A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD

NCT01313637 | Completed Phase 3 Results

• 2 other identifiers: 1133612010-023348-33
• Study Type: interventional
• Target: 1,493
• Locations: 14 countries
• Sites: 157

Brief Summary

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

anticholinergic; long-acting beta agonist

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)

  FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.

  Baseline and Day 169

Secondary Outcomes (2)

• Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)

  Day 168 (Week 24)

• Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168

  Baseline and Day 168

Other Outcomes (1)

• Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24

  Baseline and Week 24

Study Arms (4)

GSK573719/GW642444

EXPERIMENTAL

125/25mcg

Drug: GSK573719/GW642444 125/25mcg

GSK573719

EXPERIMENTAL

125mcg

Drug: GSK573719 125mcg

GW642444

EXPERIMENTAL

25mcg

Drug: GW642444 25mcg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo only

Interventions

GSK573719/GW642444 125/25mcg DRUG

125/25mcg

Also known as: umeclidinium bromide/vilanterol trifenatate

GSK573719/GW642444

GSK573719 125mcg DRUG

125mcg

Also known as: umeclidinium bromide

GSK573719

GW642444 25mcg DRUG

25mcg

Also known as: vilanterol trifenatate

GW642444

Placebo only DRUG

Placebo

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD
• pack-year or greater history of cigarette smoking
• Post-bronchodilator FEV1/FVC of \<0.7
• Predicted FEV1 of 70% of normal or less
• Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

You may not qualify if:

• Women who are pregnant, lactating, or planning to become pregnant
• Respiratory disorders other than COPD, including a current diagnosis of asthma
• Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled
• Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device
• Hospitalization for COPD or pneumonia within 12 weeks prior to screening
• Lung volume reduction surgery within 12 weeks prior to screening
• Abnormal and clinically significant ECG findings at screening
• Clinically significant laboratory findings at screening
• Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (\>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
• Use of long-term oxygen therapy (12 hours or greater per day)
• Regular use of nebulized treatment with short-acting bronchodilators
• Participation in the acute phase of a pulmonary rehabilitation program
• A know or suspected history of alcohol or drug abuse
• Affiliation with the investigational site
• Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW642444

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (157)

GSK Investigational Site

Jasper, Alabama, 35501, United States

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GSK Investigational Site

Phoenix, Arizona, 85006, United States

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GSK Investigational Site

Long Beach, California, 90822, United States

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GSK Investigational Site

Los Angeles, California, 90095, United States

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Palo Alto, California, 94304, United States

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GSK Investigational Site

Riverside, California, 92506, United States

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San Diego, California, 92103-8415, United States

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San Diego, California, 92117, United States

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Torrance, California, 90502, United States

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Clearwater, Florida, 33765, United States

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GSK Investigational Site

DeLand, Florida, 32720, United States

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GSK Investigational Site

Orlando, Florida, 32822, United States

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GSK Investigational Site

Panama City, Florida, 32405, United States

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GSK Investigational Site

Topeka, Kansas, 66606, United States

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Livonia, Michigan, 48152, United States

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Plymouth, Minnesota, 55441, United States

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Lincoln, Nebraska, 68506, United States

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GSK Investigational Site

Cherry Hill, New Jersey, 08003, United States

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Charlotte, North Carolina, 28207, United States

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Easley, South Carolina, 29640, United States

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Greenville, South Carolina, 29615, United States

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Spartanburg, South Carolina, 29303, United States

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GSK Investigational Site

Union, South Carolina, 29379, United States

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Richmond, Virginia, 23225, United States

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GSK Investigational Site

Aalst, 9300, Belgium

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Edegem, 2650, Belgium

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Genk, 3600, Belgium

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Kortrijk, 8500, Belgium

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Liège, 4000, Belgium

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Aalborg, 9100, Denmark

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Copenhagen, 2400, Denmark

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Hvidovre, 2650, Denmark

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Næstved, 4700, Denmark

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Odense C, 5000, Denmark

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Roedovre, 2610, Denmark

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Roskilde, 4000, Denmark

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Haapsalu, 90502, Estonia

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Pärnu, 80010, Estonia

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Rakvere, 44316, Estonia

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Tallinn, 10117, Estonia

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Tallinn, 10138, Estonia

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GSK Investigational Site

Tartu, 51014, Estonia

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Lyon, 69317, France

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Montauban, 82017, France

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Nice, 06000, France

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Perpignan, 66000, France

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Reims, 51092, France

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Tarbes, 65013, France

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Toulon, 83000, France

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Toulouse, 31059, France

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GSK Investigational Site

Tours, 37044, France

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GSK Investigational Site

Vieux-Condé, 59690, France

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Dillingen an der Donau, Bavaria, 89407, Germany

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Künzing, Bavaria, 94550, Germany

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Munich, Bavaria, 80809, Germany

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Schwabach, Bavaria, 91126, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Gelnhausen, Hesse, 63571, Germany

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Neu-Isenburg, Hesse, 63263, Germany

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Rodgau, Hesse, 63110, Germany

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Cologne, North Rhine-Westphalia, 51069, Germany

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Dresden, Saxony, 01307, Germany

