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

Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi

Phase 1

Completed

Conditions: Rhinosinusitis
Chronic Polyposis

Interventions: Drug: Budesonide

First Posted Date: 2013-09-20

Last Posted Date: 2022-04-12

Lead Sponsor: Pari Pharma GmbH

Target Recruit Count: 14

Registration Number: NCT01946711

Locations: 🇩🇪
HNO-Zentrum Mangfall-Inn, Rosenheim, Germany
🇩🇪
University LMU Munich, Munich, Germany
🇩🇪
University Göttingen, Göttingen, Germany

and more 1 locations

Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma

Phase 4

Terminated

Conditions: Severe IgE-mediated Asthma

Interventions: Drug: Omalizumab
Drug: Budesonide
Drug: Formoterol

First Posted Date: 2013-07-31

Last Posted Date: 2019-07-02

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 112

Registration Number: NCT01912872

Locations: 🇲🇽
Novartis Investigative Site, Mérida, Yucatán, Mexico

Evaluation of Inhaled Treatment in Sinusitis

Phase 2

Completed

Conditions: Sinusitis

Interventions: Drug: methylprednisolone
Drug: Budesonide

First Posted Date: 2013-07-24

Last Posted Date: 2014-01-27

Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Target Recruit Count: 50

Registration Number: NCT01907204

Comparison of Efficacy of Nebulizing Budesonide and Intravenous Dexamethasone Before Extubation on Prevention of Post-extubation Complications in Intensive Care Unit Patients

Not Applicable

Conditions: Respiratory Sounds

Interventions: Drug: Dexamethasone acetate
Drug: Budesonide

First Posted Date: 2013-05-15

Last Posted Date: 2013-05-15

Lead Sponsor: Saeed Abbasi

Target Recruit Count: 90

Registration Number: NCT01854515

Locations: 🇮🇷
Alzahra University Hospital, Isfahan, Iran, Islamic Republic of

Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis

Phase 4

Completed

Conditions: Eosinophilic Esophagitis

Interventions: Behavioral: six-foods elimination diet
Drug: Oral Viscous Budesonide (OVB)
Drug: Fluticasone
Drug: Budesonide

First Posted Date: 2013-05-06

Last Posted Date: 2018-05-11

Lead Sponsor: Azienda Policlinico Umberto I

Target Recruit Count: 64

Registration Number: NCT01846962

Locations: 🇮🇹
Departments of Pediatrics, Sapienza - University of Rome, Rome, Italy

Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients

Not Applicable

Conditions: Respiratory Sounds

Interventions: Drug: Budesonide
Drug: placebo

First Posted Date: 2013-02-07

Last Posted Date: 2013-02-07

Lead Sponsor: Isfahan University of Medical Sciences

Target Recruit Count: 70

Registration Number: NCT01786070

Locations: 🇮🇷
Alzahra University Hospital, Isfahan, Iran, Islamic Republic of

LIPS-B: Lung Injury Prevention Study With Budesonide and Beta

Phase 2

Completed

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Interventions: Drug: Budesonide
Drug: Placebo
Drug: Formoterol

First Posted Date: 2013-02-05

Last Posted Date: 2016-09-05

Lead Sponsor: Mayo Clinic

Target Recruit Count: 61

Registration Number: NCT01783821

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Stanford University, Stanford, California, United States
🇺🇸
University of Arizona, Tucson, Arizona, United States

and more 2 locations