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Last Updated: May 28, 2022

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 Completed Simbec Research Phase 1 2019-04-04 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 Completed AstraZeneca Phase 1 2019-04-04 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.
NCT00000577 ↗ Asthma Clinical Research Network (ACRN) Withdrawn National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Budesonide

Condition Name

Condition Name for Budesonide
Intervention Trials
Asthma 143
Chronic Obstructive Pulmonary Disease 21
Eosinophilic Esophagitis 14
Chronic Obstructive Pulmonary Disease (COPD) 10
[disabled in preview] 0
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Condition MeSH

Condition MeSH for Budesonide
Intervention Trials
Asthma 146
Lung Diseases 52
Pulmonary Disease, Chronic Obstructive 51
Lung Diseases, Obstructive 45
[disabled in preview] 0
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Clinical Trial Locations for Budesonide

Trials by Country

Trials by Country for Budesonide
Location Trials
United States 840
China 112
Canada 101
Germany 71
United Kingdom 43
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Trials by US State

Trials by US State for Budesonide
Location Trials
California 51
North Carolina 37
Texas 36
Florida 35
Pennsylvania 34
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Clinical Trial Progress for Budesonide

Clinical Trial Phase

Clinical Trial Phase for Budesonide
Clinical Trial Phase Trials
Phase 4 101
Phase 3 125
Phase 2/Phase 3 14
[disabled in preview] 72
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Clinical Trial Status

Clinical Trial Status for Budesonide
Clinical Trial Phase Trials
Completed 272
Unknown status 36
Recruiting 32
[disabled in preview] 27
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Clinical Trial Sponsors for Budesonide

Sponsor Name

Sponsor Name for Budesonide
Sponsor Trials
AstraZeneca 96
Dr. Falk Pharma GmbH 20
GlaxoSmithKline 14
[disabled in preview] 10
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Sponsor Type

Sponsor Type for Budesonide
Sponsor Trials
Other 334
Industry 279
NIH 20
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