Hypertonic saline

also known as HTS · ClNa 3% (sodium chloride 3%) · Hyper-Sal, inhaled saline · hyperosmolar saline · Hypertonic Saline Solution · Plabottle

Developed for: cystic fibrosis · acute bronchiolitis · bronchiolitis · traumatic brain injury · brain edema · bronchiectasis · intracranial hypertension · pulmonary non-tuberculous mycobacterial infection
+28 more
· respiratory failure · acute lung injury · acute respiratory distress syndrome · cerebral malaria · chronic obstructive pulmonary disease · chronic pain syndrome · chronic rhinosinusitis · corneal edema · COVID-19 · female stress incontinence · hidradenitis suppurativa · infectious disease with sepsis · intracranial hypotension · intracranial vasospasm · nephrotic syndrome · preeclampsia · primary ciliary dyskinesia · pulmonary edema · radiculopathy · rotator cuff syndrome · stroke disorder · subarachnoid hemorrhage · traumatic encephalopathy · urethral syndrome · acute liver failure · asthma · lung disorder · rectal prolapse
Investigated by: Cystic Fibrosis Foundation · National Heart, Lung, and Blood Institute (NHLBI) · Assiut University · Aalborg University · CF Therapeutics Development Network Coordinating Center · National Institute of Neurological Disorders and Stroke (NINDS)
+80 more
· Northwestern University · Parion Sciences · The Hospital for Sick Children · Thomas Jefferson University · University of Colorado, Denver · University of Washington · University of Washington, the Collaborative Health Studies Coordinating Center · Aga Khan University · Ann & Robert H Lurie Children's Hospital of Chicago · Assistance Publique - Hôpitaux de Paris · Belfast Health and Social Care Trust · Beth Israel Deaconess Medical Center · Canadian Cystic Fibrosis Foundation · Canadian Department of National Defence · Canadian Institutes of Health Research (CIHR) · Central Directorate of the Army Health Service · Chiesi España · Children's Hospital of Philadelphia · Children's National Research Institute · Cystic Fibrosis Trust · Defence Research and Development Canada · Denver Health and Hospital Authority · EPC Education s.r.o. · East Slovak Institute for Cardiovascular Diseases · German Center for Lung Research · Hamad Medical Corporation · Haukeland University Hospital · Heart and Stroke Foundation of Canada · Heidelberg University · Hospital General Naval de Alta Especialidad - Escuela Medico Naval · Hospital General de Ciudad Real · Hospital General de Niños Pedro de Elizalde · Hospital San Carlos, Madrid · Inonu University · Johns Hopkins University · Joseph Zabner · Kamuzu University of Health Sciences · Le Bonheur Children's Hospital · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Massachusetts General Hospital · Mayo Clinic · Medical University of Bialystok · Michigan State University · Muhammad Aamir Latif · NTM Info & Research, Inc. · National Health and Medical Research Council, Australia · National Institute of Allergy and Infectious Diseases (NIAID) · National Science and Technology Council, Taiwan · Nationwide Children's Hospital · Nazmy Edward Seif · New York University · Ohio State University · OhioHealth · Oregon Health and Science University · Otsuka America Pharmaceutical · Philips Respironics · Queen's University, Belfast · Rady Children's Hospital, San Diego · Rothman Institute Orthopaedics · Royal Prince Alfred Hospital, Sydney, Australia · Sheikh Khalifa Medical City · Slovak Academy of Sciences · Taipei Veterans General Hospital, Taiwan · Tanta University · The Danish Rheumatism Association · The Institute of Circulatory and Respiratory Health (ICRH) · Tim Corcoran · Turgut Ozal University · U.S. Army Medical Research and Development Command · University Health Network, Toronto · University Hospital, Grenoble · University Hospitals Cleveland Medical Center · University of California, San Diego · University of Castilla-La Mancha · all 86 on the full record

