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Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma

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ClinicalTrials.gov Identifier: NCT03248128
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The goal of asthma treatment is to achieve and maintain asthma control and to reduce the future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most effective anti- inflammatory treatment for all severities of persistent asthma. For children >=5 years of age and adolescents whose asthma is uncontrolled, low-dose ICS plus adjunctive therapy with long-acting beta agonist (LABA) is considered as effective. Thus, this study is designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component) compared to FF alone for the treatment of asthma, in subjects aged 5 to 17 years old currently uncontrolled on ICS. The study will be conducted over a total duration of approximately 29 weeks: 4 week run-in period, 24-week double-blind treatment period and 1-week follow-up period. Subjects will be randomized to receive FDC of FF/VI or FF administered via ELLIPTA® dry powder inhaler (DPI). The dose of both FF/VI and FF alone will be selected based on the age of subjects. Subjects will receive a short acting beta 2 agonist (SABA) (albuterol /salbutamol) as a rescue medication throughout the study. A total of 870 subjects will be randomized in the study. Of this, 652 subjects will be aged 5 to 11 years (cohort A), and 218 will be aged 12 to 17 years inclusive (cohort B). ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

Condition or disease Intervention/treatment Phase
Asthma Drug: FF/VI via ELLIPTA DPI Drug: FF via ELLIPTA DPI Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 870 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to receive FDC of FF/VI inhalation powder compared to FF inhalation powder, once daily in cohort A and cohort B.
Masking: Double (Participant, Investigator)
Masking Description: This will be a double blind study. Subjects and investigator will be masked.
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel Group, Multicentre, Stratified, Study Evaluating the Efficacy and Safety of Once Daily Fluticasone Furoate/Vilanterol Inhalation Powder Compared to Once Daily Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Participants Aged 5 to 17 Years Old (Inclusive) Currently Uncontrolled on Inhaled Corticosteroids
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : October 19, 2020
Estimated Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Subjects receiving FF/VI in cohort A
Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 50/25 mcg administered once daily in the morning via ELLIPTA DPI.
Drug: FF/VI via ELLIPTA DPI
ELLIPTA DPI inhaler will contain two individual blister strips; the first strip will contain FF(50 or 100 mcg) and second strip will contain VI (25 mcg).

Active Comparator: Subjects receiving FF in cohort A
Subjects will be randomized in 1:1 ratio to receive FF with a dose of 50 mcg administered once daily in the morning via ELLIPTA DPI.
Drug: FF via ELLIPTA DPI
ELLIPTA DPI inhaler will contain a single blister strip of FF (50 or 100 mcg).

Experimental: Subjects receiving FF/VI in cohort B
Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 100/25 mcg administered once daily in the morning via ELLIPTA DPI.
Drug: FF/VI via ELLIPTA DPI
ELLIPTA DPI inhaler will contain two individual blister strips; the first strip will contain FF(50 or 100 mcg) and second strip will contain VI (25 mcg).

Active Comparator: Subjects receiving FF in cohort B
Subjects will be randomized in 1:1 ratio to receive FF with a dose of 100 mcg administered once daily in the morning via ELLIPTA DPI.
Drug: FF via ELLIPTA DPI
ELLIPTA DPI inhaler will contain a single blister strip of FF (50 or 100 mcg).




Primary Outcome Measures :
  1. Cohort A: Change from Baseline, in pre-dose (i.e. trough) morning peak expiratory flow (PEF) averaged over weeks 1-12 of the treatment period [ Time Frame: Baseline and up to Week 12 ]
    PEF is defined as the maximum speed of expiration of a person. PEF will be measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements will be recorded in the daily diary.

  2. Cohort A and B: Weighted mean forced expiratory volume in 1 second (FEV1) (0-4 hours) at Week 12 [ Time Frame: Week 12 ]
    Pulmonary function will be measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 will be measured using a standardized calibrated spirometer prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use.


Secondary Outcome Measures :
  1. Cohort A: Weighted mean of FEV1 (0-4 hours) at Week 12 [ Time Frame: Week 12 ]
    Pulmonary function will be measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 will be measured using a standardized calibrated spirometer prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use.

  2. Cohort A and B: Change from Baseline, in pre-dose (i.e. trough) morning PEF averaged over weeks 1-12 of the treatment period [ Time Frame: Baseline and up to Week 12 ]
    PEF is defined as the maximum speed of expiration of a person. PEF will be measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements will be recorded in the daily diary.

