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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR UMECLIDINIUM BROMIDE

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Clinical Trials for Umeclidinium Bromide

Trial ID Title Status Sponsor Phase Summary
NCT01313637 A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD Completed GlaxoSmithKline Phase 3 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 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 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 Sponsor Phase Summary

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Clinical Trial Conditions for Umeclidinium Bromide

Condition Name

Condition Name for Umeclidinium Bromide
Intervention Trials
Pulmonary Disease, Chronic Obstructive 13
Asthma 3
Chronic Obstructive Pulmonary Disease (COPD) 2
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Condition MeSH

Condition MeSH for Umeclidinium Bromide
Intervention Trials
Pulmonary Disease, Chronic Obstructive 15
Lung Diseases 15
Chronic Disease 13
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Clinical Trial Locations for Umeclidinium Bromide

Trials by Country

Trials by Country for Umeclidinium Bromide
Location Trials
United States 147
Germany 80
China 26
Canada 21
United Kingdom 17
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Trials by US State

Trials by US State for Umeclidinium Bromide
Location Trials
Florida 9
South Carolina 9
California 8
North Carolina 8
Alabama 7
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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 1
Phase 3 13
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Umeclidinium Bromide
Clinical Trial Phase Trials
Completed 10
Recruiting 5
Active, not recruiting 2
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Clinical Trial Sponsors for Umeclidinium Bromide

Sponsor Name

Sponsor Name for Umeclidinium Bromide
Sponsor Trials
GlaxoSmithKline 16
Novartis Pharmaceuticals 2
York Bioanalytical Solution 1
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Sponsor Type

Sponsor Type for Umeclidinium Bromide
Sponsor Trials
Industry 19
Other 4
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