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
C25H34O6
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

Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol

First Posted Date
2012-03-15
Last Posted Date
2013-06-17
Lead Sponsor
AstraZeneca
Target Recruit Count
353
Registration Number
NCT01555099
Locations
🇺🇦

Research Site, Zaporizhzhya, Ukraine

The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-02-01
Last Posted Date
2014-03-13
Lead Sponsor
King Saud University
Target Recruit Count
945
Registration Number
NCT01524198
Locations
🇸🇦

King Fahad Medical City, Riyadh, Saudi Arabia

Study of Inhaled RNS60 in Combination With Budesonide to Treat Mild to Moderate Asthma

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-01-18
Last Posted Date
2014-07-28
Lead Sponsor
Revalesio Corporation
Target Recruit Count
65
Registration Number
NCT01511302
Locations
🇺🇸

California Allergy and Asthma, Los Angeles, California, United States

🇺🇸

Axis Clinical Trials, Los Angeles, California, United States

🇺🇸

West Coast Clinical Trials, Costa Mesa, California, United States

and more 1 locations

Role of microRNAs in T Cell-Driven Inflammation in Asthma

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2011-12-02
Last Posted Date
2022-06-24
Lead Sponsor
University of California, San Francisco
Target Recruit Count
55
Registration Number
NCT01484691
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Pharmacokinetic Pilot Study on Budesonide/Formoterol

First Posted Date
2011-10-24
Last Posted Date
2012-02-03
Lead Sponsor
Orion Corporation, Orion Pharma
Target Recruit Count
17
Registration Number
NCT01457716
Locations
🇩🇪

Parexel International GmbH, Berlin, Germany

Safety and Maintenance Study of Entocort for Children With Crohn's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-10-18
Last Posted Date
2022-01-06
Lead Sponsor
Padagis LLC
Target Recruit Count
55
Registration Number
NCT01453946
Locations
🇵🇱

Research Site, Łódź, Poland

Safety Study of Entocort for Children With Crohn's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-09-30
Last Posted Date
2022-01-06
Lead Sponsor
Padagis LLC
Target Recruit Count
123
Registration Number
NCT01444092
Locations
🇵🇱

Research Site, Łódź, Poland

New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-05-25
Last Posted Date
2014-03-11
Lead Sponsor
AstraZeneca
Target Recruit Count
214
Registration Number
NCT01360021
Locations
🇷🇺

Research Site, Moscow, Russia, Russian Federation

Improvement of FeNO and FEF25-75 After Inhaled Corticosteroid Treatment of Asthma

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-04-22
Last Posted Date
2011-04-22
Lead Sponsor
Chungbuk National University
Target Recruit Count
93
Registration Number
NCT01340118
Locations
🇰🇷

Chungbuk National University Hospital, Cheongju, Chungbuk, Korea, Republic of

© Copyright 2024. All Rights Reserved by MedPath