  3. Cohort A and B: Change from Baseline in the percentage of rescue-free 24-hour periods over weeks 1-12 of the treatment period [ Time Frame: Baseline and up to Week 12 ]
    The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night will be recorded in a daily electronic diary. A 24-hour period in which the response of subjects to both the morning and evening assessments indicated no use of rescue medication will be considered as 'rescue free'.

  4. Cohort A and B: Change from Baseline in the percentage of symptom-free 24-hour periods over weeks 1-12 of the treatment period [ Time Frame: Baseline and up to Week 12 ]
    The symptom-free days will be recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour period in which the response of subjects to both the morning and evening assessments indicated no symptoms will be considered as 'symptom free'.

  5. Cohort A and B: Change from Baseline in morning (ante meridiem [AM]) FEV1 at Week 12 [ Time Frame: Baseline and at Week 12 ]
    Pulmonary function will be measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 will be measured using a standardized calibrated spirometer prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use.

  6. Cohort A and B: Change from Baseline in asthma control questionnaire (ACQ-5) at Week 24 [ Time Frame: Baseline and at Week 24 ]
    The ACQ-5 is a five-item questionnaire, which includes five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze). The questions will enquire about the frequency and/or severity of symptoms over the previous week and will be self-completed by the subjects. The response options for all these questions will consist of a scale ranging from 0 (no impairment/limitation) to 6 (total impairment/ limitation). A score of <0.75 indicates well-controlled asthma and a score >=1.5 indicates poorly controlled asthma. A change of >=0.5 in score suggests a clinically important change in score.

  7. Cohort A and B: Number of subjects with incidence of exacerbations over the 24-Week treatment period [ Time Frame: Up to Week 24 ]
    An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Information regarding asthma exacerbations will be collected and recorded over the specified period.

  8. Cohort A and B: Number of subjects with adverse events (AEs), serious adverse events (SAEs) [ Time Frame: Up to Week 25 ]
    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.

  9. Cohort A and B: Number of subjects with abnormal electrocardiogram (ECG) findings [ Time Frame: Up to Week 24 ]
    A single 12-lead ECG will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected (QTc).

  10. Cohort A and B:Number of subjects with abnormal fasting blood glucose levels [ Time Frame: Up to Week 24 ]
    Blood samples will be collected for evaluation of fasting blood glucose pre- and post-treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For all subjects: Between 5 and 17 years of age inclusive, at the time of signing the informed consent.
  • A history of symptoms consistent with a diagnosis of asthma for at least 6 months.
  • Pre-bronchodilator FEV1 >50 percent to <=90 percent predicted normal. A minimum of 2 efforts that are considered acceptable (not necessarily repeatable) are required to be eligible.
  • Lung function reversibility defined as an increase of >=12 percent in FEV1 within 10 to 40 minutes following 2 to 4 inhalations of salbutamol inhalation aerosol (or 1 nebulized treatment with albuterol/salbutamol solution). Use of a spacer is permitted.
  • Uncontrolled asthma, with a childhood asthma control test (cACT)/ACT score <=19.
  • Receiving stable asthma therapy (SABA inhaler plus ICS [total daily dose <=FP 250 micrograms (mcg) or equivalent]) for at least 4 weeks prior to Visit 1 (i.e. screening).
  • Able to replace their current SABA treatment with salbutamol aerosol inhaler at Visit 1 for use as needed for the duration of the study. Salbutamol metered dose inhaler (MDI) will be administered with or without a spacer, to be used as determined by the investigator. The use or non-use of the spacer should be consistent for an individual subject throughout the study.
  • Male or female subjects will be included. Females of reproductive potential must agree to follow 1 of the options listed (which include abstinence) in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until at least five terminal half-lives or until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up call. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
  • Written informed consent from at least 1 parent/care giver (legal guardian) and accompanying informed assent from the subject (where the subject is able to provide assent) prior to admission to the study. If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement. The study investigator is accountable for determining a child's capacity to assent to participation in a research study, taking into consideration any standards set by the responsible independent ethics committee (IEC); subject and their legal guardian(s) understand that the study requires them to be treated on an outpatient basis; subject and their legal guardian(s) understand that they must comply with study medication and study assessments including recording of PEF and rescue SABA use, attending scheduled study visits, and being accessible by a telephone call.
  • For subjects eligible for randomization; asthma control: uncontrolled asthma, with a cACT/ACT score <=19.
  • A technically acceptable pre-bronchodilator FEV1 >50 percent to <=90 percent predicted normal at Visit 2. A minimum of 2 efforts that are considered acceptable and repeatable following the over read are required to be eligible.
  • Symptoms and rescue use: demonstrated and reported in a daily diary symptoms of asthma (a score of >=1 on the day-time or night-time asthma symptom scores) and/or daily albuterol/salbutamol on at least 3 of the last 7 consecutive days of the run-in period (not including the date of randomization).
  • Compliance with run-in medication: compliance is defined as use of run-in medication on at least 4 of the last 7 consecutive days of the run-in period (not including the date of randomization) recorded in the electronic subject diary.
  • Compliance with completion of the daily diary reporting: defined as completion of all questions on 4 out of the last 7 days during the run-in period (not including the date of randomization).

