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Search / Trial NCT02164513

A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Launched by GLAXOSMITHKLINE · Jun 12, 2014

Trial Information

Current as of May 28, 2025

Completed

Keywords

Copd Umeclidinium Fluticasone Furoate Vilanterol Triple Therapy Exacerbation

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Informed Consent: A signed and dated written informed consent prior to study participation
  • Type of subject: Outpatient
  • Age: Subjects 40 years of age or older at Visit 1
  • Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, \> 45 years, in the absence of hormone replacement therapy OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to safety follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS); Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
  • COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
  • Smoking History: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at screening (visit 1) \[number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history
  • Severity of COPD symptoms: A score of \>=10 on the COPD Assessment Test (CAT) at screening
  • Severity of COPD Disease: A post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of \<0.70 at Screening
  • Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Note: Subjects receiving only Pro re nata (PRN) COPD medications are not eligible
  • History of Exacerbations: Subjects must demonstrate: a post-bronchodilator FEV1 \<50% predicted normal and a documented history of \>= 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% \<=FEV1 \< 80% predicted normal and a documented history of \>= 2 moderate exacerbations or a documented history of \>=1 severe COPD exacerbation (hospitalized) in the previous 12 months. Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable
  • Liver function tests: alanine aminotransferase (ALT) \<2x upper limit of normal (ULN); alkaline phosphatase \<=1.5xULN; bilirubin \<=1.5xULN (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
  • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
  • Exclusion Criteria:
  • Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
  • Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
  • Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD
  • Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
  • Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
  • Risk Factors for Pneumonia: immune suppression (e.g. human immunodeficiency virus \[HIV\], Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator
  • Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded
  • Other Respiratory tract infections that have not resolved at least 7 days prior to screening
  • Abnormal Chest x-ray(CXR): Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1 (or historical radiograph or computerised tomography (CT) scan obtained within 3 months prior to screening) that will be over-read by a central vendor. Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation chest x-ray to be over-read by the central vendor or have a chest x-ray conducted at screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz \[BfS\])
  • Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
  • Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria
  • Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure
  • Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Principal Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: atrial fibrillation (AF) with rapid ventricular rate \>120 beats per minute); sustained or nonsustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate (QTcF) \>=500 milliseconds (msec) in patients with QRS \<120 msec and QTcF \>=530 msec in patients with QRS \>=120 msec
  • Contraindications: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator contraindicates study participation
  • Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment
  • Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy \>3 Liter/minute (L/min) (Oxygen use =\<3L/min flow is not exclusionary)
  • Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit
  • Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded
  • Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
  • Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits
  • Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
  • Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or study site, or immediate family members of the aforementioned that is involved with this study
  • Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials
  • Medication prior to screening: Use of the following medications within the following time intervals prior to Screening (Visit 1) or during the study: Long term antibiotic therapy Subjects receiving antibiotics for long term therapy are not eligible for the study (Antibiotics are allowed for the short term treatment of an exacerbation or for short term treatment of other acute infections during the study); Systemic, Oral, parenteral corticosteroids 30 days (Except during the study oral/systemic corticosteroids may be used to treat COPD exacerbations/pneumonia) Intra-articular injections are allowed; Any other investigational drug (30 days or 5 half lives whichever is longer)

About Glaxosmithkline

GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.

Locations

Decatur, Georgia, United States

New Orleans, Louisiana, United States

Bronx, New York, United States

Fort Worth, Texas, United States

Barcelona, , Spain

Sevilla, , Spain

Shreveport, Louisiana, United States

Saint Louis, Missouri, United States

Syracuse, New York, United States

Houston, Texas, United States

Asheville, North Carolina, United States

Charlotte, North Carolina, United States

Canton, Ohio, United States

Spartanburg, South Carolina, United States

Tacoma, Washington, United States

Valparaiso, Valparaíso, Chile

Hampton, Virginia, United States

Durham, North Carolina, United States

Adelaide, South Australia, Australia

Gauting, Bayern, Germany

Ramat Gan, , Israel

Leeuwarden, , Netherlands

Quezon City, , Philippines

Pittsburgh, Pennsylvania, United States

Marietta, Georgia, United States

Albany, New York, United States

Philadelphia, Pennsylvania, United States

Lynchburg, Virginia, United States

Santa Ana, California, United States

Mobile, Alabama, United States

Santa Monica, California, United States

Torrance, California, United States

Upland, California, United States

New Port Richey, Florida, United States

Woodstock, Georgia, United States

Coeur D'alene, Idaho, United States

Evansville, Indiana, United States

Ann Arbor, Michigan, United States

Edina, Minnesota, United States

Rochester, Minnesota, United States

Jackson, Mississippi, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Marlton, New Jersey, United States

