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Hypertonic saline

Phase 1

Respiratory Failure | Small molecule | Respiratory |Community Health Systems, Inc.|Last Updated: Jun 28, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Hypertonic saline · 1 trial · 1 indication

Phase 1 1
NCT01945944Nebulized Hypertonic Saline for Mechanically Ventilated ChildrenRespiratory Failure
COMPLETED18 Analytics
PHASE1COMPLETED
Nebulized Hypertonic Saline for Mechanically Ventilated Children
Respiratory FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Duration of Mechanical Ventilation
typically 4 days - 2 weeks

Secondary Endpoints

Atelectasis
during mechanical ventilation (typically 4 days - 2 weeks)
Wheezing
during mechanical ventilation (typically 4 days - 2 weeks)
ICU Length of Stay
during hospitalization (typically 4 days - 2 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo (0.9% saline), 3mL every 6 hrs for up to 7 days
Hypertonic SalineEXPERIMENTALHypertonic saline (3%), 3mL every 6hrs for up to 7 days

Interventions

NameTypeDescription
Hypertonic saline (3%)DRUG3mL of HTS given via nebulizer every 6hrs
Placebo (0.9% saline)DRUG3mL of normal saline given via nebulizer every 6hrs
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Eligibility Criteria

Age RangeN/A to 18 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * invasive mechanical ventilation of \< 12 hrs duration prior to enrollment * expected duration of mechanical ventilation of \> 48hrs from enrollment * age \< 18yo Exclusion Criteria: * inclusion in another clinical study * cystic fibrosis * status asthmaticus * pulmonary hemo...

Countries:United States
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Frequently asked questions about Hypertonic saline

What is Hypertonic saline used for?

Hypertonic saline is being studied for use in respiratory failure. It is administered as a nebulized solution for mechanically ventilated children. The investigational treatment is currently in Phase 1 clinical development.

Who makes Hypertonic saline?

Hypertonic saline is being developed by Community Health Systems, Inc., a company traded on the New York Stock Exchange under the ticker symbol CYH.

What phase is Hypertonic saline in?

Hypertonic saline is in Phase 1 clinical development. It is an investigational small molecule being studied for respiratory failure and has not been approved by the FDA.

What clinical trials is Hypertonic saline in?

Hypertonic saline has one completed clinical trial, NCT01945944, titled "Nebulized Hypertonic Saline for Mechanically Ventilated Children." The trial enrolled 18 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is Hypertonic saline a small molecule?

Yes, Hypertonic saline is classified as a small molecule therapeutic. It is being investigated as a nebulized treatment for respiratory failure in pediatric patients on mechanical ventilation.