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Mannitol

Generic Name
Mannitol
Brand Names
Aridol, Bronchitol, Cystosol, Osmitrol, Sag-M
Drug Type
Small Molecule
Chemical Formula
C6H14O6
CAS Number
69-65-8
Unique Ingredient Identifier
3OWL53L36A
Background

Mannitol is an osmotic diuretic that is metabolically inert in humans and occurs naturally, as a sugar or sugar alcohol, in fruits and vegetables. Mannitol elevates blood plasma osmolality, resulting in enhanced flow of water from tissues, including the brain and cerebrospinal fluid, into interstitial fluid and plasma. As a result, cerebral edema, elevated intracranial pressure, and cerebrospinal fluid volume and pressure may be reduced. Mannitol may also be used for the promotion of diuresis before irreversible renal failure becomes established; the promotion of urinary excretion of toxic substances; as an Antiglaucoma agent; and as a renal function diagnostic aid.

On October 30, 2020, mannitol was approved by the FDA as add-on maintenance therapy for the control of pulmonary symptoms associated with cystic fibrosis in adult patients and is currently marketed for this indication under the name BRONCHITOL® by Chiesi USA Inc.

Indication

Used for the promotion of diuresis before irreversible renal failure becomes established, the reduction of intracranial pressure, the treatment of cerebral edema, and the promotion of urinary excretion of toxic substances.

Mannitol is also indicated as add-on maintenance therapy for improving pulmonary function in cystic fibrosis patients aged 18 and over who have passed the BRONCHITOL tolerance test (BTT). It is recommended that patients take an orally inhaled short-acting bronchodilator 5-15 minutes prior to every inhaled mannitol dose.

Associated Conditions
Acute Renal Failure (ARF), Cystic Fibrosis (CF), Edema of the cerebrum, Increased Intra Ocular Pressure (IOP)
Associated Therapies
Bladder irrigation therapy

Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP).

Not Applicable
Withdrawn
Conditions
Elevated Intracranial Pressure
Interventions
Drug: hypertonic saline
First Posted Date
2010-04-22
Last Posted Date
2017-03-16
Lead Sponsor
Beth Israel Deaconess Medical Center
Registration Number
NCT01108744
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

High Dose Inhaled Mannitol Study

Phase 1
Completed
Conditions
Bronchiectasis
First Posted Date
2010-02-26
Last Posted Date
2010-02-26
Lead Sponsor
Syntara
Target Recruit Count
10
Registration Number
NCT01076491
Locations
🇦🇺

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Comparison of Two Doses of Mannitol on Brain Relaxation During Supratentorial Craniotomy

Not Applicable
Completed
Conditions
Brain Tumor
Intracranial Pressure
Interventions
First Posted Date
2010-01-14
Last Posted Date
2011-05-05
Lead Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Target Recruit Count
80
Registration Number
NCT01048684
Locations
🇨🇦

Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame, Montreal, Quebec, Canada

Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values

Phase 3
Terminated
Conditions
Traumatic Brain Injury
Interventions
Drug: Hypertonic saline
First Posted Date
2009-12-09
Last Posted Date
2012-08-08
Lead Sponsor
Direction Centrale du Service de Santé des Armées
Target Recruit Count
30
Registration Number
NCT01028339
Locations
🇫🇷

HIA Sainte Anne, Toulon, France

Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors

Phase 1
Conditions
Germ Cell Tumor
Recurrent Medulloblastoma
Embryonal Tumor With Multilayered Rosettes, C19MC-Altered
Medulloblastoma
Medulloepithelioma
Recurrent Malignant Germ Cell Tumor
Recurrent Primitive Neuroectodermal Tumor
Primitive Neuroectodermal Tumor
Central Nervous System Embryonal Neoplasm
Recurrent Childhood Central Nervous System Embryonal Neoplasm
Interventions
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
First Posted Date
2009-09-24
Last Posted Date
2021-10-26
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
17
Registration Number
NCT00983398
Locations
🇺🇸

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Phase 1
Conditions
Severe Head Trauma
Interventions
First Posted Date
2008-12-18
Last Posted Date
2010-12-08
Lead Sponsor
Abela Pharmaceuticals, Inc.
Target Recruit Count
30
Registration Number
NCT00810940
Locations
🇺🇸

University of California, Irvine, Irvine, California, United States

🇺🇸

Boston University Medical Center, Boston, Massachusetts, United States

🇺🇸

Ohio State University, Columbus, Ohio, United States

Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

Phase 1
Completed
Conditions
Cystic Fibrosis
First Posted Date
2008-11-18
Last Posted Date
2010-02-02
Lead Sponsor
Syntara
Target Recruit Count
18
Registration Number
NCT00792714
Locations
🇬🇧

Southampton General Hospital, Southampton, United Kingdom

🇬🇧

Sheffield Children's Clinical Foundation, Sheffield, United Kingdom

🇦🇺

Mater Adult Hospital, Brisbane, Queensland, Australia

and more 1 locations

Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation

Phase 4
Conditions
Diabetic Retinopathy
Interventions
First Posted Date
2008-05-14
Last Posted Date
2008-05-14
Lead Sponsor
Federal University of São Paulo
Target Recruit Count
30
Registration Number
NCT00677664
Locations
🇧🇷

Federal University of Sao Paulo, Sao Paulo, SP, Brazil

Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis

Phase 3
Completed
Conditions
Bronchiectasis
Interventions
Drug: Matched control
First Posted Date
2008-04-30
Last Posted Date
2016-04-29
Lead Sponsor
Syntara
Target Recruit Count
485
Registration Number
NCT00669331
Locations
🇺🇸

University of Miami, Miami, Florida, United States

🇺🇸

Florida Pulmonary Research, Winter Park, Florida, United States

🇺🇸

The University of Chicago Hospitals, Chicago, Illinois, United States

and more 80 locations

Long Term Administration of Inhaled Mannitol in Cystic Fibrosis

Phase 3
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: Placebo comparator
First Posted Date
2008-03-07
Last Posted Date
2020-10-09
Lead Sponsor
Syntara
Target Recruit Count
318
Registration Number
NCT00630812
Locations
🇺🇸

John Hopkins, Baltimore, Maryland, United States

🇺🇸

University of Missouri, Columbia, Missouri, United States

🇺🇸

University of Washington medical centre, Seattle, Washington, United States

and more 50 locations
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