Trials 60

200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 17 trials
Phase 1	NCT02947126	Jan 2017 → Feb 2020	cystic fibrosis	Tim Corcoran	Completed	No outcome recorded
Phase 1	NCT02141191	Jun 2014 → Oct 2015	cystic fibrosis	University of Pittsburgh	Completed	No outcome recorded
Phase 1	NCT01713595	Oct 2013 → May 2015	pulmonary edema	Mayo Clinic	Withdrawn	No outcome recorded
Phase 1	NCT01667666	May 2012 → Nov 2018	acute lung injury, adult acute respiratory distress syndrome	Denver Health and Hospital Authority	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT00753987	Mar → Jul 2006	cystic fibrosis	The Hospital for Sick Children	Completed	No outcome recorded
Phase 1	NCT00181077	Jun 2003 → Apr 2006	preeclampsia	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT00359697	—	intracranial hypertension	Thomas Jefferson University	Unknown	No outcome recorded
Phase 1/26 trials
Phase 1/2	NCT06370975	Aug 2024 → Aug 2025	—	Assiut University	Unknown	No outcome recorded
Phase 1/2	NCT02432157	Jan 2015 → Jan 2017	intracranial vasospasm, subarachnoid hemorrhage	Thomas Jefferson University	Unknown	No outcome recorded
Phase 1/2	NCT01945944	Oct 2013 → Apr 2014	respiratory failure	University Hospitals Cleveland Medical Center	Completed	No outcome recorded
Phase 1/2	NCT01605357	Jul 2012 → Jul 2013	brain edema, traumatic brain injury	Massachusetts General Hospital	Withdrawn	No outcome recorded
Phase 1/2	NCT01355796	May 2011 → Feb 2015	cystic fibrosis	Joseph Zabner	Completed	No outcome recorded
Phase 1/2	NCT01612494	Mar 2010 → Apr 2012	—	University of California, San Diego	Completed	No outcome recorded
Phase 24 trials · 1 met primary
Phase 2	NCT03276494	Apr 2017 → Apr 2018	brain edema, intracranial hypotension, stroke disorder	Ohio State University	Completed	No outcome recorded
Phase 2	NCT02871778	Aug 2016 → Nov 2018	primary ciliary dyskinesia	Parion Sciences	Completed	Met primary
Phase 2	NCT02805595	Aug 2016 → Nov 2022	hidradenitis suppurativa	Beth Israel Deaconess Medical Center	Completed	No outcome recorded
Phase 2	NCT01619657	Jun 2012 → Nov 2016	cystic fibrosis	Heidelberg University	Completed	No outcome recorded
Phase 2/32 trials · 1 met primary
Phase 2/3	NCT02950883	Mar 2015 → Dec 2020	cystic fibrosis	University of Washington, the Collaborative Health Studies Coordinating Center	Completed	Met primary
Phase 2/3	NCT00151905	Nov 2003 → Sep 2006	bronchiolitis	Sheikh Khalifa Medical City	Completed	No outcome recorded
Phase 311 trials · 1 met primary · 4 missed
Phase 3	NCT04140214	Jun 2018 → Sep 2024	bronchiectasis	Belfast Health and Social Care Trust	Completed	No outcome recorded
Phase 3	NCT03300648	Jan 2018 → Dec 2023	cerebral malaria	Michigan State University	Completed	No outcome recorded
Phase 3	NCT02782520	Aug 2016 → Oct 2017	—	University Hospital, Grenoble	Completed	No outcome recorded
Phase 3	NCT04812574	Jan 2014 → Apr 2018	female stress incontinence	Turgut Ozal University	Completed	No outcome recorded
Phase 3	NCT01777347	Oct 2012 → Apr 2014	acute bronchiolitis	Assistance Publique - Hôpitaux de Paris	Completed	Missed primary
Phase 3	NCT01271114	Jun 2012 → Dec 2013	infectious disease with sepsis	Hospital General de Ciudad Real	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01028339	Jul 2008 → Jun 2012	traumatic brain injury	Central Directorate of the Army Health Service	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00635141	Mar → Dec 2008	cystic fibrosis	The Hospital for Sick Children	Completed	Met primary
Phase 3	NCT00316004	May 2006 → May 2009	traumatic brain injury	University of Washington	Terminated	Missed primary
Phase 3	NCT00316017	May 2006 → Aug 2009	—	University of Washington	Terminated	Missed primary
Phase 3	NCT00271310	Sep 2000 → Nov 2003	cystic fibrosis	Royal Prince Alfred Hospital, Sydney, Australia	Completed	Missed primary

