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: C_₂₅H_₃₄O_₆

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

Clinical Trials

A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers With Charcoal Block

Phase 1

Completed

Conditions: Asthma
Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Drug: Budesonide
Drug: Formoterol

First Posted Date: 2016-08-01

Last Posted Date: 2016-08-01

Lead Sponsor: Intech Biopharm Ltd.

Target Recruit Count: 99

Registration Number: NCT02850484

Bioequivalence Study of Budesonide Rectal Aerosol Foam and Uceris® Rectal Aerosol Foam

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Budesonide
Drug: Uceris

First Posted Date: 2016-06-15

Last Posted Date: 2022-01-13

Lead Sponsor: Padagis LLC

Registration Number: NCT02800824

The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

Phase 4

Completed

Conditions: Rhinosinusitis
Chronic Eosinophilic Rhinosinusitis
Allergic Rhinosinusitis

Interventions: Drug: Saline alone
Drug: Budesonide

First Posted Date: 2016-03-02

Last Posted Date: 2019-09-03

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 80

Registration Number: NCT02696850

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Altitude Sickness Prevention and Efficacy of Comparative Treatments

Phase 3

Completed

Conditions: Acute Mountain Sickness

Interventions: Drug: Acetazolamide
Drug: Placebo
Drug: Budesonide

First Posted Date: 2015-11-13

Last Posted Date: 2018-12-12

Lead Sponsor: Stanford University

Target Recruit Count: 103

Registration Number: NCT02604173

Locations: 🇺🇸
Owens Valley Lodge - White Mountain Research Station, Bishop, California, United States

The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery

Not Applicable

Completed

Conditions: Chronic Sinusitis
Nasal Polyposis

Interventions: Device: MEDIHONEY®
Drug: Budesonide
Drug: Normal saline sinus rinse
Drug: Prednisone
Procedure: Endoscopic sinus surgery
Drug: nasal saline spray