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Generated: February 20, 2019

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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.
NCT01822899 A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Completed GlaxoSmithKline Phase 3 This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with Chronic Obstructive Pulmonary Disease (COPD). Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 500/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.
NCT01899638 Pharmacokinetics Of Umeclidinium and Vilanterol in Healthy Chinese, a Randomized, Open Label, 3 Crossover Study. Completed GlaxoSmithKline Phase 1 This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.
NCT01957163 Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Completed GlaxoSmithKline Phase 3 After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.
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
Lung Diseases 15
Pulmonary Disease, Chronic Obstructive 15
Chronic Disease 13
Lung Diseases, Obstructive 8
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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
North Carolina 8
California 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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