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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

Safety and Efficacy of Bronchitol in Bronchiectasis

Phase 3
Completed
Conditions
Bronchiectasis
Interventions
Drug: placebo
First Posted Date
2006-01-16
Last Posted Date
2008-08-29
Lead Sponsor
Syntara
Target Recruit Count
354
Registration Number
NCT00277537
Locations
🇦🇺

Royal Perth Hospital, Perth, Western Australia, Australia

🇬🇧

Belfast City Hospital, Belfast, Northern Ireland, United Kingdom

🇦🇺

St George Hospital, Kogarah, New South Wales, Australia

and more 19 locations

Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics

Phase 3
Completed
Conditions
Asthma
First Posted Date
2005-11-11
Last Posted Date
2009-12-01
Lead Sponsor
Syntara
Target Recruit Count
240
Registration Number
NCT00252291
Locations
🇺🇸

Colorado Asthma and Allergy Centers, 125 Rampart Way, Denver, Colorado, United States

Mannitol Dose Response Study in Cystic Fibrosis

Phase 2
Completed
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2005-11-09
Last Posted Date
2008-08-29
Lead Sponsor
Syntara
Target Recruit Count
48
Registration Number
NCT00251056
Locations
🇨🇦

Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada

🇦🇷

Hospital Pediatrico Dr Humberto J Notti, Mendoza, Argentina

🇦🇷

Hospital de Niños Superiora Sor María Ludovica, La Plata, Buenos Aires, Argentina

and more 9 locations

Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors

Phase 1
Terminated
Conditions
Bone Marrow Suppression
Brain and Central Nervous System Tumors
Drug/Agent Toxicity by Tissue/Organ
Long-term Effects Secondary to Cancer Therapy in Children
First Posted Date
2005-10-13
Last Posted Date
2017-04-21
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
2
Registration Number
NCT00238173
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Antenatal Allopurinol During Fetal Hypoxia

Phase 3
Conditions
Fetal Hypoxia
Reperfusion Injury
Interventions
First Posted Date
2005-09-16
Last Posted Date
2012-03-29
Lead Sponsor
UMC Utrecht
Target Recruit Count
222
Registration Number
NCT00189007
Locations
🇳🇱

UMCG, Groningen, Netherlands

🇳🇱

Gelre hospitals, Apeldoorn, Netherlands

🇳🇱

Jeroen Bosch Hospital, Den Bosch, Netherlands

and more 8 locations

Cerebral Hemodynamic Effects of Hypertonic Solutions in Severely Head-Injured Patients

Terminated
Conditions
Traumatic Brain Injury
Intracranial Hypertension
First Posted Date
2005-07-29
Last Posted Date
2012-06-26
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
10
Registration Number
NCT00125229
Locations
🇺🇸

Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU), San Antonio, Texas, United States

Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

Phase 2
Completed
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2005-07-04
Last Posted Date
2010-02-02
Lead Sponsor
Syntara
Target Recruit Count
20
Registration Number
NCT00117208
Locations
🇬🇧

Great Ormond Hospital for Children, London, United Kingdom

🇬🇧

Royal Brompton Hospital, London, United Kingdom

Mannitol as Adjunct Therapy for Childhood Cerebral Malaria

Phase 3
Conditions
Cerebral Malaria
First Posted Date
2005-06-13
Last Posted Date
2005-06-24
Lead Sponsor
Makerere University
Target Recruit Count
156
Registration Number
NCT00113854
Locations
🇺🇬

Department of Paediatrics and Child Health, Makerere Medical School, Kampala, Uganda

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