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Last Updated: December 12, 2024

CLINICAL TRIALS PROFILE FOR SEREVENT


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505(b)(2) Clinical Trials for Serevent

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 NCT02254226 ↗ Pharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers Completed Boehringer Ingelheim Phase 1 2004-11-01 1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg Serevent ® MDI with sufficient precision so that in combination with a second trial it can be demonstrated that the systemic drug exposure of a new formulation of salmeterol xinafoate is not superior to that of Serevent ® MDI 2. To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI 3. To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Serevent

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00102882 ↗ Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate Completed GlaxoSmithKline Phase 4 2004-10-01 This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.
NCT00115492 ↗ Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations Completed GlaxoSmithKline Phase 4 2004-12-01 This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.
NCT00144911 ↗ ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Tra Completed GlaxoSmithKline Phase 4 2004-10-01 This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Serevent

Condition Name

Condition Name for Serevent
Intervention Trials
Asthma 12
Pulmonary Disease, Chronic Obstructive 9
Chronic Obstructive Pulmonary Disease 4
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Condition MeSH

Condition MeSH for Serevent
Intervention Trials
Pulmonary Disease, Chronic Obstructive 15
Lung Diseases, Obstructive 15
Lung Diseases 15
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Clinical Trial Locations for Serevent

Trials by Country

Trials by Country for Serevent
Location Trials
United States 189
Italy 24
Canada 13
Argentina 7
Germany 4
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Trials by US State

Trials by US State for Serevent
Location Trials
North Carolina 9
California 9
Missouri 8
Florida 8
South Carolina 7
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Clinical Trial Progress for Serevent

Clinical Trial Phase

Clinical Trial Phase for Serevent
Clinical Trial Phase Trials
Phase 4 13
Phase 3 3
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Serevent
Clinical Trial Phase Trials
Completed 26
Terminated 2
Recruiting 1
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Clinical Trial Sponsors for Serevent

Sponsor Name

Sponsor Name for Serevent
Sponsor Trials
GlaxoSmithKline 10
Boehringer Ingelheim 6
Sunovion 3
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Sponsor Type

Sponsor Type for Serevent
Sponsor Trials
Industry 24
Other 22
NIH 1
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