A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD

NCT01313650 | Completed Phase 3 Results

• 2 other identifiers: 1133732010-023349-32
• Study Type: interventional
• Target: 1,538
• Locations: 13 countries
• Sites: 165

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

long-acting beta agonist; anticholinergic

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

62.5/25mcg

Drug: 62.5/25mcg

GSK573719

EXPERIMENTAL

62.5mcg

Drug: 62.5mcg

GW642444

EXPERIMENTAL

25mcg

Drug: 25mcg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

62.5/25mcg DRUG

GSK573719/GW64244

GSK573719/GW642444

62.5mcg DRUG

GSK573719

GSK573719

25mcg DRUG

GW642444

GW642444

Placebo DRUG

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 adequate controlled
• Significant allergy or hypersensitivity to anticholinergics, beta-agonist, 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 GW64244

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (165)

GSK Investigational Site

Tucson, Arizona, 85723, United States

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GSK Investigational Site

Los Angeles, California, 90048, United States

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GSK Investigational Site

Ormond Beach, Florida, 32174, United States

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GSK Investigational Site

Tampa, Florida, 33603, United States

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GSK Investigational Site

Atlanta, Georgia, 30342, United States

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GSK Investigational Site

Lawrenceville, Georgia, 30046, United States

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GSK Investigational Site

Coeur d'Alene, Idaho, 83814, United States

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GSK Investigational Site

Lafayette, Indiana, 47904, United States

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GSK Investigational Site

Olathe, Kansas, 66061, United States

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GSK Investigational Site

Topeka, Kansas, 66606, United States

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GSK Investigational Site

Madisonville, Kentucky, 42431, United States

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GSK Investigational Site

New Orleans, Louisiana, 70115, United States

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GSK Investigational Site

Sunset, Louisiana, 70584, United States

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GSK Investigational Site

Cadillac, Michigan, 49601, United States

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GSK Investigational Site

St Louis, Missouri, 63141, United States

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GSK Investigational Site

Omaha, Nebraska, 68134, United States

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GSK Investigational Site

Albuquerque, New Mexico, 87108, United States

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GSK Investigational Site

Larchmont, New York, 10538, United States

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GSK Investigational Site

Cincinnati, Ohio, 45231, United States

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GSK Investigational Site

Cincinnati, Ohio, 45245, United States

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GSK Investigational Site

Columbus, Ohio, 43215, United States

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GSK Investigational Site

Dayton, Ohio, 45459, United States

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GSK Investigational Site

Medford, Oregon, 97504, United States

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GSK Investigational Site

Beaver, Pennsylvania, 15009, United States

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GSK Investigational Site

Erie, Pennsylvania, 16508, United States

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GSK Investigational Site

Phoenixville, Pennsylvania, 19460, United States

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GSK Investigational Site

Gaffney, South Carolina, 29340, United States

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GSK Investigational Site

Greenville, South Carolina, 29615, United States

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GSK Investigational Site

Pelzer, South Carolina, 29669, United States

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GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

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GSK Investigational Site

Rapid City, South Dakota, 57702, United States

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GSK Investigational Site

Johnson City, Tennessee, 37601, United States

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GSK Investigational Site

Houston, Texas, 77030, United States

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GSK Investigational Site

Kingwood, Texas, 77339, United States

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GSK Investigational Site

Abingdon, Virginia, 24210, United States

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GSK Investigational Site

Newport News, Virginia, 23606, United States

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GSK Investigational Site

Richmond, Virginia, 23249, United States

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GSK Investigational Site

Dimitrovgrad, 6400, Bulgaria

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GSK Investigational Site

Pleven, 5800, Bulgaria

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GSK Investigational Site

Plovdiv, 4000, Bulgaria

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GSK Investigational Site

Rousse, 7000, Bulgaria

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GSK Investigational Site

Sofia, 1000, Bulgaria

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GSK Investigational Site

Sofia, 1202, Bulgaria

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GSK Investigational Site

Sofia, 1431, Bulgaria

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GSK Investigational Site

Sofia, Bulgaria

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GSK Investigational Site

Troyan Municipality, 5600, Bulgaria

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GSK Investigational Site

Varna, 9010, Bulgaria

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GSK Investigational Site

Calgary, Alberta, T2N 4Z6, Canada

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Winnipeg, Manitoba, R2K 3S8, Canada