Phase 412 trials · 1 met primary · 3 missed
Phase 4	NCT04921943	May 2021 → Dec 2025 overdue	pulmonary non-tuberculous mycobacterial infection	Oregon Health and Science University	Recruiting	No outcome recorded
Phase 4	NCT03880903	Jul 2020 → Mar 2021	acute bronchiolitis	Assiut University	Unknown	No outcome recorded
Phase 4	NCT03738735	Jan 2019 → Jan 2020	rotator cuff syndrome	Rothman Institute Orthopaedics	Unknown	No outcome recorded
Phase 4	NCT03324477	Nov 2017 → Dec 2023	urethral syndrome	Nazmy Edward Seif	Completed	No outcome recorded
Phase 4	NCT02266875	Oct 2014 → Jan 2017	chronic obstructive pulmonary disease	OhioHealth	Completed	Missed primary
Phase 4	NCT01973140	Nov 2013 → Dec 2015	—	Northwestern University	Completed	No outcome recorded
Phase 4	NCT01834820	Jan 2013 → Jun 2015	bronchiolitis	Hospital General Naval de Alta Especialidad - Escuela Medico Naval	Completed	No outcome recorded
Phase 4	NCT01745081	Sep 2012 → Sep 2014	intracranial hypertension	University of Sherbrooke	Unknown	No outcome recorded
Phase 4	NCT01871857	Nov 2010 → Aug 2012	acute bronchiolitis	Le Bonheur Children's Hospital	Completed	Missed primary
Phase 4	NCT01247064	Oct 2010 → Dec 2011	bronchiolitis	Children's Hospital of Philadelphia	Completed	Missed primary
Phase 4	NCT01016249	Apr 2007 → Apr 2008	acute bronchiolitis	Hamad Medical Corporation	Completed	Met primary
Phase 4	NCT00469716	Apr 2007 → May 2008	respiratory failure	Haukeland University Hospital	Completed	No outcome recorded

Phase not applicable18 trials · 1 met primary · 1 missed
—	NCT07647575	Oct 2025 → Apr 2028 expected	bronchiectasis, pulmonary non-tuberculous mycobacterial infection	Taipei Veterans General Hospital, Taiwan	Recruiting	No outcome recorded
—	NCT07605273	Jun → Dec 2025	corneal edema	Muhammad Aamir Latif	Completed	No outcome recorded
—	NCT06226402	Sep 2023 → Sep 2024	acute respiratory distress syndrome	Tanta University	Unknown	No outcome recorded
—	NCT04787198	Oct 2022 → Dec 2024	—	Aalborg University	Unknown	No outcome recorded
—	NCT04341688	Dec 2021 → Jun 2022	COVID-19	Aga Khan University	Unknown	No outcome recorded
—	NCT07411950	Jan 2021 → May 2025	chronic pain syndrome, radiculopathy	EPC Education s.r.o.	Completed	No outcome recorded
—	NCT03750136	Dec 2018 → Jan 2023	nephrotic syndrome	Medical University of Bialystok	Unknown	No outcome recorded
—	NCT03940118	Jun 2018 → Apr 2019	tracheal disorder	Hospital San Carlos, Madrid	Completed	No outcome recorded
—	NCT03174483	Jun 2017 → Jun 2018	chronic rhinosinusitis	Assiut University	Unknown	No outcome recorded
—	NCT04001218	Apr → Sep 2015	—	Aalborg University	Completed	No outcome recorded
—	NCT02378467	Mar 2015 → Aug 2018	cystic fibrosis	University of Washington, the Collaborative Health Studies Coordinating Center	Completed	Met primary
—	NCT02834819	Sep 2013 → Sep 2015	bronchiolitis	University of Colorado, Denver	Terminated	No outcome recorded Stop: Business
—	NCT01238848	Dec 2010 → Oct 2011	acute bronchiolitis	Hospital General de Niños Pedro de Elizalde	Completed	No outcome recorded
—	NCT01031706	Sep 2009 → Jul 2012	cystic fibrosis	University of North Carolina, Chapel Hill	Completed	No outcome recorded
—	NCT00709280	Apr 2009 → Oct 2011	cystic fibrosis	CF Therapeutics Development Network Coordinating Center	Completed	Missed primary
—	NCT00546663	Sep 2007 → May 2008	cystic fibrosis	CF Therapeutics Development Network Coordinating Center	Completed	No outcome recorded
—	NCT00199511	Jan 2005 → Apr 2007	primary brain neoplasm	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Completed	No outcome recorded
—	NCT00142090	Nov 2004 → Dec 2005	traumatic brain injury, traumatic encephalopathy	Rady Children's Hospital, San Diego	Completed	No outcome recorded

