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. E...

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

Adults With Moderate to Severe Asthma

Phase 3

Completed

Conditions: Asthma

Interventions: Drug: Budesonide

First Posted Date: 2008-03-24

Last Posted Date: 2011-01-24

Lead Sponsor: AstraZeneca

Target Recruit Count: 900

Registration Number: NCT00642122

New Nasal Applicator / New Formulation - User Study

Phase 2

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: Placebo
Device: Budesonide

First Posted Date: 2008-03-24

Last Posted Date: 2011-01-24

Lead Sponsor: AstraZeneca

Target Recruit Count: 200

Registration Number: NCT00641979

New Version Pulmicort Turbuhaler USA Adults

Phase 3

Completed

Conditions: Asthma

Interventions: Drug: budesonide
Drug: Placebo

First Posted Date: 2008-03-24

Last Posted Date: 2011-01-24

Lead Sponsor: AstraZeneca

Target Recruit Count: 525

Registration Number: NCT00642187

Assess the Efficacy and Safety of Rhinocort Aqua

Phase 2

Completed

Conditions: Allergic Rhinitis

Interventions: Drug: Budesonide
Drug: Placebo

First Posted Date: 2008-03-24

Last Posted Date: 2011-01-24

Lead Sponsor: AstraZeneca

Target Recruit Count: 650

Registration Number: NCT00641693

New Version Pulmicort Turbuhaler USA Children

Phase 3

Completed

Conditions: Asthma

First Posted Date: 2008-03-24

Last Posted Date: 2011-01-24

Lead Sponsor: AstraZeneca

Target Recruit Count: 430

Registration Number: NCT00642161

Varicella Vaccination With Pulmicort

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: budesonide
Drug: varicella zoster virus

First Posted Date: 2008-03-24

Last Posted Date: 2009-03-25

Lead Sponsor: AstraZeneca

Target Recruit Count: 250

Registration Number: NCT00641446

Effect of ADC4022 Co-Administered With Budesonide on Pulmonary Inflammation in Subjects With Moderate to Severe COPD

Phase 2

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Theophylline - ADC4022
Drug: Placebo
Drug: Budesonide

First Posted Date: 2008-03-13

Last Posted Date: 2009-03-02

Lead Sponsor: Pulmagen Therapeutics

Target Recruit Count: 91

Registration Number: NCT00634413

Locations: 🇵🇱
Jagiellonian University of Medicine, Krakow, Poland
🇬🇧
The London Chest Hospital, London, United Kingdom
🇬🇧
Glenfield Hospital, Leicester, Leicestershire, United Kingdom

and more 5 locations

Study of the Mechanisms of Asthma

Phase 1

Completed

Conditions: Asthma

Interventions: Drug: Pulmicort

First Posted Date: 2008-01-16

Last Posted Date: 2014-01-20

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 127

Registration Number: NCT00595153

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.

Phase 3

Completed

Conditions: Asthma

Interventions: Drug: Budesonide
Drug: albuterol
Drug: Ipratropium bromide
Drug: Prednisone

First Posted Date: 2008-01-08

Last Posted Date: 2016-01-21

Lead Sponsor: Northwell Health

Target Recruit Count: 95

Registration Number: NCT00588406

Locations: 🇺🇸
Nassau University Medical Center, East Meadow, New York, United States
🇺🇸
Long Island Jewish Medical Center, Queens, New York, United States
🇺🇸
Jacobi Medical Center, Bronx, New York, United States

Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis

Not Applicable

Withdrawn

Conditions: Primary Biliary Cirrhosis
Autoimmune Hepatitis

Interventions: Drug: Budesonide

First Posted Date: 2008-01-07

Last Posted Date: 2010-10-05

Lead Sponsor: Mayo Clinic

Registration Number: NCT00587119

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