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GSK Investigational Site

Burlington, Ontario, L7N 3V2, Canada

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Grimsby, Ontario, L3M 1P3, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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GSK Investigational Site

Toronto, Ontario, M3H 5S4, Canada

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Toronto, Ontario, M5G 1N8, Canada

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Toronto, Ontario, M9W 4L6, Canada

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GSK Investigational Site

Montreal, Quebec, H2R 1V6, Canada

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GSK Investigational Site

Pointe-Claire, Quebec, H9R 3J1, Canada

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GSK Investigational Site

Québec, Quebec, G1V 4G5, Canada

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GSK Investigational Site

Québec, Quebec, G3K 2P8, Canada

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GSK Investigational Site

Saint-Charles-Borromée, Quebec, J6E 6J2, Canada

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GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

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GSK Investigational Site

Rancagua, Reg Del Libert Bern Ohiggins, 2841959, Chile

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GSK Investigational Site

Valparaíso, Región de Valparaíso, 2341131, Chile

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GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, 8880465, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

Talcahuano, 4270918, Chile

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GSK Investigational Site

Viña del Mar, 2570017, Chile

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GSK Investigational Site

Český Krumlov, 381 01, Czechia

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GSK Investigational Site

Kralupy nad Vltavou, 278 01, Czechia

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GSK Investigational Site

Kyjov, 697 33, Czechia

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GSK Investigational Site

Lovosice, 410 02, Czechia

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GSK Investigational Site

Nový Jičín, 741 01, Czechia

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GSK Investigational Site

Olomouc, 772 00, Czechia

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GSK Investigational Site

Pilsen, 301 00, Czechia

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GSK Investigational Site

Prague, 150 00, Czechia

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GSK Investigational Site

Praha 5 - Radotin, 153 00, Czechia

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GSK Investigational Site

Rokycany, 337 01, Czechia

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GSK Investigational Site

Teplice, 415 10, Czechia

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GSK Investigational Site

Athens, 106 76, Greece

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GSK Investigational Site

Athens, 115 27, Greece

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GSK Investigational Site

Athens, 151 26, Greece

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GSK Investigational Site

Haidari / Athens, 124 62, Greece

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GSK Investigational Site

Heraklion, Crete, 71110, Greece

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GSK Investigational Site

Larissa, 41110, Greece

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GSK Investigational Site

Serres, 62100, Greece

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GSK Investigational Site

Thessaloniki, 546 42, Greece

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GSK Investigational Site

Thessaloniki, 56429, Greece

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GSK Investigational Site

Fukushima, 963-8052, Japan

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GSK Investigational Site

Hyōgo, 672-8064, Japan

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GSK Investigational Site

Ibaraki, 311-3193, Japan

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GSK Investigational Site

Ibaraki, 312-0057, Japan

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GSK Investigational Site

Kanagawa, 254-8502, Japan

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GSK Investigational Site

Kumamoto, 861-1196, Japan

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GSK Investigational Site

Kyoto, 602-8026, Japan

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GSK Investigational Site

Osaka, 530-0001, Japan

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GSK Investigational Site

Osaka, 558-8558, Japan

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GSK Investigational Site

Saitama, 343-8555, Japan

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GSK Investigational Site

Shimane, 690-8506, Japan

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GSK Investigational Site

Shimane, 690-8556, Japan

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GSK Investigational Site

Tokyo, 103-0027, Japan

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GSK Investigational Site

Tokyo, 103-0028, Japan

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GSK Investigational Site

Tokyo, 158-0083, Japan

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GSK Investigational Site

Tokyo, 173-8610, Japan

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GSK Investigational Site

Guadalajara, Jalisco, 44100, Mexico

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GSK Investigational Site

Zapopan, Jalisco, 45040, Mexico

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GSK Investigational Site

Monterrey, Nuevo León, 64020, Mexico

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GSK Investigational Site

Puebla, Pue, Puebla, 72000, Mexico

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GSK Investigational Site

Bydgoszcz, 85-681, Poland

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GSK Investigational Site

Gidle, 97-540, Poland

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GSK Investigational Site