Comparator or background therapy29 trials
Phase 0	NCT06174584 Comparator	Feb 2021 → Jan 2022	rectal prolapse	Shaheed Zulfiqar Ali Bhutto Medical University	Completed	No outcome recorded
Phase 0	NCT04686344 Comparator	Dec 2020 → Aug 2021	optic nerve disorder	Cairo University	Completed	No outcome recorded
Phase 1	NCT01223183 Comparator	Sep 2010 → Dec 2012	cystic fibrosis	University of Pittsburgh	Completed	No outcome recorded
Phase 1/2	NCT00928135 Comparator	Jan 2013 → Apr 2018	cystic fibrosis	Joseph Zabner	Completed	No outcome recorded
Phase 2	NCT04671407 Comparator	Jan 2021 → Dec 2022	—	Kaplan Medical Center	Unknown	No outcome recorded
Phase 2	NCT02709109 Background	Feb 2016 → Sep 2017	cystic fibrosis	Parion Sciences	Completed	Missed primary
Phase 2	NCT02585531 Comparator	Nov 2015 → Feb 2017	bronchiolitis	Hospital General Naval de Alta Especialidad - Escuela Medico Naval	Unknown	No outcome recorded
Phase 2	NCT01954290 Comparator	Sep 2015	brain edema, stroke disorder	University of Florida	Withdrawn	No outcome recorded
Phase 2	NCT02343445 Background	Apr 2015 → Feb 2016	cystic fibrosis	Parion Sciences	Completed	No outcome recorded
Phase 2	NCT00677729 Comparator	Nov 2008 → Apr 2009	bronchiolitis	Queen's University	Completed	No outcome recorded
Phase 2	NCT00696540 Background	Jun → Sep 2008	bronchiolitis	University Diego Portales	Unknown	No outcome recorded
Phase 3	NCT06110429 Comparator	Jan 2024 → Jun 2025	intracranial hypertension	University Hospital, Geneva	Unknown	No outcome recorded
Phase 3	NCT01111682 Comparator	Apr → Nov 2010	intracranial hypertension, traumatic brain injury	University of Cincinnati	Terminated	No outcome recorded
Phase 3	NCT00484263 Comparator	Dec 2007 → Oct 2009	bronchiectasis	The Alfred	Completed	No outcome recorded
Phase 4	NCT04765033 Comparator	Feb 2021 → Aug 2023	bronchiectasis	University of Malaya	Completed	No outcome recorded
Phase 4	NCT03280745 Comparator	Feb 2018 → May 2019	cardiac valvular defect, cardiovascular disorder	Insel Gruppe AG, University Hospital Bern	Completed	No outcome recorded
Phase 4	NCT02538458 Comparator	Nov 2014 → Mar 2016	acute bronchiolitis	University Hospital, Grenoble	Completed	No outcome recorded
Phase 4	NCT01276821 Comparator	Jan → Apr 2011	bronchiolitis	Dr. Aayush Khanal, MD	Completed	No outcome recorded
Phase 4	NCT01377792 Comparator	Mar 2009 → May 2011	cystic fibrosis	Adelaida Lamas Ferreiro	Completed	No outcome recorded
—	NCT07286409 Comparator	Jan → Dec 2026 expected	acute respiratory distress syndrome	Tanta University	Not yet recruiting	No outcome recorded
—	NCT06069336 Comparator	Nov 2023 → Apr 2025	acute bronchiolitis	Szpital im. Św. Jadwigi Śląskiej	Completed	No outcome recorded
—	NCT04314674 Comparator	Apr 2020 → Apr 2022	adult glioblastoma, metastatic malignant neoplasm in the brain	Istanbul University	Unknown	No outcome recorded
—	NCT04146311 Comparator	Oct 2019 → Nov 2020	osteoarthritis, knee	Aalborg University	Completed	No outcome recorded
—	NCT03741257 Comparator	Nov 2018 → Nov 2019	—	Cairo University	Unknown	No outcome recorded
—	NCT03614273 Comparator	Mar 2015 → Feb 2016	bronchiolitis	Maulana Azad Medical College	Completed	No outcome recorded
—	NCT02460510 Comparator	Jun 2014 → Nov 2015	acute liver failure	Institute of Liver and Biliary Sciences, India	Completed	No outcome recorded
—	NCT01108744 Comparator	Jan 2012 → Jan 2014	intracranial hypertension	Beth Israel Deaconess Medical Center	Withdrawn	No outcome recorded
—	NCT01073527 Comparator	Jan 2009 → Jul 2011	asthma	Wolfson Medical Center	Completed	No outcome recorded
—	NCT00671723 Comparator	Oct 2006 → Jul 2008	lung disorder	University of Oklahoma	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 1

