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Last Updated: January 18, 2020

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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 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 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.
NCT00215436 A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD Completed Dey Phase 3 2005-03-01 The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.
NCT00280371 A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL in the Treatment of Patients With COPD Completed Dey Phase 3 2006-01-01 The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.
NCT00308191 A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD Completed Dey Phase 3 2006-04-01 The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Formoterol Fumarate

Condition Name

Condition Name for Formoterol Fumarate
Intervention Trials
Asthma 40
Chronic Obstructive Pulmonary Disease 27
COPD 11
Chronic Obstructive Pulmonary Disease (COPD) 11
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Condition MeSH

Condition MeSH for Formoterol Fumarate
Intervention Trials
Pulmonary Disease, Chronic Obstructive 57
Lung Diseases 49
Lung Diseases, Obstructive 47
Asthma 28
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Clinical Trial Locations for Formoterol Fumarate

Trials by Country

Trials by Country for Formoterol Fumarate
Location Trials
United States 612
China 44
Canada 34
United Kingdom 17
Australia 17
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Trials by US State

Trials by US State for Formoterol Fumarate
Location Trials
Florida 31
South Carolina 30
California 29
Oregon 27
Texas 26
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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 13
Phase 3 51
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Formoterol Fumarate
Clinical Trial Phase Trials
Completed 75
Recruiting 13
Not yet recruiting 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. 28
AstraZeneca 21
Merck Sharp & Dohme Corp. 14
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Sponsor Type

Sponsor Type for Formoterol Fumarate
Sponsor Trials
Industry 118
Other 27
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