Grudziądz, 86-300, Poland

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GSK Investigational Site

Iława, 14-200, Poland

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GSK Investigational Site

Krakow, 31-023, Poland

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GSK Investigational Site

Olsztyn, 10-357, Poland

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GSK Investigational Site

Poznan, 60-569, Poland

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GSK Investigational Site

Szczecin, 71-124, Poland

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GSK Investigational Site

Warsaw, 01-456, Poland

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GSK Investigational Site

Łomża, 18-400, Poland

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GSK Investigational Site

Arkhangelsk, 153000, Russia

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GSK Investigational Site

Barnaul, 656 045, Russia

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GSK Investigational Site

Blagoveshchensk, 675000, Russia

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GSK Investigational Site

Krasnoyarsk, 660022, Russia

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GSK Investigational Site

Moscow, 105 229, Russia

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GSK Investigational Site

Moscow, 119620, Russia

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GSK Investigational Site

Moscow, 123182, Russia

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GSK Investigational Site

Nizhny Novgorod, 603126, Russia

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GSK Investigational Site

Novosibirsk, 630087, Russia

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GSK Investigational Site

Perm, 614077, Russia

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GSK Investigational Site

Pyatigorsk, 357538, Russia

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GSK Investigational Site

Saint Petersburg, 194354, Russia

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GSK Investigational Site

Saint Petersburg, 198260, Russia

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GSK Investigational Site

Saratov, 410028, Russia

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GSK Investigational Site

Tomsk, 634063, Russia

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GSK Investigational Site

Ufa, 450071, Russia

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GSK Investigational Site

Yaroslavl, 150062, Russia

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GSK Investigational Site

Benoni, Gauteng, 1501, South Africa

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GSK Investigational Site

Meyerspark, Gauteng, 0184, South Africa

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GSK Investigational Site

Bloemfontein, 9301, South Africa

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GSK Investigational Site

Durban, 4001, South Africa

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GSK Investigational Site

Gatesville, 7764, South Africa

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GSK Investigational Site

Mowbray, 7700, South Africa

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GSK Investigational Site

Newtown, 2113, South Africa

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GSK Investigational Site

Somerset West, 7130, South Africa

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GSK Investigational Site

Tygerberg, 7505, South Africa

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GSK Investigational Site

Alicante, 03114, Spain

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GSK Investigational Site

Badalona, 08916, Spain

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GSK Investigational Site

Badalona / Barcelona, Spain

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GSK Investigational Site

Barakaldo (Vizcaya), 48903, Spain

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GSK Investigational Site

Cáceres, 10003, Spain

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GSK Investigational Site

Centelles, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Palma de Mallorca, 07010, Spain

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GSK Investigational Site

Pamplona, 31008, Spain

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GSK Investigational Site

Pozuelo de Alarcón/Madrid, 28223, Spain

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GSK Investigational Site

Salt (gerona), 17190, Spain

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GSK Investigational Site

Sant Boi de Llobregat - Barcelona, 08830, Spain

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GSK Investigational Site

Santander, 38008, Spain

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GSK Investigational Site

Santiago de Compostela, 15706, Spain

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GSK Investigational Site

Valencia, 46015, Spain

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GSK Investigational Site

Bangkok, 10330, Thailand

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GSK Investigational Site

Bangkok, 10400, Thailand

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GSK Investigational Site

Chiang Mai, 50200, Thailand

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GSK Investigational Site

Khon Kaen, 40002, Thailand

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GSK Investigational Site

Nonthaburi, 11000, Thailand

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GSK Investigational Site

Songkhla, 90110, Thailand

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Related Publications (1)

• Donohue JF, Maleki-Yazdi MR, Kilbride S, Mehta R, Kalberg C, Church A. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013 Oct;107(10):1538-46. doi: 10.1016/j.rmed.2013.06.001. Epub 2013 Jul 2.

  PMID: 23830094 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

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: April 1, 2012
• Study Completion: April 5, 2012
• Last Updated: August 6, 2018
• Results First Posted: March 4, 2014

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

CZ (11); PL (10); BU (10); US (37); RU (17); ES (15); CL (7); ME (4); CA (14); GR (9); JP (16); ZA (9); TH (6)