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Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR UMECLIDINIUM BROMIDE


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All Clinical Trials for Umeclidinium Bromide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01313637 ↗ A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD Completed GlaxoSmithKline Phase 3 2011-03-01 This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).
NCT01772134 ↗ Efficacy and Safety of the Addition of Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide (62.5 or 125mcg) Once-daily Over 12 Weeks Completed GlaxoSmithKline Phase 3 2013-01-01 The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.
NCT01772147 ↗ Efficacy and Safety of the Addition of Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide Inhalation Powder (62.5 or 125mcg) Once-daily Over 12 Weeks. Completed GlaxoSmithKline Phase 3 2013-01-01 The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily and umeclidinium bromide (125mcg) once-daily to fluticasone propionate (250/50mcg) twice-daily with placebo when added to fluticasone propionate (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Umeclidinium Bromide

Condition Name

Condition Name for Umeclidinium Bromide
Intervention Trials
Pulmonary Disease, Chronic Obstructive 15
Asthma 3
Chronic Obstructive Pulmonary Disease 2
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Condition MeSH

Condition MeSH for Umeclidinium Bromide
Intervention Trials
Pulmonary Disease, Chronic Obstructive 17
Lung Diseases 17
Chronic Disease 14
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Clinical Trial Locations for Umeclidinium Bromide

Trials by Country

Trials by Country for Umeclidinium Bromide
Location Trials
United States 181
Germany 80
Canada 28
United Kingdom 27
China 26
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Trials by US State

Trials by US State for Umeclidinium Bromide
Location Trials
North Carolina 10
South Carolina 10
Louisiana 9
Florida 9
California 9
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Clinical Trial Progress for Umeclidinium Bromide

Clinical Trial Phase

Clinical Trial Phase for Umeclidinium Bromide
Clinical Trial Phase Trials
Phase 4 3
Phase 3 13
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Umeclidinium Bromide
Clinical Trial Phase Trials
Completed 18
Not yet recruiting 1
Withdrawn 1
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Clinical Trial Sponsors for Umeclidinium Bromide

Sponsor Name

Sponsor Name for Umeclidinium Bromide
Sponsor Trials
GlaxoSmithKline 18
Novartis Pharmaceuticals 2
York Bioanalytical Solution 1
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Sponsor Type

Sponsor Type for Umeclidinium Bromide
Sponsor Trials
Industry 22
Other 4
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