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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

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
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
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.

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
First Posted Date
2008-01-07
Last Posted Date
2010-10-05
Lead Sponsor
Mayo Clinic
Registration Number
NCT00587119

Pulmicort Respules on Relapse Rates After Treatment in the ED

Phase 4
Withdrawn
Conditions
Asthma
Interventions
First Posted Date
2008-01-02
Last Posted Date
2011-09-05
Lead Sponsor
Phoenix Children's Hospital
Registration Number
NCT00584636
Locations
🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome

Phase 4
Completed
Conditions
Obstructive Sleep Apnea
Interventions
Drug: placebo
Drug: Budesonide
First Posted Date
2007-11-19
Last Posted Date
2017-07-11
Lead Sponsor
University of Louisville
Target Recruit Count
62
Registration Number
NCT00560586
Locations
🇺🇸

Kosair Children's Hospital Sleep Center, Louisville, Kentucky, United States

Symbicort Rapihaler Therapeutic Equivalence Study

Phase 3
Completed
Conditions
Bronchial Asthma
Interventions
First Posted Date
2007-09-28
Last Posted Date
2012-08-15
Lead Sponsor
AstraZeneca
Target Recruit Count
742
Registration Number
NCT00536731
Locations
🇵🇱

Research Site, Wroclaw, Poland

Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma

Phase 3
Completed
Conditions
Asthma
Interventions
Drug: Budesonide
Drug: Conventional Asthma Therapy
First Posted Date
2007-07-31
Last Posted Date
2012-08-27
Lead Sponsor
AstraZeneca
Target Recruit Count
241
Registration Number
NCT00509028
Locations
🇯🇵

Research Site, Takizawa, Iwate, Japan

Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma

Phase 3
Completed
Conditions
Asthma
First Posted Date
2007-07-19
Last Posted Date
2011-08-24
Lead Sponsor
AstraZeneca
Target Recruit Count
240
Registration Number
NCT00504062
Locations
🇯🇵

Research Site, Takizawa, Iwate, Japan

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