Saline Hypertonic in Preschoolers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02378467
• Date of registration: 27/02/2015
• Prospective Registration: Yes
• Primary sponsor: University of Washington, the Collaborative Health Studies Coordinating Center
• Public title: Saline Hypertonic in Preschoolers SHIP
• Scientific title: Saline Hypertonic in Preschoolers
• Date of first enrolment: March 1, 2015
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02378467
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada, United States

Contacts

• Name: Felix Ratjen, MD, PhD, FRCPC
• Affiliation: Hospital for Sick Kids, Toronto

• Name: Stephanie Davis, MD
• Affiliation: Indiana University

• Name: Margaret Rosenfeld, MD, MPH
• Affiliation: Seattle Children's Hospital

• Name: Richard A Kronmal, PhD
• Affiliation: University of Washington

Key inclusion & exclusion 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



Age minimum: 3 Years
Age maximum: 5 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: 7% Hypertonic Saline (HS)

Drug: 0.9% Isotonic Saline (IS)

Primary Outcome(s)

Change in Lung Clearance Index (LCI) [Time Frame: 48 weeks]

Secondary Outcome(s)

Pulmonary exacerbation rate [Time Frame: 48 weeks]

Change in Forced Expiratory Volume (FEV) [Time Frame: 48 weeks]

Health-related quality of life [Time Frame: 48 weeks]

Respiratory Pathogen Rate [Time Frame: 48 weeks]

Respiratory Signs [Time Frame: 48 weeks]

Secondary ID(s)

SHIP001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation