    University of North Carolina at Chapel Hill, Chapel Hill, NC 27599

  • Closed to Enrollment

    Oregon

    Oregon Health Sciences University, Portland, OR 97239

  • Closed to Enrollment

    Pennsylvania

    Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224

  • Closed to Enrollment

    Washington

    Seattle Children's Hospital, Seattle, WA 98105

Eligibility

  • Age:

    3 Years to 5 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Clinical Studies 101

  • Questions to Ask When Considering a Specific Trial

    Clinical trials that test potential drugs and therapies in people with cystic fibrosis are a major part of CF research. They take place at Cystic Fibrosis Foundation-accredited care centers all over the United States and enroll people with CF of all ages.

  • Patient Safety Is a Priority

    Nothing is more important than patient safety in developing new treatments for cystic fibrosis. The U.S. government requires that all clinical trials are supervised for safety, and the Cystic Fibrosis Foundation adds additional measures to protect study volunteers.

  • How Do Clinical Trials Work

    Each clinical trial has a study sponsor and a protocol. Potential drugs must move through four well-defined phases of testing in patients.

     

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