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

Therapeutic Approaches to Malnutrition Enteropathy

Phase 2

Completed

Conditions: Severe Acute Malnutrition

Interventions: Dietary Supplement: Colostrum high protein powder (Neovite)
Drug: N-Acetyl Glucosamine (GInNAC)
Drug: Budesonide
Drug: Teduglutide

First Posted Date: 2018-10-23

Last Posted Date: 2021-09-27

Lead Sponsor: Queen Mary University of London

Target Recruit Count: 125

Registration Number: NCT03716115

Locations: 🇿🇼
Harare Central Hospital, Harare, Zimbabwe
🇿🇼
Parirenyatwa Hospital, Harare, Zimbabwe
🇿🇲
University Teaching Hospital, Nationalist Road, Lusaka, Zambia

Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.

Phase 3

Completed

Conditions: Chronic Rhinosinusitis With Polyposis

Interventions: Drug: budesonide
Drug: Prednisone

First Posted Date: 2018-09-27

Last Posted Date: 2018-09-27

Lead Sponsor: Beijing Tongren Hospital

Target Recruit Count: 91

Registration Number: NCT03687515

Diesel Exhaust Induces Glucocorticoid Resistance

Phase 4

Recruiting

Conditions: Glucocorticoid Resistance
Exposure to Pollution

Interventions: Drug: Budesonide
Other: Placebo
Other: Diesel Exhaust
Other: Filtered Air

First Posted Date: 2018-08-06

Last Posted Date: 2024-07-24

Lead Sponsor: University of British Columbia

Target Recruit Count: 30

Registration Number: NCT03615742

Locations: 🇨🇦
University of British Columbia, Vancouver, British Columbia, Canada

Change of Lung Function After Exercise in Patients With Chronic Obstructive Pulmonary Disease

Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive
Exercise
Lung Function Decreased
Quality of Life

Interventions: Drug: Budesonide and formoterol bid

First Posted Date: 2018-06-11

Last Posted Date: 2018-06-20

Lead Sponsor: Zhujiang Hospital

Target Recruit Count: 50

Registration Number: NCT03551197

Locations: 🇨🇳
Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China

Study to Detect Oral Administration of Budesonide in Women.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Budesonide

First Posted Date: 2018-05-25

Last Posted Date: 2018-09-11

Lead Sponsor: Parc de Salut Mar

Target Recruit Count: 4

Registration Number: NCT03537326

Locations: 🇪🇸
IMIM, Barcelona, Spain

Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.

Phase 4

Conditions: Infant,Premature
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia

Interventions: Drug: Budesonide
Drug: Saline
Drug: Poractant Alfa

First Posted Date: 2018-05-11

Last Posted Date: 2019-08-07

Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"

Target Recruit Count: 108

Registration Number: NCT03521063

Locations: 🇲🇽
Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosí, Mexico

Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates

Phase 2

Withdrawn

Conditions: Chronic Sinus Congestion
Chronic Sinus Infection
Chronic Sinusitis
Chronic Sinusitis - Ethmoidal, Posterior

Interventions: Drug: Budesonide

First Posted Date: 2018-05-08

Last Posted Date: 2021-01-14

Lead Sponsor: Kaiser Permanente

Registration Number: NCT03519061

Locations: 🇺🇸
Kaiser Permanante Orange County, Irvine, California, United States

To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

Phase 3

Completed

Conditions: Colitis, Ulcerative

Interventions: Drug: Budesonide (6 mg)
Drug: Mesalazine (3,600 mg)
Drug: Budesonide (9 mg)

First Posted Date: 2018-01-26

Last Posted Date: 2020-06-18

Lead Sponsor: Ferring Pharmaceuticals

Target Recruit Count: 274

Registration Number: NCT03412682

Locations: 🇯🇵
Ferring Investigator Site JPN59, Hakodate-shi, Hokkaido, Japan
🇯🇵
Ferring Investigator Site JPN11, Asahikawa-shi, Hokkaido, Japan
🇯🇵
Ferring Investigator Site JPN27, Nagoya-shi, Aichi, Japan

and more 69 locations