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

Factors Influencing the Prognosis of Olfactory Dysfunction After Upper Sensation

Phase 2

Not yet recruiting

Conditions: Outcome

Interventions: Drug: budesonide atomization suspension
Drug: methylprednisolone

First Posted Date: 2021-06-09

Last Posted Date: 2021-06-09

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 90

Registration Number: NCT04918953

Locations: 🇨🇳
Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

Replication of the D58 Asthma Trial in Healthcare Claims Data

Completed

Conditions: Asthma

Interventions: Drug: Budesonide-Formoterol
Drug: Budesonide

First Posted Date: 2021-05-19

Last Posted Date: 2023-07-27

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 66581

Registration Number: NCT04892732

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

Phase 3

Not yet recruiting

Conditions: Bronchopulmonary Dysplasia
Prematurity
Respiratory Distress Syndrome in Premature Infant

Interventions: Drug: Poractant Alfa Intratracheal Suspension [Curosurf]
Drug: Budesonide 0.5 MG/ML

First Posted Date: 2021-04-28

Last Posted Date: 2021-09-13

Lead Sponsor: Hospital Clinic of Barcelona

Target Recruit Count: 50

Registration Number: NCT04862377

Bioequivalence Study of Budesonide From Ekmasonid 9 mg Extended Release FCT (Hikma Pharma, Egypt) Versus Uceris 9 mg Extended Release Tablets (Man. for: Salix Pharm., a Division of Valeant Pharm. LLC, USA, by: Cosmo S.P.A., Italy by License of Cosmo Tech. Ltd., Ireland, Product of France)

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Ekmasonid
Drug: Uceris (first dose)
Drug: Uceris (second dose)

First Posted Date: 2021-04-22

Last Posted Date: 2021-04-22

Lead Sponsor: Genuine Research Center, Egypt

Target Recruit Count: 30

Registration Number: NCT04854538

Locations: 🇪🇬
Genuine Research Center GRC, Cairo, Egypt

To Compare the Pharmacokinetics of Budesonide Delivered by BDA MDI to Budesonide Delivered by Pulmicort Respules in Children With Asthma Aged 4 to 8 Years.

Phase 1

Completed

Conditions: Asthma

Interventions: Drug: BDA MDI (PT027) 160/180 μg
Drug: Pulmicort Respules 0.5 MG/ML Inhalation Suspension

First Posted Date: 2021-04-19

Last Posted Date: 2022-05-11

Lead Sponsor: Bond Avillion 2 Development LP

Target Recruit Count: 12

Registration Number: NCT04848662

Locations: 🇺🇸
IPS Research, Oklahoma City, Oklahoma, United States
🇺🇸
TTS Research, Boerne, Texas, United States

Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms

Phase 3

Recruiting

Conditions: Covid19
SARS-Associated Coronavirus

Interventions: Dietary Supplement: Spirulin Platensis
Drug: Fluoxetine 20 MG
Drug: Budesonide Powder
Drug: Placebo

First Posted Date: 2021-01-27

Last Posted Date: 2024-05-08

Lead Sponsor: Cardresearch

Target Recruit Count: 7819

Registration Number: NCT04727424

Locations: 🇧🇷
City of Governador Valadares, Governador Valadares, MG, Brazil
🇧🇷
Centro Universitário FIPMOC, Montes Claros, Minas Gerais, Brazil
🇧🇷
City of Betim, Betim, MG, Brazil

and more 9 locations

Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Moderate Asthma Exacerbation

Phase 3

Terminated

Conditions: Asthma in Children

Interventions: Drug: nebulisation of terbutaline
Drug: Budesonide Formoterol Drug Combination

First Posted Date: 2021-01-12

Last Posted Date: 2023-07-27

Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Target Recruit Count: 102

Registration Number: NCT04705727

Locations: 🇫🇷
CHU Ambroise Paré, Boulogne-Billancourt, France
🇫🇷
CHU Lille, Lille, France
🇫🇷
Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France

and more 5 locations

Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis

Not Applicable

Conditions: Allergic Rhinitis

Interventions: Drug: Budesonide
Drug: Montelukast
Drug: Azelastine
Drug: Placebo

First Posted Date: 2020-09-24

Last Posted Date: 2020-09-25

Lead Sponsor: Shiraz University of Medical Sciences

Target Recruit Count: 66

Registration Number: NCT04561687

Locations: 🇮🇷
Shiraz University of Medical Science, Shiraz, Iran, Islamic Republic of

The Budesonide in Babies (BiB) Trial

Phase 3

Active, not recruiting

Conditions: Bronchopulmonary Dysplasia (BPD)
Respiratory Distress Syndrome
Prematurity; Extreme
Neonatal

Interventions: Drug: budesonide (Pulmicort nebulizing suspension).
Drug: surfactant (poractant alfa;Curosurf)

First Posted Date: 2020-09-11

Last Posted Date: 2025-03-25

Lead Sponsor: NICHD Neonatal Research Network

Target Recruit Count: 1160

Registration Number: NCT04545866

Locations: 🇺🇸
Research Institute at Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸
Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
🇺🇸
University of Texas Health Science Center at Houston, Houston, Texas, United States

and more 16 locations

A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block

Phase 1

Completed

Conditions: Asthma
COPD

Interventions: Drug: Budesonide
Drug: Formoterol

First Posted Date: 2020-07-31

Last Posted Date: 2020-07-31

Lead Sponsor: Intech Biopharm Ltd.

Target Recruit Count: 99

Registration Number: NCT04494321

Locations: 🇨🇳
Clinical Pharmacology Unit of Mackay Memorial Hospital Tamshui Branch, New Taipei City, Taiwan

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