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

Efficacy of Budesonide Via Delayed Release vs Immediate Release

Early Phase 1

Withdrawn

Conditions: Chronic Rhinosinusitis (Diagnosis)

Interventions: Drug: Budesonide
Device: Mucosal Atomization Device
Device: NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation

First Posted Date: 2020-07-20

Last Posted Date: 2022-07-11

Lead Sponsor: St. Paul's Hospital, Canada

Registration Number: NCT04476628

Coronavirus Smell Therapy for Anosmia Recovery

Phase 2

Withdrawn

Conditions: Anosmia

Interventions: Drug: Budesonide
Behavioral: High-Concentration Essential Oil
Drug: Placebo
Behavioral: Low-Concentration Essential Oil

First Posted Date: 2020-06-09

Last Posted Date: 2021-03-02

Lead Sponsor: Washington University School of Medicine

Registration Number: NCT04422275

Locations: 🇺🇸
Washington University, Saint Louis, Missouri, United States

Assessing Improvement in Cognitive Deficit in CRS in Patients Treated With Medical Vs Surgical Management

Not Applicable

Conditions: Chronic Sinusitis

Interventions: Procedure: Private system endoscopic sinus surgery
Procedure: Public system endoscopic sinus surgery
Drug: Budesonide

First Posted Date: 2020-03-02

Last Posted Date: 2020-03-02

Lead Sponsor: St. Paul's Hospital, Canada

Target Recruit Count: 150

Registration Number: NCT04291118

Locations: 🇨🇦
E.N.T. Clinic, St. Paul's Hospital, Vancouver, British Columbia, Canada

Comparing Budesonide Via MAD or INSI Prospective Cohort Study

Early Phase 1

Conditions: Chronic Rhinosinusitis With Nasal Polyps
Allergic Fungal Sinusitis

Interventions: Drug: Budesonide
Device: Mucosal Atomization Device
Device: NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation

First Posted Date: 2020-02-12

Last Posted Date: 2020-02-12

Lead Sponsor: St. Paul's Hospital, Canada

Target Recruit Count: 60

Registration Number: NCT04267042

The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease

Not Applicable

Conditions: Crohn Disease

Interventions: Dietary Supplement: Modulen
Drug: Budesonide

First Posted Date: 2020-01-18

Last Posted Date: 2020-01-18

Lead Sponsor: Hillel Yaffe Medical Center

Target Recruit Count: 50

Registration Number: NCT04233463

Locations: 🇮🇱
Hillel Yaffe Medical Center, Hadera, Israel

Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)

Phase 2

Completed

Conditions: Chronic Sinusitis

Interventions: Drug: Nitric Oxide
Drug: Budesonide

First Posted Date: 2019-11-15

Last Posted Date: 2022-06-30

Lead Sponsor: Sanotize Research and Development corp.

Target Recruit Count: 56

Registration Number: NCT04163978

Locations: 🇨🇦
St. Paul's Hospital, Vancouver, British Columbia, Canada

A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution

Phase 4

Completed

Conditions: Rhinitis

Interventions: Other: Placebo
Drug: Budesonide

First Posted Date: 2019-10-21

Last Posted Date: 2021-01-22

Lead Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Target Recruit Count: 206

Registration Number: NCT04132570

Locations: 🇨🇳
Beijing Tongren Hospital, Cmu, Beijing, Beijing, China
🇨🇳
The No.2 Hospital of Baoding, Baoding, Hebei, China
🇨🇳
Cangzhou Center Hospital, Cangzhou, Hebei, China

and more 3 locations

Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study

Early Phase 1

Completed

Conditions: Chronic Rhinosinusitis (Diagnosis)

Interventions: Drug: Povidone-Iodine
Drug: Budesonide

First Posted Date: 2019-09-20

Last Posted Date: 2019-09-20

Lead Sponsor: St. Paul's Hospital, Canada

Target Recruit Count: 29

Registration Number: NCT04097613

Locations: 🇨🇦
St. Paul's Hospital, Vancouver, British Columbia, Canada

Cortiment® MMX Pharmacokinetic Study

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Budesonide

First Posted Date: 2019-09-06

Last Posted Date: 2019-10-21

Lead Sponsor: Ferring Pharmaceuticals

Target Recruit Count: 24

Registration Number: NCT04080713

Locations: 🇮🇳
Lambda Therapeutic Research Ltd, Ahmedabad, Gujrat, India

Compare the Effect of INS Alone and Added LTRA in Treatment of SAR

Early Phase 1

Completed

Conditions: Allergic Rhinitis

Interventions: Drug: budesonide

First Posted Date: 2019-09-04

Last Posted Date: 2019-09-04

Lead Sponsor: Beijing Tongren Hospital

Target Recruit Count: 46

Registration Number: NCT04077892

Locations: 🇨🇳
Beijing Tongren Hospital, Beijing, Beijing, China

Drug Development Updates

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