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: C_₂₅H_₃₄O_₆

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

Clinical Trials

Short- and Long Term Growth in Children With Asthma

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: Montelukast
Drug: Budesonide

First Posted Date: 2006-09-26

Last Posted Date: 2008-02-27

Lead Sponsor: Children´s Clinic, Randers

Target Recruit Count: 52

Registration Number: NCT00380484

Locations: 🇩🇰
Children's Clinic Randers, Randers, Denmark

Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: TPI-1020
Drug: budesonide

First Posted Date: 2006-05-19

Last Posted Date: 2012-12-03

Lead Sponsor: Syntara

Target Recruit Count: 27

Registration Number: NCT00327808

Locations: 🇨🇦
Montreal Chest Institute, Montreal, Quebec, Canada
🇨🇦
McMaster University Hospital, Hamilton, Ontario, Canada
🇨🇦
CARL, Laval, Quebec, Canada

and more 4 locations

Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Other: Placebo
Drug: Budesonide

First Posted Date: 2006-05-04

Last Posted Date: 2016-01-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 225

Registration Number: NCT00321893

Locations: 🇮🇹
European Institute of Oncology, Milan, Italy

Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

Phase 3

Completed

Conditions: Crohn's Disease

Interventions: Drug: budesonide
Drug: mesalazine

First Posted Date: 2006-03-08

Last Posted Date: 2014-05-19

Lead Sponsor: Dr. Falk Pharma GmbH

Target Recruit Count: 311

Registration Number: NCT00300118

Locations: 🇩🇪
Ev. Krankenhaus Hattingen GmbH, Hattingen, Germany

Budesonide for Eosinophilic Esophagitis

Phase 2

Completed

Conditions: Eosinophilic Esophagitis

First Posted Date: 2005-12-30

Last Posted Date: 2015-05-22

Lead Sponsor: Swiss EE Study Group

Target Recruit Count: 28

Registration Number: NCT00271349

Locations: 🇨🇭
Department of Gastroenterology, Kantonsspital, Olten, Solothurn, Switzerland

SHARE - Symbicort and Health Economics in a Real Life Evaluation

Phase 3

Completed

Conditions: Asthma

First Posted Date: 2005-12-01

Last Posted Date: 2011-01-24

Lead Sponsor: AstraZeneca

Target Recruit Count: 1970

Registration Number: NCT00259766

Locations: 🇸🇪
Reseearch Site, Perstorp, Sweden
🇸🇪
Research Site, Örebro, Sweden
🇸🇪
Research site, Ödeshög, Sweden

Efficacy & Safety of Symbicort® TURBUHALER® 160/4.5 µg Twice Daily & Pulmicort® TURBUHALER® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese Asthmatic Patients

Phase 3

Completed

Conditions: Asthma

First Posted Date: 2005-11-15

Last Posted Date: 2011-01-24

Lead Sponsor: AstraZeneca

Target Recruit Count: 340

Registration Number: NCT00252785

Locations: 🇯🇵
Research Site, Toyama, Japan

Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Phase 2

Terminated

Conditions: Lymphocytic Colitis
Diarrhea

Interventions: Drug: Budesonide
Other: Placebo

First Posted Date: 2005-09-22

Last Posted Date: 2021-11-02

Lead Sponsor: Mayo Clinic

Target Recruit Count: 16

Registration Number: NCT00217022

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Effects of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease (COPD)

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Budesonide

First Posted Date: 2005-09-20

Last Posted Date: 2008-08-13

Lead Sponsor: Queen's University

Target Recruit Count: 4

Registration Number: NCT00202189

Locations: 🇨🇦
Respiratory Investigation Unit, Kingston, Ontario, Canada

Treatment of Microscopic Colitis

Not Applicable

Terminated

Conditions: Colitis

Interventions: Drug: Bismuth
Drug: Fiber
Drug: Budesonide

First Posted Date: 2005-09-16

Last Posted Date: 2015-01-21

Lead Sponsor: Norwegian University of Science and Technology

Target Recruit Count: 105

Registration Number: NCT00184171

Locations: 🇳🇴
Aker sykehus, Oslo, Norway
🇳🇴
Helse NordMøre og Romsdal, Molde, Norway
🇳🇴
Sykehuset Innlandet HF, Lillehammer, Lillehammer, Norway

and more 6 locations

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