You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2024

CLINICAL TRIALS PROFILE FOR BUDESONIDE; FORMOTEROL FUMARATE


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Budesonide; Formoterol Fumarate

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 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; Formoterol Fumarate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00476099 ↗ Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD Completed Chiesi Farmaceutici S.p.A. Phase 3 2006-12-01 To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.
NCT00569712 ↗ Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol Completed Astra Zeneca Canada Phase 1 2007-01-01 RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00569712 ↗ Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol Completed AstraZeneca Phase 1 2007-01-01 RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
NCT00569712 ↗ Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol Completed British Columbia Cancer Agency Phase 1 2007-01-01 RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory from patients receiving budesonide and formoterol may help doctors learn more about the effect of budesonide and formoterol on gene expression and biomarkers. PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung cancer, or with asthma treated with budesonide and formoterol.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Budesonide; Formoterol Fumarate

Condition Name

Condition Name for Budesonide; Formoterol Fumarate
Intervention Trials
Asthma 14
Chronic Obstructive Pulmonary Disease 6
Chronic Obstructive Pulmonary Disease (COPD) 3
COPD (Chronic Obstructive Pulmonary Disease) 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Budesonide; Formoterol Fumarate
Intervention Trials
Pulmonary Disease, Chronic Obstructive 14
Lung Diseases 13
Lung Diseases, Obstructive 11
Asthma 11
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Budesonide; Formoterol Fumarate

Trials by Country

Trials by Country for Budesonide; Formoterol Fumarate
Location Trials
United States 181
China 48
Canada 28
Korea, Republic of 10
Taiwan 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Budesonide; Formoterol Fumarate
Location Trials
California 10
South Carolina 9
Oregon 8
North Carolina 8
Missouri 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Budesonide; Formoterol Fumarate

Clinical Trial Phase

Clinical Trial Phase for Budesonide; Formoterol Fumarate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 15
Phase 2 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Budesonide; Formoterol Fumarate
Clinical Trial Phase Trials
Completed 18
Recruiting 6
Not yet recruiting 4
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Budesonide; Formoterol Fumarate

Sponsor Name

Sponsor Name for Budesonide; Formoterol Fumarate
Sponsor Trials
AstraZeneca 12
Chiesi Farmaceutici S.p.A. 3
Orion Corporation, Orion Pharma 3
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Budesonide; Formoterol Fumarate
Sponsor Trials
Industry 31
Other 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.