Exclusion Criteria:

  • For all subjects: History of life threatening asthma defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
  • Any asthma exacerbation requiring the use of oral steroids within 6 weeks of Visit 1, systemic or depot corticosteroids within 12 weeks of Visit 1, or ER attendance within 3 months of Visit 1 or hospitalization within 6 months of Visit 1.
  • A culture documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that has not resolved within 4 weeks of Visit 1 and which led to a change in asthma management or, in the opinion of the investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
  • Clinical visual evidence of oropharyngeal candidiasis.
  • Fasting blood glucose at screening >100 milligrams/deciliter (mg/dL) (5.6 moles per liter [mol/L]).
  • Obesity (Body Mass Index [BMI] above the 97th centile based on the centers for disease control and prevention [CDC] charts).
  • Any significant abnormality or medical condition identified at the screening medical assessment (including serious psychological disorder) that in the investigator's opinion, preclude entry into the study due to risk to the subject or that may interfere with the conduct and/or outcome of the study.
  • QTc >450 milliseconds (msec) or QTc >480 msec in subjects with bundle branch block or any other clinically significant abnormality in the screening 12-lead ECG.
  • Use of any prohibited medications.
  • Present use of any tobacco products.
  • Drug allergies: any adverse reaction including immediate or delayed hypersensitivity to any beta 2-agonists, sympathomimetic drug or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the ELLIPTA Inhaler (i.e. lactose or magnesium stearate).
  • Milk Protein Allergy: history of severe milk protein allergy.
  • Participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the study treatment (whichever is longer).
  • Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.
  • An affiliation with the investigator site: the parents/guardians or child is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  • The parent or guardian has a history of psychiatric disease, intellectual deficiency, substance abuse or other condition (example, inability to read, comprehend or write) which may affect: validity of consent to participate in the study; adequate supervision of the subject during the study; compliance of subject with study medication and study procedures (example, completion of daily diary, attending scheduled clinic visits); subject safety and well-being.
  • Children in care: children who are wards of the government or state are not eligible for participation in this study.
  • For subjects eligible for randomization; Changes in asthma medication that occur after screening.
  • Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
  • Evidence of an exacerbation, defined as a: deterioration of asthma requiring the use of oral corticosteroids for at least 3 days, or a depot corticosteroid injection, or an in-patient hospitalization due to asthma that required systemic corticosteroids between screening and randomization.
  • Clinical visual evidence of oropharyngeal candidiasis at the randomization Visit.
  • Unable to use the ELLIPTA inhaler correctly.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248128


Contacts
Layout table for location contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