Greensboro, North Carolina, United States

Winston Salem, North Carolina, United States

Marion, Ohio, United States

Virginia Beach, Virginia, United States

Seattle, Washington, United States

Rosario, Santa Fe, Argentina

Westmead, New South Wales, Australia

Gent, , Belgium

Hasselt, , Belgium

Turnhout, , Belgium

Burlington, Ontario, Canada

Turku, , Finland

Nimes, , France

Dachau, Bayern, Germany

Nuernberg, Bayern, Germany

Rosenheim, Bayern, Germany

Koblenz, Rheinland Pfalz, Germany

Hettstedt, Sachsen Anhalt, Germany

Leipzig, Sachsen, Germany

Schleswig, Schleswig Holstein, Germany

Eindhoven, , Netherlands

Harderwijk, , Netherlands

Nieuwegein, , Netherlands

Ponce, , Puerto Rico

Madrid, , Spain

Oviedo, , Spain

Pamplona, , Spain

San Juan De Alicante, , Spain

Valladolid, , Spain

Exeter, Devon, United Kingdom

Albuquerque, New Mexico, United States

Maitland, Florida, United States

Iowa City, Iowa, United States

Truro, Nova Scotia, Canada

Footscray, Victoria, Australia

Glendale, Arizona, United States

Encinitas, California, United States

Golden, Colorado, United States

O'fallon, Illinois, United States

Renton, Washington, United States

Sarasota, Florida, United States

Bangor, Maine, United States

Augsburg, Bayern, Germany

Moorestown, New Jersey, United States

Elk Grove Village, Illinois, United States

Leesburg, Florida, United States

East Providence, Rhode Island, United States

Deland, Florida, United States

Lafayette, Louisiana, United States

Chesterfield, Missouri, United States

Gastonia, North Carolina, United States

Wilmington, North Carolina, United States

Anderson, South Carolina, United States

Johnson City, Tennessee, United States

Tucson, Arizona, United States

Chula Vista, California, United States

Newport Beach, California, United States

Colorado Springs, Colorado, United States

Austell, Georgia, United States

Cincinnati, Ohio, United States

Medford, Oregon, United States

Wyomissing, Pennsylvania, United States

Greenville, South Carolina, United States

Tomball, Texas, United States

Phoenix, Arizona, United States

Riverside, California, United States

Brandon, Florida, United States

Pensacola, Florida, United States

Tampa, Florida, United States

Topeka, Kansas, United States

Dayton, Ohio, United States

Kingwood, Texas, United States

Bellingham, Washington, United States

Jacksonville, Florida, United States

Downingtown, Pennsylvania, United States

Vienna, , Austria

Mannheim, Baden Wuerttemberg, Germany

Wallerfing, Bayern, Germany

Potsdam, Brandenburg, Germany

Koeln, Nordrhein Westfalen, Germany

Halberstadt, Sachsen Anhalt, Germany

Sabadell (Barcelona), , Spain

Jasper, Alabama, United States

Nedlands, Western Australia, Australia

Brugge, , Belgium

Zaragoza, , Spain

Bakersfield, California, United States

Fort Lauderdale, Florida, United States

Liège, , Belgium

Stamford, Connecticut, United States

Waterbury, Connecticut, United States

Bay Pines, Florida, United States

Chicago, Illinois, United States

Oak Park, Illinois, United States

Butte, Montana, United States

Corvallis, Oregon, United States

Genk, , Belgium

Winnipeg, Manitoba, Canada

Praha 5, , Czechia

Tampere, , Finland

Montpellier Cedex 5, , France

Pokfulam, , Hong Kong

Shatin, , Hong Kong

Afula, , Israel

Zrifin, , Israel

San Juan, , Puerto Rico

Ekaterinburg, , Russian Federation

La Coruña, , Spain

Bangkok, , Thailand

Chiangmai, , Thailand

Modesto, California, United States

