Saline Hypertonic in Preschoolers

Completed · Not applicable

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 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.

Key facts

Study ID

NCT02378467

Run by

University of Washington, the Collaborative Health Studies Coordinating Center

People needed

150

Starts

2015-03-01

Expected to finish

2018-08-31

Last updated by the study team

2020-01-14

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 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

You may not qualify if…

• 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

Where it is running

• University of Alabama-Birmingham: Pulmonary, Allergy and Critical Care Medicine — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• Children's Hospital of Colorado — Aurora, Colorado, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children-Indiana U Med Center — Indianapolis, Indiana, United States
• University of Iowa, Department of Pediatrics — Iowa City, Iowa, United States
• Johns Hopkins University: Pediatric Pulmonary — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Women & Children's Hospital of Buffalo — Buffalo, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Rainbow Babies Children's Hospital and Case Western Reserve University School of Medicine — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Children's Hospital of Philadelphia, UPenn — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital and Baylor College of Medicine — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• British Columbia Children's Hospital — Vancouver, British Columbia, Canada
• Hospital for Sick Kids — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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