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Budesonide

Generic Name
Budesonide
Brand Names
Airsupra, Breyna, Breztri, Cortiment, Entocort, Pulmicort, Pulmicort Turbuhaler, Rhinocort, Symbicort, Tarpeyo, Uceris, Jorveza, Kinpeygo
Drug Type
Small Molecule
Chemical Formula
C25H34O6
CAS Number
51333-22-3
Unique Ingredient Identifier
Q3OKS62Q6X
Background

Budesonide is a glucocorticoid that is a mix of the 22R and 22S epimer used to treat inflammatory conditions of the lungs and intestines such as asthma, COPD, Crohn's disease, and ulcerative colitis.

Budesonide was granted FDA approval on 14 February 1994. It is also available in a combination product with formoterol.

Indication

Budesonide extended release capsules are indicated for the treatment and maintenance of mild to moderate Crohn’s disease. Various inhaled budesonide products are indicated for prophylactic therapy in asthma and to reduce exacerbations of COPD. A budesonide nasal spray is available over the counter for symptoms of hay fever and upper respiratory allergies. Extended-release capsules are indicated to induce remission of mild to moderate ulcerative colitis and a rectal foam is used for mild to moderate distal ulcerative colitis. In addition, a delayed-release capsule formulation of budesonide is indicated to reduce proteinuria in adults with IgA nephropathy at risk of rapid disease progression. In Europe, budesonide is indicated to treat eosinophilic esophagitis (EoE) in adults.

Associated Conditions
Allergic Reaction, Allergic Rhinitis (AR), Asthma, Bronchoconstriction, Chronic Obstructive Pulmonary Disease (COPD), Collagenous Colitis, Crohn's Disease (CD), Eosinophilic Esophagitis, Exacerbation of asthma, Nasal Congestion, Nasal Polyps, Proteinuria, Pruritus, Rhino Sinusitis, Ulcerative Colitis, Vasomotor Rhinitis, Corticosteroid-responsive dermatoses, Mild Crohn’s Disease, Moderate Crohn’s Disease
Associated Therapies
Maintenance therapy

Effects of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease (COPD)

Phase 4
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
First Posted Date
2005-09-20
Last Posted Date
2008-08-13
Lead Sponsor
Queen's University
Target Recruit Count
4
Registration Number
NCT00202189
Locations
🇨🇦

Respiratory Investigation Unit, Kingston, Ontario, Canada

Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children

Phase 4
Completed
Conditions
Asthma
Interventions
Drug: Usual care (albuterol with or without oral steroid)
First Posted Date
2005-09-19
Last Posted Date
2021-02-01
Lead Sponsor
Deborah Gentile
Target Recruit Count
61
Registration Number
NCT00189436
Locations
🇺🇸

Bellevue Pediatric Associates, Bellevue, Pennsylvania, United States

🇺🇸

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

Budesonide for Maintenance Treatment of Collagenous Colitis

Phase 3
Completed
Conditions
Collagenous Colitis
First Posted Date
2005-09-16
Last Posted Date
2010-03-30
Lead Sponsor
Technische Universität Dresden
Target Recruit Count
75
Registration Number
NCT00180076
Locations
🇩🇪

Medical Department I, Technical University Hospital, Dresden, Germany

Budesonide for Prevention of Acute Gastrointestinal GVHD Following Allogenic Stem Cell Transplantation

Phase 3
Completed
Conditions
Leukemia
Graft-Versus-Host Disease
First Posted Date
2005-09-16
Last Posted Date
2010-03-30
Lead Sponsor
Technische Universität Dresden
Target Recruit Count
242
Registration Number
NCT00180089
Locations
🇩🇪

Medical Department I, Technical University Hospital, Dresden, Germany

Budesonide Treatment for Lymphocytic Colitis

Phase 3
Completed
Conditions
Microscopic Colitis
First Posted Date
2005-09-16
Last Posted Date
2010-03-30
Lead Sponsor
Technische Universität Dresden
Target Recruit Count
40
Registration Number
NCT00180050
Locations
🇩🇪

Medical Department I, Technical University Hospital, Dresden, Germany

Treatment of Microscopic Colitis

Not Applicable
Terminated
Conditions
Colitis
Interventions
Drug: Bismuth
Drug: Fiber
First Posted Date
2005-09-16
Last Posted Date
2015-01-21
Lead Sponsor
Norwegian University of Science and Technology
Target Recruit Count
105
Registration Number
NCT00184171
Locations
🇳🇴

Aker sykehus, Oslo, Norway

🇳🇴

Helse NordMøre og Romsdal, Molde, Norway

🇳🇴

Sykehuset Innlandet HF, Lillehammer, Lillehammer, Norway

and more 6 locations

A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide)

Phase 2
Completed
Conditions
Lung Cancer
First Posted Date
2005-09-15
Last Posted Date
2005-09-15
Lead Sponsor
University of British Columbia
Target Recruit Count
120
Registration Number
NCT00175747
Locations
🇨🇦

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

Effect of Symbicort on GR Localisation in Asthma

Not Applicable
Completed
Conditions
Asthma
Interventions
First Posted Date
2005-09-12
Last Posted Date
2019-09-27
Lead Sponsor
Imperial College London
Target Recruit Count
10
Registration Number
NCT00159263
Locations
🇬🇧

Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital, London, United Kingdom

Long-Term Treatment of Collagenous Colitis With Budesonide

Phase 3
Conditions
Collagenous Colitis
First Posted Date
2005-08-31
Last Posted Date
2008-03-06
Lead Sponsor
Bonderup, Ole K., M.D.
Target Recruit Count
36
Registration Number
NCT00139165
Locations
🇩🇰

Dept. of medical gastroenterology, Aarhus, Denmark

A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide

Phase 2
Completed
Conditions
Malignant Melanoma
Interventions
Drug: Ipilimumab+ Placebo
First Posted Date
2005-08-26
Last Posted Date
2016-09-28
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
115
Registration Number
NCT00135408
Locations
🇬🇧

Local Institution, Hull, United Kingdom

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