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

Efficacy of Budesonide Via Delayed Release vs Immediate Release

Early Phase 1

Withdrawn

Conditions: Chronic Rhinosinusitis (Diagnosis)

Interventions: Drug: Budesonide
Device: Mucosal Atomization Device
Device: NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation

First Posted Date: 2020-07-20

Last Posted Date: 2022-07-11

Lead Sponsor: St. Paul's Hospital, Canada

Registration Number: NCT04476628

Coronavirus Smell Therapy for Anosmia Recovery

Phase 2

Withdrawn

Conditions: Anosmia

Interventions: Drug: Budesonide
Behavioral: High-Concentration Essential Oil
Drug: Placebo
Behavioral: Low-Concentration Essential Oil

First Posted Date: 2020-06-09

Last Posted Date: 2021-03-02

Lead Sponsor: Washington University School of Medicine

Registration Number: NCT04422275

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

STerOids in COVID-19 Study

Phase 2

Terminated

Conditions: Coronavirus Infection

Interventions: Drug: Budesonide dry powder inhaler

First Posted Date: 2020-06-04

Last Posted Date: 2021-02-08

Lead Sponsor: University of Oxford

Target Recruit Count: 146

Registration Number: NCT04416399

Locations: 🇬🇧
Oxford Respiratory Trials Unit, Oxford, Oxfordshire, United Kingdom

Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity

Phase 3

Completed

Conditions: SARS-CoV-2
Olfaction Disorders
Anosmia
Budesonide

Interventions: Other: Physiological serum
Drug: Budesonide Nasal

First Posted Date: 2020-04-24

Last Posted Date: 2021-08-03

Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Target Recruit Count: 120

Registration Number: NCT04361474

Locations: 🇫🇷
Amélie YAvchitz, Paris, France

Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Phase 4

Completed

Conditions: Coronavirus Infection

Interventions: Drug: Inhaled budesonide

First Posted Date: 2020-04-21

Last Posted Date: 2021-09-22

Lead Sponsor: Sara Varea

Target Recruit Count: 120

Registration Number: NCT04355637

Locations: 🇦🇷
Hospital San Juan de Dios, La plata, Argentina
🇪🇸
Hospital Clinic of Barcelona, Barcelona, Spain
🇪🇸
Hospital Universitari Vall d'Hebron, Barcelona, Spain

and more 11 locations

Epigenetic Health Benefits of Budesonide

Phase 4

Active, not recruiting

Conditions: Epigenetic Effects of Intranasal Steroids
Environmental Exposure

Interventions: Drug: Budesonide Nasal
Other: Placebo

First Posted Date: 2020-04-10

Last Posted Date: 2025-03-27

Lead Sponsor: University of British Columbia

Target Recruit Count: 20

Registration Number: NCT04342039

Locations: 🇨🇦
University of British Columbia, Vancouver, British Columbia, Canada

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Phase 4

Recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: Placebo
Drug: Low Dose Budesonide
Drug: High Dose Budesonide

First Posted Date: 2020-03-19

Last Posted Date: 2023-10-10

Lead Sponsor: Bausch Health Americas, Inc.

Target Recruit Count: 70

Registration Number: NCT04314375

Locations: 🇺🇸
Bausch Health Site 008, Garden Grove, California, United States
🇺🇸
Bausch Health Site 003, Indianapolis, Indiana, United States
🇺🇸
Bausch Health Site 006, Bronx, New York, United States

and more 1 locations

Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

Phase 2

Active, not recruiting

Conditions: Chronic GVHD

Interventions: Drug: Ibrutinib
Diagnostic Test: ECG
Diagnostic Test: PFT's
Diagnostic Test: CT
Drug: Steroid pulse (prednisone)
Drug: Voriconazole
Drug: Posaconazole
Drug: Azithromycin
Drug: Montelukast
Drug: Budesonide
Drug: Beclomethasone
Other: Filgrastim
Other: Pegfilgrastim
Other: Erythropoietin
Other: Transfusions
Procedure: Oral/Skin biopsy

First Posted Date: 2020-03-04

Last Posted Date: 2025-01-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 10

Registration Number: NCT04294641

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
🇺🇸
Washington University, School of Medicine, Saint Louis, Missouri, United States

Assessing Improvement in Cognitive Deficit in CRS in Patients Treated With Medical Vs Surgical Management

Not Applicable

Conditions: Chronic Sinusitis

Interventions: Procedure: Private system endoscopic sinus surgery
Procedure: Public system endoscopic sinus surgery
Drug: Budesonide

First Posted Date: 2020-03-02

Last Posted Date: 2020-03-02

Lead Sponsor: St. Paul's Hospital, Canada

Target Recruit Count: 150

Registration Number: NCT04291118

Locations: 🇨🇦
E.N.T. Clinic, St. Paul's Hospital, Vancouver, British Columbia, Canada

Comparing Budesonide Via MAD or INSI Prospective Cohort Study

Early Phase 1

Conditions: Chronic Rhinosinusitis With Nasal Polyps
Allergic Fungal Sinusitis

Interventions: Drug: Budesonide
Device: Mucosal Atomization Device
Device: NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation

First Posted Date: 2020-02-12

Last Posted Date: 2020-02-12

Lead Sponsor: St. Paul's Hospital, Canada

Target Recruit Count: 60

Registration Number: NCT04267042

Drug Development Updates

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