Saline Hypertonic in Preschoolers

• Status: Completed
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks improves the lung clearance index by multiple breath nitrogen washout in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 5) with cystic fibrosis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington, the Collaborative Health Studies Coordinating Center
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics

Criteria

Inclusion Criteria:

• Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:

• A documented sweat chloride ≥ 60 milliequivalents of solute per litre (mEq/L) by quantitative pilocarpine iontophoresis (QPIT)

• A documented genotype with two disease-causing mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene

• Informed consent by parent or legal guardian

• Age ≥ 36 months and ≤72 months at Screening visit

• Ability to comply with medication use, study visits and study procedures as judged by the site investigator

• Ability to perform technically acceptable MBW measurements at the screening and enrollment visits

Exclusion Criteria:

• Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding Screening or Enrollment visit

• Acute wheezing at Screening or Enrollment visit

• Oxygen saturation < 95% (<90% in centers located above 4000 feet elevation) at Screening or Enrollment visit

• Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator

• Investigational drug use within 30 days prior to Screening or Enrollment visit

• Treatment with inhaled hypertonic saline at any concentration within 30 days prior to Screening or Enrollment visit

• Chronic lung disease not related to CF

• Inability to tolerate first dose of study treatment at the Enrollment visit