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

Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma

Phase 4

Terminated

Conditions: Exercise Induced Asthma

Interventions: Drug: Budesonide/Formoterol
Drug: Budesonide

First Posted Date: 2010-02-18

Last Posted Date: 2021-07-07

Lead Sponsor: Boston Children's Hospital

Target Recruit Count: 6

Registration Number: NCT01070888

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Children's Hospital Boston, Boston, Massachusetts, United States

Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

Phase 3

Completed

Conditions: Bronchopulmonary Dysplasia

Interventions: Drug: Budesonide

First Posted Date: 2009-12-18

Last Posted Date: 2016-07-06

Lead Sponsor: University Children's Hospital Tuebingen

Target Recruit Count: 863

Registration Number: NCT01035190

Locations: 🇨🇿
University Hospital of Tomas Bati, Department of Neonatology, Zlin, Czech Republic
🇫🇮
Tampere University Hospita, NICU, Tampere, Finland
🇳🇱
Erasmus MC - Sophia, Department of Neonatology, Rotterdam, Netherlands

and more 37 locations

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

Phase 3

Completed

Conditions: Proctosigmoiditis
Proctitis

Interventions: Drug: Budesonide
Drug: Placebo

First Posted Date: 2009-11-05

Last Posted Date: 2019-08-14

Lead Sponsor: Bausch Health Americas, Inc.

Target Recruit Count: 265

Registration Number: NCT01008410

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

Phase 3

Completed

Conditions: Proctitis
Proctosigmoiditis

Interventions: Drug: Placebo
Drug: Budesonide

First Posted Date: 2009-11-05

Last Posted Date: 2019-08-14

Lead Sponsor: Bausch Health Americas, Inc.

Target Recruit Count: 281

Registration Number: NCT01008423

Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

Phase 2

Completed

Conditions: Exercise Induced Asthma

Interventions: Drug: budesonide/formoterol
Drug: budesonide
Drug: terbutaline

First Posted Date: 2009-10-06

Last Posted Date: 2012-08-14

Lead Sponsor: AstraZeneca

Target Recruit Count: 66

Registration Number: NCT00989833

Locations: 🇸🇪
Research Site, Uppsala, Sweden

Compare CE-Budesonide Nasal Solution & Rhinocort Aqua in an EEC Study of AR

Phase 2

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: Budesonide
Drug: Placebo

First Posted Date: 2009-07-14

Last Posted Date: 2012-10-04

Lead Sponsor: Ligand Pharmaceuticals

Target Recruit Count: 65

Registration Number: NCT00938613

Locations: 🇨🇦
Allied Research International - Cetero Research, Mississauga, Ontario, Canada

Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)

Phase 3

Completed

Conditions: Oral Chronic Graft vs Host Disease

Interventions: Drug: Placebo
Drug: Budesonide

First Posted Date: 2009-04-23

Last Posted Date: 2016-01-21

Lead Sponsor: Dr. Falk Pharma GmbH

Target Recruit Count: 186

Registration Number: NCT00887263

Locations: 🇩🇪
University of Regensburg, Regensburg, Germany
🇮🇱
The Hebrew University-Hadassah School of Dental Medicine, Department of Oral Medicine, Jerusalem, Israel