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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
C25H34O6
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

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

Phase 4
Conditions
Infant,Premature
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Interventions
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
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

Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects

Phase 4
Withdrawn
Conditions
Acute Cellular Graft Rejection
Liver Transplant Rejection
Interventions
First Posted Date
2017-10-19
Last Posted Date
2019-09-23
Lead Sponsor
Montefiore Medical Center
Registration Number
NCT03315052

Intratracheal Budesonide/Surfactant Prevents BPD

Phase 4
Completed
Conditions
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Interventions
Drug: Saline
Drug: budesonide
First Posted Date
2017-09-07
Last Posted Date
2023-05-30
Lead Sponsor
Taipei Medical University
Target Recruit Count
310
Registration Number
NCT03275415
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Nebulizer Versus Dry Powdered Inhalers for Chronic Obstructive Pulmonary Disease (COPD)

Phase 4
Terminated
Conditions
COPD Exacerbation
COPD
Interventions
Device: Dry Powder Inhaler
Device: Nebulizers
Drug: Brovana
Drug: Advair Diskus
Drug: Pulmicort
Drug: Spiriva HandiHaler
Drug: Atrovent
First Posted Date
2017-07-18
Last Posted Date
2021-06-22
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
40
Registration Number
NCT03219866
Locations
🇺🇸

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States

The RECONSTRUCT Study - Reconstructing Disease Mechanisms in Asthma

Phase 4
Completed
Conditions
Asthma
Interventions
First Posted Date
2017-01-27
Last Posted Date
2023-02-10
Lead Sponsor
Bispebjerg Hospital
Target Recruit Count
60
Registration Number
NCT03034005
Locations
🇩🇰

Lungemedicinsk forskningsenhed, Bispebjerg Hospital, Kobenhavn, Denmark

Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

Phase 2
Terminated
Conditions
Diarrhea
Interventions
Drug: Placebos
Drug: Entocort
First Posted Date
2016-12-13
Last Posted Date
2019-05-20
Lead Sponsor
Pooja Budhiraja, MD
Target Recruit Count
9
Registration Number
NCT02991768
Locations
🇺🇸

University of Kansas Medical Center, Kansas City, Kansas, United States

A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD

Phase 2
Completed
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Drug: Placebo
Drug: CHF6001
Drug: Budesonide
First Posted Date
2016-12-08
Last Posted Date
2019-01-28
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Target Recruit Count
1130
Registration Number
NCT02986321

Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis

Phase 3
Withdrawn
Conditions
Rhinitis, Allergic, Perennial
Interventions
First Posted Date
2016-11-25
Last Posted Date
2019-10-09
Lead Sponsor
Eurofarma Laboratorios S.A.
Registration Number
NCT02972866
Locations
🇧🇷

Allergisa pesquisa dermato-cosmética ltda, Campinas, São Paulo, Brazil

Inhaled Budesonide for Altitude Illness Prevention

Phase 3
Withdrawn
Conditions
Altitude Sickness
Interventions
Other: Placebo
Drug: Budesonide
First Posted Date
2016-10-21
Last Posted Date
2017-03-13
Lead Sponsor
University of Colorado, Denver
Registration Number
NCT02941510
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