Sacramento, California, United States

Winfield, Illinois, United States

Aalborg, , Denmark

Orléans Cedex 2, , France

Neu Ulm, Bayern, Germany

Holon, , Israel

Alkmaar, , Netherlands

Hoofddorp, , Netherlands

Veldhoven, , Netherlands

Santiago De Compostela, , Spain

Vizcaya, , Spain

Izmir, , Turkey

Northwood, Middlesex, United Kingdom

New Haven, Connecticut, United States

Huntersville, North Carolina, United States

Windsor, Ontario, Canada

Chattanooga, Tennessee, United States

San Antonio, Texas, United States

Concord, New South Wales, Australia

Göteborg, , Sweden

Worcester, Massachusetts, United States

Daw Park, South Australia, Australia

Vandoeuvre Les Nancy, , France

Kwun Tong, , Hong Kong

La Plata, Buenos Aires, Argentina

Novosibirsk, , Russian Federation

Khon Kaen, , Thailand

Muscle Shoals, Alabama, United States

Hartford, Connecticut, United States

Columbus, Georgia, United States

Sunset, Louisiana, United States

Elizabeth City, North Carolina, United States

Charleston, South Carolina, United States

Richmond, Virginia, United States

Huntington Beach, California, United States

Long Beach, California, United States

North Dartmouth, Massachusetts, United States

Corsicana, Texas, United States

Kerrville, Texas, United States

Vista, California, United States

Minneapolis, Minnesota, United States

Missoula, Montana, United States

Bronxville, New York, United States

Erie, Pennsylvania, United States

Gaffney, South Carolina, United States

Muncie, Indiana, United States

Seoul, , Korea, Republic Of

Girona, , Spain

Columbia, Maryland, United States

Doylestown, Pennsylvania, United States

Arcadia, California, United States

Nueve De Julio, Buenos Aires, Argentina

Santa Fe, , Argentina

Pessac Cedex, , France

Gatineau, Quebec, Canada

Mirabel, Quebec, Canada

Trebic, , Czechia

Deggingen, Baden Wuerttemberg, Germany

Mainz, Rheinland Pfalz, Germany

Birmingham, Alabama, United States

Danbury, Connecticut, United States

Port Orange, Florida, United States

Fall River, Massachusetts, United States

Ciudad Autónoma De Buenos Aires, , Argentina

Odense C, , Denmark

Muenchen, Bayern, Germany

Saarbruecken, Saarland, Germany

Delitzsch, Sachsen, Germany

Levanger, , Norway

Saratov, , Russian Federation

Yaroslavl, , Russian Federation

Durban, , South Africa

Mérida (Badajoz), , Spain

Kharkiv, , Ukraine

Olathe, Kansas, United States

Abingdon, Virginia, United States

Trois Rivieres, Quebec, Canada

Breda, , Netherlands

Tabor, , Czechia

Geesthacht, Schleswig Holstein, Germany

Mount Pleasant, South Carolina, United States

Plzen, , Czechia

Clearwater, Florida, United States

Jyvaskyla, , Finland

Berlin, , Germany

L'hospitalet De Llobregat, , Spain

Hamilton, Ontario, Canada

Frankfurt, Hessen, Germany

Gelsenkirchen, Nordrhein Westfalen, Germany

Songkla, , Thailand

Mendoza, , Argentina

Loxahatchee Groves, Florida, United States

Nanning, Guangxi, China

Dordrecht, , Netherlands

Helmond, , Netherlands

Hellerup, , Denmark

Bogota, , Colombia

Paris, , France

Tustin, California, United States

Everett, Washington, United States

Carina Heights, Queensland, Australia

Sudbury, Ontario, Canada

Rolling Hills Estates, California, United States

Hoorn, , Netherlands

Zwolle, , Netherlands

Pembroke Pines, Florida, United States

Katy, Texas, United States

Fridley, Minnesota, United States

Bucharest, , Romania

Assen, , Netherlands

Plano, Texas, United States

Stockholm, , Sweden

