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
Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
- First Posted Date
- 2007-06-07
- Last Posted Date
- 2012-12-03
- Lead Sponsor
- Syntara
- Target Recruit Count
- 62
- Registration Number
- NCT00483743
- Locations
- 🇨🇦
CHUS -Hopital FLEURIMONT, Sherbrooke, Quebec, Canada
🇨🇦Clinique Medical Les Saules, Les Saules, Quebec, Canada
🇨🇦Firestone Institute for Respiratory Health, Hamilton, Ontario, Canada
Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
- First Posted Date
- 2007-05-21
- Last Posted Date
- 2021-10-29
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Target Recruit Count
- 828
- Registration Number
- NCT00476099
- Locations
- 🇫🇷
Thomas Similowski, Paris, France
Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)
- Conditions
- Asthma
- First Posted Date
- 2007-05-10
- Last Posted Date
- 2016-07-29
- Target Recruit Count
- 210
- Registration Number
- NCT00471809
- Locations
- 🇺🇸
University of Arizona College of Medicine, Tucson, Arizona, United States
🇺🇸Los Angeles, Kaiser Permanente Allergy Department, Los Angeles, California, United States
🇺🇸University of Wisconsin - Madison, Madison, Wisconsin, United States
Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction
- First Posted Date
- 2007-04-19
- Last Posted Date
- 2009-10-21
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Target Recruit Count
- 18
- Registration Number
- NCT00462592
- Locations
- 🇨🇦
Hospital for Sick Children, Toronto, Ontario, Canada
🇨🇦Hamilton Health Sciences-McMaster University, Hamilton, Ontario, Canada
Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
- Conditions
- Collagenous Colitis
- Interventions
- First Posted Date
- 2007-03-21
- Last Posted Date
- 2014-05-19
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Target Recruit Count
- 92
- Registration Number
- NCT00450086
- Locations
- 🇩🇪
Center of digestive diseases, Hamburg, Germany
A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects
- Conditions
- Asthma
- First Posted Date
- 2007-03-20
- Last Posted Date
- 2011-01-24
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 123
- Registration Number
- NCT00449527
- Locations
- 🇺🇸
Research Site, Tacoma, Washington, United States
A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects
- Conditions
- Asthma
- First Posted Date
- 2007-03-20
- Last Posted Date
- 2011-01-24
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 134
- Registration Number
- NCT00449501
- Locations
- 🇺🇸
Research Site, Spokane, Washington, United States
A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)
- Conditions
- Asthma
- Interventions
- First Posted Date
- 2007-03-01
- Last Posted Date
- 2024-05-20
- Lead Sponsor
- Organon and Co
- Target Recruit Count
- 180
- Registration Number
- NCT00442117
Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: budesonide/formoterol (Symbicort)
- First Posted Date
- 2007-01-11
- Last Posted Date
- 2009-03-27
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 315
- Registration Number
- NCT00421122
- Locations
- 🇨🇳
Research Site, Hangzhou, Zhejiang, China
A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
- Conditions
- Asthma
- Interventions
- Drug: Budesonide/formoterol (SYMBICORT) pMDI
- First Posted Date
- 2007-01-09
- Last Posted Date
- 2012-10-30
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 742
- Registration Number
- NCT00419952
- Locations
- 🇺🇸
Research Site, Springfield, Virginia, United States
Drug Development Updates
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