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NCT02378467 · ClinicalTrials.gov registry record · NA
Saline Hypertonic in Preschoolers
A NA study of Cystic Fibrosis, sponsored by University of Washington, the Collaborative Health Studies Coordinating Center.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT02378467: Completed NA study of Cystic Fibrosis, sponsored by University of Washington, the Collaborative Health Studies Coordinating Center.
NCT02378467 is a NA study of Cystic Fibrosis that has completed, run by University of Washington, the Collaborative Health Studies Coordinating Center. The registered enrollment target is 150 participants, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02378467, a NA study of Cystic Fibrosis, has completed, sponsored by University of Washington, the Collaborative Health Studies Coordinating Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 7% Hypertonic Saline (HS)
- DRUG 0.9% Isotonic Saline (IS)
Study Locations (20)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Rainbow Babies Children's Hospital and Case Western Reserve University School of Medicine - Cleveland
- Nationwide Children's Hospital - Columbus
Missouri
- Children's Mercy Hospital - Kansas City
- Washington University School of Medicine - St Louis
Pennsylvania
- Children's Hospital of Philadelphia, UPenn - Philadelphia
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Alabama
- University of Alabama-Birmingham: Pulmonary, Allergy and Critical Care Medicine - Birmingham
California
- Stanford University - Palo Alto
Colorado
- Children's Hospital of Colorado - Aurora
Florida
- Nemours Children's Hospital - Orlando
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2015-03-01 |
| Est. Completion | 2018-08-31 |
| Phase | NA |
Sponsor
University of Washington, the Collaborative Health Studies Coordinating Center5 total trials
What the finished NCT02378467 record still lists
NCT02378467 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which 7% Hypertonic Saline (HS) is the first listed.
NCT02378467 names 20 study sites across 16 states, led by Ohio, Missouri, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02378467 about?
NCT02378467 is a clinical study titled "Saline Hypertonic in Preschoolers". 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.
What is the current status of trial NCT02378467?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2015-03-01. Estimated completion is 2018-08-31.
What conditions does trial NCT02378467 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT02378467?
The interventions under investigation include: 7% Hypertonic Saline (HS) (DRUG), 0.9% Isotonic Saline (IS) (DRUG).
Who is sponsoring clinical trial NCT02378467?
This trial is sponsored by University of Washington, the Collaborative Health Studies Coordinating Center, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02378467 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02378467's enrollment target sits among peer trials
150 43rd of 169 higher than 125 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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