Santander, , Spain

Spijkenisse, , Netherlands

Clayton, Victoria, Australia

Geelong, Victoria, Australia

Tel Aviv, , Israel

Rehovot, , Israel

Jinan, Shandong, China

Tuen Mun, , Hong Kong

Hvidovre, , Denmark

Saint Charles, Missouri, United States

Bad Woerrishofen, Bayern, Germany

Landsberg, Bayern, Germany

Ruedersdorf, Brandenburg, Germany

Bonn, Nordrhein Westfalen, Germany

Dueren, Nordrhein Westfalen, Germany

Rotterdam, , Netherlands

San Diego, California, United States

Frankston, Victoria, Australia

Oostende, , Belgium

Chongqing, , China

Shanghai, , China

Helsinki, , Finland

Lohja, , Finland

Hannover, Niedersachsen, Germany

Lai Chi Kok, , Hong Kong

Mowbray, , South Africa

Kiev, , Ukraine

Brest Cedex, , France

Gillespie, Illinois, United States

Sarnia, Ontario, Canada

Le Mans, , France

Aschaffenburg, Bayern, Germany

Offenbach, Hessen, Germany

Warendorf, Nordrhein Westfalen, Germany

Basurto/Bilbao, , Spain

Sagunto/Valencia, , Spain

Troy, Michigan, United States

Tabor City, North Carolina, United States

Kassel, Hessen, Germany

Neuss, Nordrhein Westfalen, Germany

Bradford, , United Kingdom

Lewisville, Texas, United States

Sheffield, Alabama, United States

Chengdu, Sichuan, China

Bloemfontein, , South Africa

Fredrikstad, , Norway

Valencia, , Spain

Leipzg, Sachsen, Germany

Longview, Texas, United States

Sugar Land, Texas, United States

Jerusalem, , Israel

Toulon, , France

Wiesloch, Baden Wuerttemberg, Germany

Puente Alto Santiago, Región Metro De Santiago, Chile

Aichi, , Japan

Burgos, , Spain

Xian, Shanxi, China

Tianjin, , China

Krasnoyarsk, , Russian Federation

Sioux Falls, South Dakota, United States

Neuwied, Rheinland Pfalz, Germany

Gainesville, Florida, United States

Marburg, Hessen, Germany

Luleå, , Sweden

Mission Hills, California, United States

Cottbus, Brandenburg, Germany

Port Charlotte, Florida, United States

Southfield, Michigan, United States

Pittsfield, Massachusetts, United States

Panorama, , South Africa

Rio De Janeiro, , Brazil

Roskilde, , Denmark

Witten, Nordrhein Westfalen, Germany

Ashkelon, , Israel

Haifa, , Israel

Cáceres, , Spain

Antwerpen, , Belgium

Kolding, , Denmark

Kansas City, Missouri, United States

Wellington, , New Zealand

Paducah, Kentucky, United States

Rennes Cedex 9, , France

Woodbury, Minnesota, United States

Amanzimtoti, , South Africa

Bellville, , South Africa

Portland, Oregon, United States

Tygerberg, , South Africa

Ruesselsheim, Hessen, Germany

Perpignan, , France

Dortmund, Nordrhein Westfalen, Germany

Fuzhou, , China

Fremont, Nebraska, United States

Mooresville, North Carolina, United States

Barnaul, , Russian Federation

Voronezh, , Russian Federation

Gilly, , Belgium

Palo Alto, California, United States

Grand Island, Nebraska, United States

Málaga, , Spain

San Sebastian De Los Reyes, , Spain

Tomsk, , Russian Federation

Rodgau, Hessen, Germany

Hamburg, , Germany

Oviedo, Florida, United States

Toledo, Ohio, United States

Nanjing, Jiangsu, China

Schmoelln, Thueringen, Germany

Cairns, Queensland, Australia

Daytona Beach, Florida, United States

Rapid City, South Dakota, United States

Wishaw, Lanarkshire, United Kingdom

Boulder, Colorado, United States

Florence, Alabama, United States

Union, South Carolina, United States

Vicente Lopez, Buenos Aires, Argentina

Bialystok, , Poland

Brussels, , Belgium

Mar Del Plata, Buenos Aires, Argentina

Solingen, Nordrhein Westfalen, Germany

Salamanca, , Spain

