• Mucociliary ClearanceCompleted with Results

  SHIP CT: Study of hypertonic saline in preschoolers , protocol number 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.

  • Age:

    3 Years to 5 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

  • Number of Visits:

    6

  • Length of Participation:

    54 weeks

• Mucociliary ClearanceCompleted with Results

  Phase 2 study of VX-371 in people with CF who are currently taking lumacaftor/ivacaftor , protocol number Vertex VX-371-101

  This study evaluated the safety and effectiveness of the inhaled drug VX-371 (formerly P-1037) in combination with hypertonic saline in participants who have two copies of the F508del CFTR mutation and are taking lumacaftor/ivacaftor (Orkambi®).

  • Age:

    12 Years and Older

  • Mutation(s):

    Two Copies F508del

  • FEV1% Predicted:

    40 to 90%

  • Number of Visits:

    12

  • Length of Participation:

    98 days

• Mucociliary ClearanceCompleted with Results

  SHIP: Study of hypertonic saline in preschoolers , protocol number SHIP001

  The SHIP study evaluated the safety and effectiveness of hypertonic saline (7%) in pre-school children with CF. 

  • Age:

    3 Years to 5 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    Less than 99%

  • Number of Visits:

    6

  • Length of Participation:

    54 weeks

• Mucociliary ClearanceCompleted with Results

  Clearing Lungs With ENAC Inhibition in Cystic Fibrosis (CLEAN-CF) , protocol number Parion PS-G201

  This study evaluated the drug P-1037 and its effectiveness in combination with the drug hypertonic saline in people with CF. There was no restriction based on CFTR mutation.

  • Age:

    12 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 90%

  • Number of Visits:

    4

  • Length of Participation:

    5 weeks

• Mucociliary ClearanceCompleted with Results

  Infant Study of Inhaled Saline (ISIS) , protocol number 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.

  • Age:

    4 Months to 5 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

  • Number of Visits:

    7

  • Length of Participation:

    48 weeks

• OtherCompleted with Results

  SIMPLIFY: Study to evaluate stopping inhaled hypertonic saline or dornase alfa in people with CF who are taking Trikafta® , protocol number SIMPLIFY-IP-19

  This study evaluated the effects and safety of stopping inhaled hypertonic saline or dornase alfa (Pulmozyme®) in teens and adults with CF who are also taking the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor (Trikafta®). 

  • Age:

    12 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    60% or greater

  • Number of Visits:

    4

  • Length of Participation:

    10 weeks

Studies in this tool are multi-center studies facilitated by the Cystic Fibrosis Therapeutics Development Network. For a complete list of cystic fibrosis related studies, visit www.clinicaltrials.gov.