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Mucociliary Clearance Completed with Results

Infant Study of Inhaled Saline (ISIS) (ISIS-002)

The purpose of this study was to determine whether 7% hypertonic saline (HS) was an effective and safe therapy in infants and young children with CF.

This study randomized participants to either receive 7% hypertonic saline or 0.9% isotonic saline twice daily for 48 weeks.A growing body of evidence supports the importance of intervention in Cystic Fibrosis (CF) lung disease during infancy, in order to potentially delay or prevent irreversible lung disease. Hypertonic Saline (HS) is a chronic maintenance therapy that is appropriate to investigate in infants because it addresses defective mucociliary clearance, an early step in the cascade of events leading to CF lung disease that is expected to be abnormal prior to the onset of airway infection and inflammation.

Eligibility

  • Age:

    4 Months 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:

    Study results show that there was no reduction in the rate of pulmonary exacerbations in the treatment group compared to the control group.

  • Primary Findings:

    Effectiveness:

    This phase 3 multi-center study was conducted between April 2009 and October 2011. A total of 321 children participated with 158 randomized to 7% hypertonic saline and 163 randomized to the control (0.9% isotonic saline). The majority of participants completed the study (143 of 158 in the hypertonic saline group, and 149 of 163 in the control group). The primary outcome was the rate of pulmonary exacerbations during the 48-week treatment period. The use of inhaled hypertonic saline compared with isotonic saline did not reduce the rate of pulmonary exacerbations over the course of 48 weeks of treatment.

     

    There was no significant difference in secondary endpoints including height, weight, respiratory rate, oxygen saturation, cough, respiratory symptom scores, or antibiotic use. Infant pulmonary function testing performed in a subgroup of participants (n=73) did not demonstrate significant differences between the treatments except for the mean change in forced expiratory volume in 0.5 seconds, which was 38 mL greater in the 7% hypertonic saline group.

    Safety:

    Adverse event profiles were similar for both 7% hypertonic saline and control treatments.

  • Citation:

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:

    48 weeks

  • Number of Study Visits:

    7

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Rosenfeld, Margaret

  • Study Drugs:

    Hypertonic Saline

Eligibility

  • Age:

    4 Months 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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