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

This study took place in Europe, Australia and the U.S. It evaluated the safety and effectiveness of hypertonic saline compared to isotonic saline (normal saline) in preschool children with CF.

 Participants in this study took either hypertonic saline (7%)  or normal isotonic saline (0.9%) twice a day via jet nebulizer for 48 weeks.

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 Results

  • What We Learned:

    Inhaled hypertonic (7%)  saline twice a day for 48 weeks in young children with CF resulted in less structural lung disease as measured by CT scan compared with inhaled normal saline.

  • Primary Findings:

    Effectiveness:

    This study was conducted between March 2016 and December 2019. The study enrolled 116 children ages 3-6 years to inhaled hypertonic (7%) saline twice daily or inhaled isotonic (0.9%) saline twice a day for 48 weeks.

     

    The primary outcome was the percentage of total lung volume that had abnormal airways by CT imaging. This was determined using a scoring method called PRAGMA-CF. After 48 weeks, the hypertonic saline treated group had a lower (better) PRAGMA-CF percent disease score compared with the isotonic saline treated group (0.88% vs 1.55% of lung volume). This was a statistically significant difference between the groups.

     

    Safety:

    The number of all adverse events and serious adverse events did not significantly differ between the three groups.

  • Citation:

    Lancet 2022;DOI https://doi.org/10.1016/S2213-2600(21)00546-4 [Epub ahead of print]:2213-2600

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

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

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.

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