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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR FORMOTEROL FUMARATE


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

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00139932 ↗ Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272) Completed Integrated Therapeutics Group Phase 4 2005-09-01 This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
NCT00139932 ↗ Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272) Completed Novartis Phase 4 2005-09-01 This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
NCT00139932 ↗ Tiotropium Bromide Alone vs Tiotropium Bromide and Formoterol Fumarate in Subjects With COPD (Study P04272) Completed Merck Sharp & Dohme Corp. Phase 4 2005-09-01 This study is being conducted to determine if the co-administration of formoterol fumarate and tiotropium bromide is more effective than the use of tiotropium bromide alone in patients with COPD.
NCT00215358 ↗ Study in Patients With Asthma Completed Dey Phase 2 2002-07-01 The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control drug.
NCT00215371 ↗ Study in Patients With Asthma Completed Dey Phase 2 2002-07-01 The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.
NCT00215384 ↗ Study in Patients With COPD Completed Dey Phase 2 1969-12-31 The purpose of this study is to determine which dose of the investigational drug is the most safe and effective compared to the control drug.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Formoterol Fumarate

Condition Name

Condition Name for Formoterol Fumarate
Intervention Trials
Asthma 52
Chronic Obstructive Pulmonary Disease 31
COPD 17
Chronic Obstructive Pulmonary Disease (COPD) 12
[disabled in preview] 0
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Condition MeSH

Condition MeSH for Formoterol Fumarate
Intervention Trials
Pulmonary Disease, Chronic Obstructive 63
Lung Diseases 53
Lung Diseases, Obstructive 51
Asthma 51
[disabled in preview] 0
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Clinical Trial Locations for Formoterol Fumarate

Trials by Country

Trials by Country for Formoterol Fumarate
Location Trials
United States 807
China 52
Canada 48
Hungary 28
Germany 25
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Trials by US State

Trials by US State for Formoterol Fumarate
Location Trials
California 39
Oregon 39
South Carolina 37
Florida 37
Texas 33
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Clinical Trial Progress for Formoterol Fumarate

Clinical Trial Phase

Clinical Trial Phase for Formoterol Fumarate
Clinical Trial Phase Trials
Phase 4 18
Phase 3 59
Phase 2/Phase 3 2
[disabled in preview] 51
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Clinical Trial Status

Clinical Trial Status for Formoterol Fumarate
Clinical Trial Phase Trials
Completed 107
Not yet recruiting 8
Withdrawn 6
[disabled in preview] 10
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Clinical Trial Sponsors for Formoterol Fumarate

Sponsor Name

Sponsor Name for Formoterol Fumarate
Sponsor Trials
Chiesi Farmaceutici S.p.A. 33
AstraZeneca 26
Dey 18
[disabled in preview] 33
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Sponsor Type

Sponsor Type for Formoterol Fumarate
Sponsor Trials
Industry 143
Other 34
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