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 Nebulized Budesonide and Intranasal Budesonide Spray in Children With Adenotonsillar Hypertrophy

Phase 3

Not yet recruiting

Conditions: Mouth Breathing
Snoring

Interventions: Drug: Intranasal Budesonide Spray
Drug: Nebulized Budesonide

First Posted Date: 2022-04-13

Last Posted Date: 2022-04-22

Lead Sponsor: Second Xiangya Hospital of Central South University

Target Recruit Count: 100

Registration Number: NCT05325489

Locations: 🇨🇳
Department of Otolaryngology, Second Xiangya Hospital, Central South University, Changsha, Hunan, China

BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient

Phase 3

Completed

Conditions: Asthma

Interventions: Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg
Drug: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol
Drug: Placebo

First Posted Date: 2022-04-12

Last Posted Date: 2023-08-30

Lead Sponsor: Cipla Ltd.

Target Recruit Count: 1485

Registration Number: NCT05322707

Locations: 🇺🇸
Velocity Clinical Research, Medford, Oregon, United States

Vitamin D Nasal Drops in Post COVID-19 Parosmia

Phase 2

Conditions: Parosmia

Interventions: Drug: Vitamin D3
Drug: Budesonide nasal spray

First Posted Date: 2022-03-07

Last Posted Date: 2022-05-11

Lead Sponsor: Menoufia University

Target Recruit Count: 60

Registration Number: NCT05269017

Locations: 🇪🇬
Menoufia Faculty of Medicine, Shibīn Al Kawm, Menoufia, Egypt

Ivermectin Nasal Drops in Post COVID-19 Parosmia

Phase 2

Conditions: Parosmia

Interventions: Drug: Ivermectin Topical
Drug: Budesonide Nasal

First Posted Date: 2022-03-07

Last Posted Date: 2022-05-11

Lead Sponsor: Menoufia University

Target Recruit Count: 60

Registration Number: NCT05269030

Locations: 🇪🇬
Menoufia Faculty of Medicine, Shibīn Al Kawm, Menoufia, Egypt

Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE)

Phase 2

Withdrawn

Conditions: Eosinophilic Esophagitis

Interventions: Drug: Budesonide Gel

First Posted Date: 2022-01-28

Last Posted Date: 2024-08-23

Lead Sponsor: Bazell Pharma AG

Registration Number: NCT05214599

Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: Budesonide 200 microgram/Puff, HFA MDI
Drug: Budesonide 100 microgram/Actuation Powder for Inhalation

First Posted Date: 2021-12-09

Last Posted Date: 2021-12-09

Lead Sponsor: Intech Biopharm Ltd.

Target Recruit Count: 270

Registration Number: NCT05152355

Locations: 🇨🇳
The Second Hospital of Hebei Medical University, Shijia Zhuang, He Bei Sheng, China
🇨🇳
Bao Gang Hospital, Baotou, Inner Mongolia, China
🇨🇳
The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, China

and more 10 locations