Barranquilla, , Colombia

Medellin, , Colombia

Grenoble Cedex 9, , France

Kanagawa, , Japan

Stavanger, , Norway

Sopot, , Poland

Hradec Kralove, , Czechia

Ponte Vedra Beach, Florida, United States

Conyers, Georgia, United States

Franklin, Indiana, United States

Greenfield, Indiana, United States

Middleburg Heights, Ohio, United States

Gosford, New South Wales, Australia

Roeselaere, , Belgium

Guangzhou, Guangdong, China

Strasbourg Cedex, , France

Enschede, , Netherlands

Paarl, , South Africa

Pozuelo De Alarcón/Madrid, , Spain

östersund, , Sweden

Odesa, , Ukraine

Kyoto, , Japan

Calabash, North Carolina, United States

Shelby, North Carolina, United States

Tipton, Pennsylvania, United States

Lima, , Peru

Edgewater, Florida, United States

Fort Mitchell, Kentucky, United States

Alzira/Valencia, , Spain

Pringy Cedex, , France

Zerbst, Sachsen Anhalt, Germany

Bodø, , Norway

Kløfta, , Norway

Kazan, , Russian Federation

Bayonne Cedex, , France

Easley, South Carolina, United States

Seneca, South Carolina, United States

Lyon Cedex 04, , France

örebro, , Sweden

Aarhus C, , Denmark

Ostrava Poruba, , Czechia

Ibaraki, , Japan

Nagano, , Japan

Talcahuano, , Chile

Zgierz, , Poland

Saint Petersburg, , Russian Federation

Mykolayiv, , Ukraine

Shijiazhuang, Hebei, China

Shenyang, Liaoning, China

Beijing, , China

Hyogo, , Japan

Kangwon Do, , Korea, Republic Of

Groningen, , Netherlands

Sneek, , Netherlands

San Martin De Porres, Lima, Peru

Nakhon Ratchasima, , Thailand

Peoria, Arizona, United States

Quebec, , Canada

Boksburg North, , South Africa

High Heaton, Newcastle Upon Tyne, Tyne & Wear, United Kingdom

Middelburg, Mpumalanga, South Africa

Council Bluffs, Iowa, United States

Lincoln, Nebraska, United States

Beek, , Netherlands

Zutphen, , Netherlands

San Miguel, Lima, Peru

Gatesville, , South Africa

Bradford On Avon, Wiltshire, United Kingdom

Cambridge, , United Kingdom

Benesov, , Czechia

Petrer/Alicante, , Spain

Reinfeld, Schleswig Holstein, Germany

Pyatigorsk, , Russian Federation

San Miguel De Tucumán, , Argentina

Praha 8, , Czechia

Ehime, , Japan

Osaka, , Japan

Szczecin, , Poland

Constanta, , Romania

Ivanovo, , Russian Federation

Fukuoka, , Japan

Blagoveshchensk, , Russian Federation

Volgodonsk, , Russian Federation

Wichita, Kansas, United States

Fort Mill, South Carolina, United States

Bahía Blanca, Buenos Aires, Argentina

Concepcion Del Uruguay, Entre Ríos, Argentina

Buenos Aires, , Argentina

Ankara, , Turkey

Ishikawa, , Japan

Tokyo, , Japan

Kyiv, , Ukraine

Maroubra, New South Wales, Australia

La Roca Del Valles (Barcelona), , Spain

Peralada( Girona), , Spain

Borås, , Sweden

Hokkaido, , Japan

Miyagi, , Japan

Oita, , Japan

Okayama, , Japan

Yamanashi, , Japan

Gera, Thueringen, Germany

Stuttgart, Baden Wuerttemberg, Germany

Belgorod, , Russian Federation

Neptune, New Jersey, United States

Escondido, California, United States

Haikou, Hainan, China

Nanchang, Jiangxi, China

Changchun, Jilin, China

Coslada, , Spain

Montauban Cedex, , France

Dillingen, Bayern, Germany

Trondheim, , Norway

Höllviken, , Sweden

Phoenixville, Pennsylvania, United States

Olomouc, , Czechia

Teplice, , Czechia

Kumamoto, , Japan

Benoni, Gauteng, South Africa

Athens, Alabama, United States

Flagstaff, Arizona, United States

Fort Collins, Colorado, United States

Celebration, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Saint Petersburg, Florida, United States