Date	Issuer	Release
2017-10-25	Vertex Pharmaceuticals Incorporated	Results Vertex Reports Third-Quarter 2017 Financial Results vrtx.com ↗ In patients being treated with ORKAMBI, the addition of hypertonic saline resulted in a decrease in ppFEV1 of 0.1 percentage points at Day 28.

All press releases naming this drug 1 release

Date	Issuer	Release
2017-10-25	Vertex Pharmaceuticals Incorporated	Vertex Reports Third-Quarter 2017 Financial Results vrtx.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 90 sources stand behind the page.

Field	Value	Cited text
Known as	hypertonic saline	“Hypertonic saline: Nebulized hypertonic saline has been suggested as a potential therapy for ARDS patients due to its ability to reduce airway inflammation and improve...” NCT07286409 ↗ 88 “Nebulized hypertonic saline (HS) has been shown to increase mucociliary clearance in the airways of individuals with healthy lungs.” NCT01247064 ↗ “After the head fixation 3 mL.kg-1 %3 hypertonic saline will be administered over the 20 min intravenously.” NCT04314674 ↗ “The two hypertonic solutions most commonly used are Mannitol 20% and Hypertonic Saline 7.5%.” NCT00199511 ↗ “Periurethral hypertonic saline (10% NaCl) injection” NCT04812574 ↗ “2% hypertonic saline (Plabottle® by Otsuka Inc.)” PMID 32928313 ↗ Sep 2020 “nebulized hypertonic saline (HS) treatment” PMID 28586918 ↗ Aug 2017 “Hypertonic saline (HTS) is a compound” NCT02432157 ↗ “hypertonic saline (10 mL)” NCT07411950 ↗ “Drug: Hypertonic saline” NCT01355796 ↗ NCT04787198 ↗ Show 78 more sources
Known as	ClNa 3% (sodium chloride 3%)	“ClNa 3% (sodium chloride 3%)” NCT01238848 ↗
Known as	HTS	“There has been substantial retrospective data and limited prospective data in children which suggests that hypertonic saline (HTS) can improve the control of intracranial...” NCT00142090 ↗ 2 “Inhalation of hypertonic saline (HTS) has short term positive effects on airways clearance in non-cystic fibrosis (CF) bronchiectasis, however its long term effects are unknown.” PMID 22349069 ↗ Feb 2012 “Hypertonic saline (HTS) is a compound” NCT02432157 ↗
Known as	Hyper-Sal, inhaled saline	“Hyper-Sal™, inhaled saline” NCT02378467 ↗
Known as	hyperosmolar saline	“Hyperosmolar saline is an irrigation solution with a higher concentration of solutes that will be used intraoperatively to washout the surgical field.” NCT03738735 ↗
Known as	Hypertonic Saline Solution	“Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients” NCT06110429 ↗
Known as	Plabottle	“2% hypertonic saline (Plabottle® by Otsuka Inc.)” PMID 32928313 ↗ Sep 2020
Action	Inhibit	“exerts inhibitory effects in several stages of the inflammatory cascade” NCT06226402 ↗
Route	Intravenous	“3% hypertonic saline (salt-water solution) given in a vein” NCT00142090 ↗