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Last Updated: February 28, 2021

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CLINICAL TRIALS PROFILE FOR BUDESONIDE

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505(b)(2) Clinical Trials for Budesonide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00641979 New Nasal Applicator / New Formulation - User Study Completed AstraZeneca Phase 2 2002-04-01 The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
New Combination NCT03906045 A Scintigraphy Study of PT010 in COPD Patients Not yet recruiting Simbec Research Phase 1 2019-04-11 This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination NCT03906045 A Scintigraphy Study of PT010 in COPD Patients Not yet recruiting AstraZeneca Phase 1 2019-04-11 This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Budesonide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000575 Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed CAMP Steering Committee Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
NCT00000575 Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV (CAMPCS/3) Completed Johns Hopkins Bloomberg School of Public Health Phase 3 1991-09-01 The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Budesonide

Condition Name

Condition Name for Budesonide
Intervention Trials
Asthma 124
Chronic Obstructive Pulmonary Disease 18
Eosinophilic Esophagitis 13
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Condition MeSH

Condition MeSH for Budesonide
Intervention Trials
Asthma 106
Lung Diseases 48
Pulmonary Disease, Chronic Obstructive 48
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Clinical Trial Locations for Budesonide

Trials by Country

Trials by Country for Budesonide
Location Trials
United States 640
China 93
Canada 86
Germany 62
Italy 40
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Trials by US State

Trials by US State for Budesonide
Location Trials
California 41
North Carolina 31
Pennsylvania 30
Florida 29
Texas 28
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Clinical Trial Progress for Budesonide

Clinical Trial Phase

Clinical Trial Phase for Budesonide
Clinical Trial Phase Trials
Phase 4 86
Phase 3 110
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for Budesonide
Clinical Trial Phase Trials
Completed 200
Not yet recruiting 55
Recruiting 48
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Clinical Trial Sponsors for Budesonide

Sponsor Name

Sponsor Name for Budesonide
Sponsor Trials
AstraZeneca 89
Dr. Falk Pharma GmbH 20
GlaxoSmithKline 14
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Sponsor Type

Sponsor Type for Budesonide
Sponsor Trials
Other 245
Industry 239
NIH 17
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