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Last Updated: October 7, 2024

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.
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 2013-04-04 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 2013-05-20 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 2013-10-01 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 >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
Chronic Obstructive Pulmonary Disease (COPD) 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
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 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
South Carolina 10
North 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
Withdrawn 1
Not yet recruiting 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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