Saline Hypertonic in Preschoolers + CT

Completed · Phase 2/Phase 3

Conditions studied: Cystic Fibrosis

In brief

The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.

Key facts

Study ID

NCT02950883

Run by

University of Washington, the Collaborative Health Studies Coordinating Center

People needed

116

Starts

2015-03-24

Expected to finish

2021-06-25

Last updated by the study team

2024-03-12

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CF as evidenced by one or more clinical features consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:
• A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
• A documented genotype with two disease-causing mutations in the 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 cooperate with chest CT at the enrollment visit as determined by the lung function technician

You may not qualify if…

• Chest CT within 8 months prior to the Screening visit
• 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
• Other major organ dysfunction, excluding pancreatic dysfunction
• 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 HS at any concentration within 30 days prior to screening or enrollment visit
• Initiation (i.e. new prescription) of any inhaled hydrating agent such as mannitol or mucolytic agents such as dornase alpha within 30 days prior to the screening or enrollment visit
• Chronic lung disease not related to CF
• Inability to tolerate first dose of study treatment at the enrollment visit

Where it is running

• Children's Hospital of Colorado — Aurora, Colorado, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Royal Women's and Children Hospital — Adelaide, Australia
• Lady Cilento Children's Hospital — Brisbane, Australia
• Royal Children's Hospital — Melbourne, Australia
• John Hunter Children's Hospital — Newcastle, Australia
• Children's Hospital at Westmead — Sydney, Australia
• Sydney Children's Hospital at Randwick — Sydney, Australia
• Perth Children's Hospital — West Perth, Australia
• Universitair Ziekenhuis Children's Hospital — Brussels, Belgium
• UZ Leuven - Gasthuisberg Ziekenhuis — Leuven, Belgium
• British Columbia Children's Hospital — Vancouver, British Columbia, Canada
• Hospital for Sick Kids — Toronto, Ontario, Canada
• Copenhagen University Hospital Rigshospitalet — Copenhagen, Denmark
• Hospice Civils de Lyon — Lyon, France
• Hospital Robert Debre — Paris, France
• Bambini Gesu Children's Hospital — Roma, Italy
• Ospedale Civile Maggiore — Verona, Italy
• Sophia Children's Hospital at Erasmus Medical Centre — Rotterdam, Netherlands
• Hospital Universitari Vall d'Hebron — Barcelona, Spain

Full record on ClinicalTrials.gov

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