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Mucociliary Clearance Completed with Results
SHIP: Study of hypertonic saline in preschoolers (SHIP001)
The SHIP study evaluated the safety and effectiveness of hypertonic saline (7%) in pre-school children with CF.
Participants in the study were randomly assigned to receive either 4mL of 7% hypertonic (concentrated) saline or the control treatment, 0.9% regular saline. Participants inhaled the assigned treatment via jet nebulizer twice a day for 48 weeks.
Eligibility
-
Age:
3 Years to 5 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
Less than 99%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
The study found that hypertonic saline improved lung function, as measured by Lung Clearance Index (LCI), compared with the regular saline group. However, no differences between the groups were noted in the length of time to a participant’s next pulmonary exacerbation, or on the CFQ-R, a health questionnaire. Hypertonic saline was shown to be well-tolerated.
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Primary Findings:
Effectiveness:
This study was conducted between April 2015 and October 2018. 76 participants were assigned to the hypertonic saline group and 74 to the regular saline group.
The primary efficacy outcome was change in lung function. Researchers measured the change in Lung Clearance Index (LCI) from the beginning of the study to week 48. During the trial, lung function improved in the hypertonic saline group (LCI decreased by -0.38) and worsened in the regular saline group (LCI increased by 0.35). The difference between the groups was –0.63 units (p=0·010).
No differences between the groups were noted for the length of time to a participant’s next pulmonary exacerbation. Additionally, there were no differences in scores on the respiratory domain of the CFQ-R, a health questionnaire completed by the participant’s caregiver.
Safety:
Hypertonic saline was well-tolerated. Similar adverse events occurred at the same rate in both groups.
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Citation:
Lancet ;DOI 10.1016/S2213-2600(19)30187-0 [Epub ahead of print];S2213-2600(19):30187
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:
Eligibility
-
Age:
3 Years to 5 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
Less than 99%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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