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. 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

SOIBD Collagenous Colitis Maintenance Study

First Posted Date
2011-01-17
Last Posted Date
2016-01-21
Lead Sponsor
Dr. Falk Pharma GmbH
Target Recruit Count
92
Registration Number
NCT01278082
Locations
🇩🇪

Center of digestive diseases, Hamburg, Germany

🇸🇪

University Hospital of Linköping, Linköping, Sweden

NasoNeb Delivery of an Intranasal Steroid

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-01-05
Last Posted Date
2014-07-25
Lead Sponsor
University of Chicago
Target Recruit Count
41
Registration Number
NCT01270256
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.

First Posted Date
2010-12-29
Last Posted Date
2010-12-29
Lead Sponsor
East Carolina University
Target Recruit Count
45
Registration Number
NCT01268215
Locations
🇺🇸

NICU-Pitt County Memorial Hospital, Greenville, North Carolina, United States

Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)

First Posted Date
2010-12-03
Last Posted Date
2021-01-19
Lead Sponsor
National Jewish Health
Target Recruit Count
46
Registration Number
NCT01253473
Locations
🇺🇸

Reliant Medical Group, Worcester, Massachusetts, United States

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

National Jewish Health, Denver, Colorado, United States

and more 4 locations

Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

First Posted Date
2010-09-27
Last Posted Date
2017-07-26
Lead Sponsor
Dr. Falk Pharma GmbH
Target Recruit Count
57
Registration Number
NCT01209208
Locations
🇩🇪

Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf, Hamburg, Germany

AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-09-13
Last Posted Date
2011-11-15
Lead Sponsor
Activaero GmbH
Registration Number
NCT01200108
Locations
🇩🇪

Peter, Kardos, MD, Frankfurt, Germany

Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-09-09
Last Posted Date
2018-05-29
Lead Sponsor
University of Michigan
Target Recruit Count
23
Registration Number
NCT01197612
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-06-03
Last Posted Date
2014-08-01
Lead Sponsor
AstraZeneca
Target Recruit Count
304
Registration Number
NCT01136382
Locations
🇿🇦

Research Site, Panorama, W Cape, South Africa

(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-04-08
Last Posted Date
2019-11-29
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
61
Registration Number
NCT01100112
Locations
🇮🇳

Santarus Clinical Investigational Site 9015, Karnataka, India

🇮🇳

Santarus Clinical Investigational Site 9001, Andhra Pradesh, India

🇮🇳

Santarus Clinical Investigational Site 9009, Andhra Pradesh, India

and more 12 locations

9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-03-15
Last Posted Date
2014-10-30
Lead Sponsor
Dr. Falk Pharma GmbH
Target Recruit Count
471
Registration Number
NCT01086553
Locations
🇩🇪

Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken, Frankfurt, Germany

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