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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

Change in Airway Responsiveness After Allergen Exposure

Not Applicable
Completed
Conditions
Allergic Asthma
Interventions
First Posted Date
2012-10-03
Last Posted Date
2015-04-09
Lead Sponsor
University of Saskatchewan
Target Recruit Count
11
Registration Number
NCT01699594
Locations
🇨🇦

University of Saskatchewan, Saskatoon, Saskatchewan, Canada

Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

Phase 4
Completed
Conditions
Asthma
Interventions
First Posted Date
2012-07-17
Last Posted Date
2016-10-27
Lead Sponsor
University of Saskatchewan
Target Recruit Count
20
Registration Number
NCT01642745
Locations
🇨🇦

University of Saskatchewan, Saskatoon, Saskatchewan, Canada

Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes

Phase 3
Completed
Conditions
Renal Cancer
Interventions
Other: placebo
First Posted Date
2012-05-28
Last Posted Date
2018-10-15
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
210
Registration Number
NCT01606787
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension

Phase 2
Completed
Conditions
Intra-dialytic Hypotension
Interventions
Drug: 0.9% saline
First Posted Date
2012-01-27
Last Posted Date
2019-01-30
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
52
Registration Number
NCT01520207
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

Phase 4
Completed
Conditions
Asthma
Interventions
First Posted Date
2011-10-10
Last Posted Date
2012-08-09
Lead Sponsor
Mundipharma AB
Target Recruit Count
97
Registration Number
NCT01449123
Locations
🇸🇪

Näsets Läkargrupp i Höllviken, Höllviken, Sweden

Anti-inflammatory Pulmonal Therapy of Cystic Fibrosis (CF) Patients With Amitriptyline and Placebo

Phase 2
Conditions
Cystic Fibrosis
Pneumonia
Interventions
First Posted Date
2011-03-07
Last Posted Date
2011-03-07
Lead Sponsor
University Children's Hospital Tuebingen
Target Recruit Count
30
Registration Number
NCT01309178
Locations
🇩🇪

Lutz Naehrlich, Giessen, Germany

🇩🇪

Joachim Riethmueller, Tuebingen, Germany

🇩🇪

Jochen Mainz, Jena, Germany

Boron Phenylalanine With or Without Mannitol in Treating Patients With Glioblastoma Multiforme

Phase 1
Terminated
Conditions
Brain and Central Nervous System Tumors
First Posted Date
2010-11-03
Last Posted Date
2013-10-08
Lead Sponsor
Cancer Research UK
Target Recruit Count
36
Registration Number
NCT01233492
Locations
🇬🇧

Cancer Research UK Clinical Trials Unit - Birmingham, Birmingham, England, United Kingdom

🇬🇧

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom

Osmotic Therapy for Treatment of Intracranial Hypertension for Traumatic Brain Injury

Not Applicable
Withdrawn
Conditions
Traumatic Brain Injury
Interventions
Drug: NaCl
First Posted Date
2010-10-05
Last Posted Date
2013-04-04
Lead Sponsor
Indiana University
Registration Number
NCT01215019
Locations
🇺🇸

Wishard Memorial Hospital, Indianapolis, Indiana, United States

Wheeze and Intermittent Treatment

Phase 3
Completed
Conditions
Wheezing
Interventions
First Posted Date
2010-06-11
Last Posted Date
2014-04-29
Lead Sponsor
Queen Mary University of London
Target Recruit Count
1358
Registration Number
NCT01142505
Locations
🇬🇧

Barts and the London NHS Trust, London, United Kingdom

Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

Phase 3
Terminated
Conditions
Traumatic Brain Injury
Elevated Intracranial Pressure
Interventions
Drug: Hypertonic Saline
First Posted Date
2010-04-27
Last Posted Date
2013-03-05
Lead Sponsor
University of Cincinnati
Target Recruit Count
5
Registration Number
NCT01111682
Locations
🇺🇸

University Hospital, Cincinnati, Ohio, United States

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