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Leipzg, Saxony, 04109, Germany

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Leipzig, Saxony, 04103, Germany

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Magdeburg, Saxony-Anhalt, 39112, Germany

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Geesthacht, Schleswig-Holstein, 21502, Germany

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Schmölln, Thuringia, 04626, Germany

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Berlin, 10117, Germany

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Berlin, 10367, Germany

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Berlin, 10787, Germany

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Berlin, 13125, Germany

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Berlin, 13581, Germany

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Berlin, 14059, Germany

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Hamburg, 20246, Germany

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Hamburg, 20253, Germany

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Hamburg, 22143, Germany

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GSK Investigational Site

Balassagyarmat, 2660, Hungary

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Budapest, 1529, Hungary

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Debrecen, 4032, Hungary

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Deszk, 6772, Hungary

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Farkasgyepű, 8582, Hungary

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Gödöllő, 2100, Hungary

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Gyöngyös, 3200, Hungary

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Nyíregyháza, 4400, Hungary

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Sátoraljaújhely, 3980, Hungary

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Szikszó, 3800, Hungary

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Szombathely, 9700, Hungary

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Törökbálint, 2045, Hungary

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GSK Investigational Site

Aichi, 454-8502, Japan

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Aichi, 455-8530, Japan

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Aichi, 457-8510, Japan

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Chiba, 296-8602, Japan

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Fukuoka, 802-0052, Japan

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Fukuoka, 811-3195, Japan

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Fukuoka, 814-0180, Japan

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Fukuoka, 832-0059, Japan

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Hokkaido, 070-8644, Japan

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Ibaraki, 319-1113, Japan

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Kanagawa, 252-0001, Japan

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Miyagi, 989-1253, Japan

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Okayama, 714-0081, Japan

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Osaka, 596-8501, Japan

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Shizuoka, 434-8511, Japan

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Tokyo, 171-0014, Japan

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Tokyo, 194-0023, Japan

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Tokyo, 204-8585, Japan

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Alkmaar, 1815 JD, Netherlands

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Almelo, 7609 PP, Netherlands

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Almere Stad, 1311 RL, Netherlands

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Beek, 6191 JW, Netherlands

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Ede, 6716 RP, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Enschede, 7513 ER, Netherlands

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Groningen, 9728 NP, Netherlands

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Helmond, 5707 HA, Netherlands

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Hoorn, 1624 NP, Netherlands

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Tubbergen, 7651 JH, Netherlands

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Veldhoven, 5504 DB, Netherlands

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Zutphen, 7207 AE, Netherlands

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Bekkestua, 1319, Norway

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Bergen, 5017, Norway

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Bodø, 8005, Norway

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Elverum, 2408, Norway

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Kløfta, 2040, Norway

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Skedsmokorset, N-2020, Norway

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Stavanger, 4005, Norway

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Trondheim, 7011, Norway

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Trondheim, 7027, Norway

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Cebu City, 6000, Philippines

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Dasmariñas, Cavite, 4114, Philippines

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Marikina City, 1800, Philippines

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Marilao, Bulacan, 3019, Philippines

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Quezon City, 1109, Philippines

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Bardejov, 085 01, Slovakia

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Humenné, 066 01, Slovakia

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GSK Investigational Site

Poprad, 058 01, Slovakia

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GSK Investigational Site

Revúca, 050 01, Slovakia

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GSK Investigational Site

Spišská Nová Ves, 052 01, Slovakia

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Vráble, 952 01, Slovakia

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Gothenburg, SE-412 63, Sweden

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Gothenburg, SE-413 45, Sweden

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Höllviken, SE-236 32, Sweden

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Linköping, SE-582 16, Sweden

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Luleå, SE-971 89, Sweden

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Lund, SE-221 85, Sweden

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GSK Investigational Site

Malmo, SE-211 52, Sweden

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GSK Investigational Site

Stockholm, SE-111 57, Sweden

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Stockholm, SE-113 61, Sweden

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GSK Investigational Site

Vällingby, SE-162 68, Sweden

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Donetsk, 83099, Ukraine

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GSK Investigational Site

Ivano-Frankivsk, 76018, Ukraine

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GSK Investigational Site

Kharkiv, 61037, Ukraine

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GSK Investigational Site

Kharkiv, 61124, Ukraine

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GSK Investigational Site

Kiev, 03680, Ukraine

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GSK Investigational Site

Kyiv, 03680, Ukraine

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Simferopol, 95043, Ukraine

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GSK Investigational Site

Zaporizhia, 69035, Ukraine

Location

Related Publications (1)

• Celli B, Crater G, Kilbride S, Mehta R, Tabberer M, Kalberg CJ, Church A. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest. 2014 May;145(5):981-991. doi: 10.1378/chest.13-1579.

  PMID: 24385182 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK573719; fluticasone furoate-vilanterol trifenatate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 14, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 19, 2012
• Last Updated: January 29, 2018
• Results First Posted: February 10, 2014

Record last verified: 2018-01

Locations

US (24); ES (6); UA (8); DK (7); BE (5); HU (12); NO (9); DE (24); FR (10); JP (18); NL (13); PH (5); SL (6); SE (10)