Saline Hypertonic in Preschoolers
SHIP
1 other identifier
interventional
150
2 countries
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedJanuary 14, 2020
December 1, 2019
3.5 years
February 27, 2015
January 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Lung Clearance Index (LCI)
Change in Lung Clearance Index (LCI) from baseline to 48 weeks measured by N2 Multiple Breath Washout (MBW) between subjects randomized to HS and IS.
48 weeks
Secondary Outcomes (5)
Change in Forced Expiratory Volume (FEV)
48 weeks
Pulmonary exacerbation rate
48 weeks
Health-related quality of life
48 weeks
Respiratory Signs
48 weeks
Respiratory Pathogen Rate
48 weeks
Study Arms (2)
Active Treatment Group
EXPERIMENTAL7% Hypertonic Saline administered via inhalation twice daily for 48 weeks
Control Group
ACTIVE COMPARATOR0.9% Isotonic Saline administered via inhalation twice daily for 48 weeks
Interventions
Administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Vios® compressor.
Administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Vios® compressor.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of Alabama-Birmingham: Pulmonary, Allergy and Critical Care Medicine
Birmingham, Alabama, 35233, United States
Stanford University
Palo Alto, California, 94304, United States
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Hospital for Children-Indiana U Med Center
Indianapolis, Indiana, 46202, United States
University of Iowa, Department of Pediatrics
Iowa City, Iowa, 52242, United States
Johns Hopkins University: Pediatric Pulmonary
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Women & Children's Hospital of Buffalo
Buffalo, New York, 14222, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7217, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies Children's Hospital and Case Western Reserve University School of Medicine
Cleveland, Ohio, 44212, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia, UPenn
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Texas Children's Hospital and Baylor College of Medicine
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Hospital for Sick Kids
Toronto, Ontario, M5G 1X8, Canada
Related Publications (3)
Rosenfeld M, Ratjen F, Brumback L, Daniel S, Rowbotham R, McNamara S, Johnson R, Kronmal R, Davis SD; ISIS Study Group. Inhaled hypertonic saline in infants and children younger than 6 years with cystic fibrosis: the ISIS randomized controlled trial. JAMA. 2012 Jun 6;307(21):2269-77. doi: 10.1001/jama.2012.5214.
PMID: 22610452BACKGROUNDAmin R, Subbarao P, Jabar A, Balkovec S, Jensen R, Kerrigan S, Gustafsson P, Ratjen F. Hypertonic saline improves the LCI in paediatric patients with CF with normal lung function. Thorax. 2010 May;65(5):379-83. doi: 10.1136/thx.2009.125831.
PMID: 20435858BACKGROUNDRatjen F, Davis SD, Stanojevic S, Kronmal RA, Hinckley Stukovsky KD, Jorgensen N, Rosenfeld M; SHIP Study Group. Inhaled hypertonic saline in preschool children with cystic fibrosis (SHIP): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2019 Sep;7(9):802-809. doi: 10.1016/S2213-2600(19)30187-0. Epub 2019 Jun 6.
PMID: 31178421RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Davis, MD
Indiana University
- PRINCIPAL INVESTIGATOR
Richard A Kronmal, PhD
University of Washington
- PRINCIPAL INVESTIGATOR
Felix Ratjen, MD, PhD, FRCPC
Hospital for Sick Kids, Toronto
- PRINCIPAL INVESTIGATOR
Margaret Rosenfeld, MD, MPH
Seattle Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 4, 2015
Study Start
March 1, 2015
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
January 14, 2020
Record last verified: 2019-12