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. 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

Clinical Trials

Comparison of Preoperative Inhaled Budesonide With Salbutamol on the Respiratory Adverse Effects in Children Undergoing Tonsillectomy

Phase 4

Not yet recruiting

Conditions: Preoperative Inhalation of Budesonide and Salbutamol in Children Undergoing Tonsillectomy

Interventions: Other: Saline
Drug: Salbutamol
Drug: Budesonide

First Posted Date: 2023-12-06

Last Posted Date: 2023-12-06

Lead Sponsor: Assiut University

Target Recruit Count: 87

Registration Number: NCT06158893

Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis

Phase 4

Active, not recruiting

Conditions: Sinus Infection
Acute Sinusitis

Interventions: Drug: Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet
Drug: Placebo
Other: C-reactive protein
Drug: Budesonide nasal spray

First Posted Date: 2023-10-10

Last Posted Date: 2025-01-10

Lead Sponsor: Daniel Merenstein

Target Recruit Count: 3720

Registration Number: NCT06076304

Locations: 🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States
🇺🇸
MedStar Health Research Institute, Hyattsville, Maryland, United States

and more 4 locations

Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

Phase 4

Not yet recruiting

Conditions: Ulcerative Colitis

Interventions: Drug: High dose budesonide rectal foam
Drug: Low dose budesonide rectal foam
Drug: Matching placebo rectal foam

First Posted Date: 2023-08-04

Last Posted Date: 2023-08-04

Lead Sponsor: Bausch Health Americas, Inc.

Target Recruit Count: 100

Registration Number: NCT05976802

The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis

Phase 2

Completed

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Interventions: Drug: Budesonide
Drug: Saline
Drug: Prednisone

First Posted Date: 2023-07-05

Last Posted Date: 2023-07-05

Lead Sponsor: Kafrelsheikh University

Target Recruit Count: 120

Registration Number: NCT05931744

Locations: 🇪🇬
Kafrelsheikh University hospital, Kafrelsheikh, Egypt

Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis

Phase 2

Not yet recruiting

Conditions: Microscopic Colitis

Interventions: Drug: Budesonide controlled ileal release (CR) capsules
Drug: Budesonide MMX®

First Posted Date: 2023-06-22

Last Posted Date: 2023-12-04

Lead Sponsor: University of Calgary

Target Recruit Count: 80

Registration Number: NCT05915104

Effect of Incentive Spirometery on Asthmatic Pregnant Women

Not Applicable

Completed

Conditions: Asthmatic
Pregnant With Complication

Interventions: Drug: pulmicort inhaler
Device: Incentive spirometer treatment

First Posted Date: 2023-06-15

Last Posted Date: 2023-06-15

Lead Sponsor: Cairo University

Target Recruit Count: 60

Registration Number: NCT05904002

Locations: 🇪🇬
Outpatient clinic faculty of physical therapy cairo university, Dokki, Egypt

Dupilumab in Chinese Adult Participants With CRSwNP

Phase 3

Completed

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Interventions: Drug: Placebo
Drug: Dupilumab
Drug: Budesonide

First Posted Date: 2023-05-26

Last Posted Date: 2024-12-17

Lead Sponsor: Sanofi

Target Recruit Count: 63

Registration Number: NCT05878093

Locations: 🇨🇳
Investigational Site Number : 1560016, Jinan, China
🇨🇳
Investigational Site Number : 1560001, Beijing, China
🇨🇳
Investigational Site Number : 1560010, Chengdu, China

and more 15 locations

Predicting Post Extubation Stridor After Maxillomandibular Fixation

Not Applicable

Recruiting

Conditions: Stridor
Larynx Edema

Interventions: Drug: normal saline
Drug: budesonide

First Posted Date: 2023-05-03

Last Posted Date: 2024-02-06

Lead Sponsor: Mansoura University

Target Recruit Count: 62

Registration Number: NCT05839756

Locations: 🇪🇬
Maha Ahmed AboZeid, Mansoura, Egypt

Combination of Diet and Oral Budesonide for Ulcerative Colitis

Not Applicable

Recruiting

Conditions: Ulcerative Colitis
Ulcerative Colitis Chronic Moderate
Ulcerative Colitis Chronic Mild

Interventions: Other: free diet
Other: Ulcerative colitis Exclusion Diet
Other: Partial enteral nutrition (PEN)
Drug: Oral Budesonide

First Posted Date: 2023-03-30

Last Posted Date: 2024-05-23

Lead Sponsor: Wolfson Medical Center

Target Recruit Count: 90

Registration Number: NCT05791487

Locations: 🇨🇭
Kantonsspital St. Gallen, Saint Gallen, Switzerland
🇮🇱
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
🇮🇱
Emek Medical Center, Afula, Israel

and more 3 locations

Evaluation of Efficacy, Safety and Patient' Satisfaction of Therapeutic Switch From Off-Steroids to Budesonide

Completed

Conditions: Eosinophilic Esophagitis

First Posted Date: 2022-10-26

Last Posted Date: 2024-07-22

Lead Sponsor: Istituto Clinico Humanitas

Target Recruit Count: 31

Registration Number: NCT05594849

Locations: 🇮🇹
Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milano, Italy

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