Rincon, Georgia, United States

Quincy, Illinois, United States

Saint Paul, Minnesota, United States

New York, New York, United States

Wooster, Ohio, United States

Rock Hill, South Carolina, United States

Edinburg, Texas, United States

Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina

Cordoba, Córdova, Argentina

Coronel Suarez, , Argentina

Monte Grande, , Argentina

Salta, , Argentina

Feldbach, , Austria

Feldkirch, , Austria

Grieskirchen, , Austria

Thalheim Bei Wels, , Austria

Erpent, , Belgium

Zhanjiang, Guangdong, China

Yinchuan, Ningxia, China

Taiyuan, Shanxi, China

Wuxi, , China

Bogotá, , Colombia

Holesov, , Czechia

Jaromer, , Czechia

Bensheim, Hessen, Germany

Wardenburg, Niedersachsen, Germany

Bergisch Gladbach, Nordrhein Westfalen, Germany

Hagen, Nordrhein Westfalen, Germany

Gifu, , Japan

Gyeonggi Do, , Korea, Republic Of

Incheon, , Korea, Republic Of

Iloilo, , Philippines

Jaro, Iloilo City, , Philippines

Pasig, , Philippines

Ostrowiec Swietokrzyski, , Poland

Brasov, , Romania

Ploiesti, , Romania

Ramnicu Valcea, , Romania

Moscow, , Russian Federation

Ryazan, , Russian Federation

St. Petersburg, , Russian Federation

Ulyanovsk, , Russian Federation

Boksburg, Gauteng, South Africa

Pretoria, Gauteng, South Africa

Capetown, , South Africa

Korsten, , South Africa

Mataró, , Spain

Muang, , Thailand

Istanbul, , Turkey

Sumy, , Ukraine

Sidcup, Kent, , United Kingdom

Ha Noi, , Vietnam

Ho Chi Minh, , Vietnam

Novgorod, , Russian Federation

Bamberg, Bayern, Germany

Chita, , Russian Federation

Petrozavodsk, , Russian Federation

Petah Tikva, , Israel

Ponferrada (León), , Spain

Duluth, Georgia, United States

Nan, , Thailand

Changsha, , China

Teuchern, Sachsen Anhalt, Germany

Mechelen, , Belgium

Centelles (Barcelona), , Spain

Sealy, Texas, United States

Bad Lippspringe, Nordrhein Westfalen, Germany

San Miguel De Tucuman, Tucumán, Argentina

Montigny Le Tilleul, , Belgium

Rathenow, Brandenburg, Germany

Frankenberg, Hessen, Germany

Ratingen, Nordrhein Westfalen, Germany

Auerbach, Sachsen, Germany

Lleida, , Spain

Qingdao, Shandong, China

Rheine, Nordrhein Westfalen, Germany

Kloosterhaar, , Netherlands

Neu Isenburg, Hessen, Germany

Berazategui, , Argentina

St Charles Borromée, Quebec, Canada

Jeonju Si, , Korea, Republic Of

Alicante, , Spain

Liverpool, , Australia

San Rafael, Mendoza, Argentina

Hangzhou, Zhejiang, China

Braila, , Romania

Vladivostok, , Russian Federation

Kagawa, , Japan

Concepción, Región Del Biobio, Chile

Viña Del Mar, Valparaíso, Chile

Krasnodar, , Russian Federation

Cvikov, , Czechia

Edmonton, Alberta, Canada

Kfar Saba, , Israel

Comuna Alexandru Cel Bun, , Romania

Vladimir, , Russian Federation

Hollywood, Florida, United States

Spokane Valley, Washington, United States

Sherwood Park, Alberta, Canada

Santiago, Región Metro De Santiago, Chile

Palma De Mallorca, , Spain

Boynton Beach, Florida, United States

Adairsville, Georgia, United States

Hiroshima, , Japan

Okinawa, , Japan

Bucheon City, Gyenggi Do, , Korea, Republic Of

Den Bosch, , Netherlands

Chiba, , Japan

Gunma, , Japan

Kochi, , Japan

Saitama, , Japan

Toyama, , Japan

Stavropol, , Russian Federation

Chandler, Arizona, United States

Reseda, California, United States

