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
Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis
- Conditions
- Primary Biliary CirrhosisAutoimmune 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
- 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
- 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
A Study of 2 Doses of MAP0010 in Adult Asthmatics
- Conditions
- Asthma
- Interventions
- Drug: MAP0010 low doseDrug: MAP0010 high dose
- First Posted Date
- 2007-11-07
- Last Posted Date
- 2014-01-09
- Lead Sponsor
- Allergan
- Target Recruit Count
- 32
- Registration Number
- NCT00554970
- Locations
- 🇺🇸
West Coast Clinical Trials Phase 2-4, LLC, Long Beach, California, United States
Symbicort Rapihaler Therapeutic Equivalence Study
- 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
Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children
- Conditions
- Asthma
- Interventions
- Device: Nitric Oxide Analyzer
- First Posted Date
- 2007-08-30
- Last Posted Date
- 2009-01-23
- Lead Sponsor
- AAADRS Clinical Research Center
- Target Recruit Count
- 16
- Registration Number
- NCT00522782
- Locations
- 🇺🇸
AAADRS Clinical Research Center, Coral Gables, Florida, United States
Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
- 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
- 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
Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma
- Conditions
- Asthma
- First Posted Date
- 2007-06-22
- Last Posted Date
- 2007-06-28
- Lead Sponsor
- Medical University of Lodz
- Target Recruit Count
- 150
- Registration Number
- NCT00490243
- Locations
- 🇵🇱
Department of Pediatrics and Allergy, Medical University of Lodz, Poland, Lodz, Poland
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma
- Conditions
- Asthma
- Interventions
- First Posted Date
- 2007-06-19
- Last Posted Date
- 2010-04-13
- Lead Sponsor
- Medical University of Lodz
- Target Recruit Count
- 96
- Registration Number
- NCT00487773
- Locations
- 🇵🇱
Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
Drug Development Updates
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