West Haven, Connecticut, United States

Fort Myers, Florida, United States

Hines, Illinois, United States

Louisville, Kentucky, United States

Crowley, Louisiana, United States

Reno, Nevada, United States

Hendersonville, North Carolina, United States

Lexington, North Carolina, United States

Whiteville, North Carolina, United States

Johnstown, Pennsylvania, United States

Gonzales, Texas, United States

Caba, Buenos Aires, Argentina

Florida, Buenos Aires, Argentina

Paraná, Buenos Aires, Argentina

Berazategui, Buenos Aires, , Argentina

Capital Federal, , Argentina

Ciudad Autonoma De Buenis Aires, , Argentina

Santa Rosa, , Argentina

Hamilton, Victoria, Australia

Murdoch, Western Australia, Australia

Malmedy, , Belgium

Recife, Pernambuco, Brazil

Porto Alegre, Rio Grande Do Sul, Brazil

Blumenau, Santa Catarina, Brazil

Florianopolis, Santa Catarina, Brazil

São Paulo, , Brazil

Moncton, New Brunswick, Canada

Cornwall, Ontario, Canada

Toronto, Ontario, Canada

Montréal, Quebec, Canada

Curicó, Región Del Maule, Chile

Talca, Región Del Maule, Chile

Brandys Nad Labem, , Czechia

Sønderborg, , Denmark

Espoo, , Finland

Briis Sous Forge, , France

Marseille Cedex 03, , France

Leonberg, Baden Wuerttemberg, Germany

Donaustauf, Bayern, Germany

Garmisch Partenirchen, Bayern, Germany

Fuldatal, Hessen, Germany

Fulda, Hessen, Germany

Peine, Niedersachsen, Germany

Duisburg, Nordrhein Westfalen, Germany

Essen, Nordrhein Westfalen, Germany

Freudenberg, Nordrhein Westfalen, Germany

Gummersbach, Nordrhein Westfalen, Germany

Kleve, Nordrhein Westfalen, Germany

Bernkastel Kues, Rheinland Pfalz, Germany

Wissen, Rheinland Pfalz, Germany

Halle, Sachsen Anhalt, Germany

Luebeck, Schleswig Holstein, Germany

Saalfeld, Thueringen, Germany

Deggendorf, , Germany

Tel Aviv, , Israel

Iwate, , Japan

Mie, , Japan

Niigata, , Japan

Shizuoka, , Japan

Tochigi, , Japan

Wakayama, , Japan

Yamagata, , Japan

Cheongju Si, Chungcheongbuk Do, , Korea, Republic Of

Suwon, , Korea, Republic Of

Almelo, , Netherlands

Auckland, , New Zealand

Dunedin, , New Zealand

Newtown, Wellington, , New Zealand

Tauranga, , New Zealand

Hakadal, , Norway

Oslo, , Norway

Pueblo Libre, Lima, Peru

Caloocan City, , Philippines

Tarnów, , Poland

Guaynabo, , Puerto Rico

Mayaguez, , Puerto Rico

Ulan Ude, , Russian Federation

Vsevolozhsk, Leningrad Region, , Russian Federation

Singapore, , Singapore

Val De Grace, Pretoria, Gauteng, South Africa

Cape Town, , South Africa

Johannesburg, , South Africa

Marbella Málaga, Andalucia, Spain

Laredo, Cantabria, Spain

Torrelavega, Cantabria, Spain

Badalona, Catalonia, Spain

(Badalona) Barcelona, , Spain

(Barakaldo) Vizcaya, , Spain

Gerona, , Spain

Tarragona, , Spain

Linköping, , Sweden

Uppsala, , Sweden

Mersin, , Turkey

Vinnytsia, , Ukraine

Blackpool, Lancashire, United Kingdom

Baillieston, Glasgow, , United Kingdom

Chester, , United Kingdom

Crawley, , United Kingdom

Crownhill, Plymouth, , United Kingdom

Dundee, Scotland, , United Kingdom

Stockton On Tees, , United Kingdom

Trowbridge, , United Kingdom

Patients applied

0 patients applied

Trial Officials

GSK Clinical Trials

Study Director

GlaxoSmithKline

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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