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Locations
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United States, Alabama
GSK Investigational Site Recruiting
Hoover, Alabama, United States, 35244
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sunena C Argo         
United States, Arkansas
GSK Investigational Site Recruiting
Little Rock, Arkansas, United States, 72205
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Karl V Sitz         
United States, California
GSK Investigational Site Recruiting
Huntington Beach, California, United States, 92648
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rachel Zabaneh         
GSK Investigational Site Recruiting
Riverside, California, United States, 92506
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: William Cherry         
United States, Colorado
GSK Investigational Site Recruiting
Denver, Colorado, United States, 80206
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ronina Covar         
United States, Florida
GSK Investigational Site Recruiting
Hialeah, Florida, United States, 33016
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jose Carpio         
GSK Investigational Site Recruiting
Homestead, Florida, United States, 33030
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Maria Cubillas         
GSK Investigational Site Recruiting
Miami Lakes, Florida, United States, 33014
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Manuel Hernandez         
GSK Investigational Site Recruiting
Miami, Florida, United States, 33134
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Yamil Canaan         
GSK Investigational Site Recruiting
Miami, Florida, United States, 33135
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ana Acosta         
GSK Investigational Site Recruiting
Miami, Florida, United States, 33135
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rafael Cardenas         
GSK Investigational Site Recruiting
Miami, Florida, United States, 33142
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Armando Acevedo         
GSK Investigational Site Recruiting
Miami, Florida, United States, 33186
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Edel Abreu         
GSK Investigational Site Recruiting
Miami, Florida, United States, 33186
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jose Acosta         
GSK Investigational Site Recruiting
Ocala, Florida, United States, 34470
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: G. Edward Stewart         
United States, Georgia
GSK Investigational Site Recruiting
Gainesville, Georgia, United States, 30501
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Michael J. Maloney         
United States, Illinois
GSK Investigational Site Recruiting
Evanston, Illinois, United States, 60201
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Giselle S Mosnaim         
United States, Indiana
GSK Investigational Site Recruiting
Evansville, Indiana, United States, 47715
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: David Brougher         
United States, Iowa
GSK Investigational Site Recruiting
Des Moines, Iowa, United States, 50309
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Joi Lucas         
United States, Kentucky
GSK Investigational Site Completed
Owensboro, Kentucky, United States, 42301
United States, Maryland
GSK Investigational Site Completed
Baltimore, Maryland, United States, 21236
GSK Investigational Site Recruiting
White Marsh, Maryland, United States, 21162
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Manav Singla         
United States, Michigan
GSK Investigational Site Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jeffrey G Leflein         
United States, New Jersey
GSK Investigational Site Recruiting
Belleville, New Jersey, United States, 07109
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mark Weinstein         
GSK Investigational Site Recruiting
Brick, New Jersey, United States, 08724
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bruce A DeCotiis         
GSK Investigational Site Completed
Piscataway, New Jersey, United States, 08854
GSK Investigational Site Recruiting
Verona, New Jersey, United States, 07044
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Arthur F Fost         
United States, New York
GSK Investigational Site Recruiting
Great Neck, New York, United States, 11021
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Punita Ponda         
United States, North Carolina
GSK Investigational Site Recruiting
Asheville, North Carolina, United States, 28801
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: David Cypcar         
GSK Investigational Site Recruiting
Charlotte, North Carolina, United States, 28277
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hugh Black         
GSK Investigational Site Recruiting
Raleigh, North Carolina, United States, 27607
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Karen D Dunn         
United States, Ohio
GSK Investigational Site Completed
Grove City, Ohio, United States, 43123
United States, Oregon
GSK Investigational Site Recruiting
Medford, Oregon, United States, 97504
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Edward M. Kerwin         
United States, Pennsylvania
GSK Investigational Site Completed
Wexford, Pennsylvania, United States, 15090
United States, South Carolina
GSK Investigational Site Recruiting
Orangeburg, South Carolina, United States, 29118-2040
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Richard Elliot Sterling         
GSK Investigational Site Completed
Spartanburg, South Carolina, United States, 29303
GSK Investigational Site Recruiting
Summerville, South Carolina, United States, 29485
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Andrew E Davidson         
United States, Texas
GSK Investigational Site Recruiting
Houston, Texas, United States, 77055
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Oscar De Valle         
GSK Investigational Site Completed
Lewisville, Texas, United States, 75067
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78207
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Dennis E Dilley         
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78215
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Carl Dukes         
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78249
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Kelly J Smith         
GSK Investigational Site Recruiting
Waco, Texas, United States, 76712
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Niran J. Amar         
United States, Wisconsin
GSK Investigational Site Recruiting
Madison, Wisconsin, United States, 53792
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mark H Moss         
Argentina
GSK Investigational Site Recruiting
Berazategui, Buenos Aires, Argentina, 1837
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Marcelo José Fernández         
GSK Investigational Site Recruiting
Caba, Buenos Aires, Argentina, C1028AAP
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Adriana Sosso         
GSK Investigational Site Recruiting
Caba, Buenos Aires, Argentina, C1425BEN
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Anahí Yañez         
GSK Investigational Site Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1122AAK
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Horacio Budani         
GSK Investigational Site Recruiting
Florida, Buenos Aires, Argentina, 1602
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Miguel A Bergna         
GSK Investigational Site Recruiting
La Plata, Buenos Aires, Argentina, 1900
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Claudia Cecilia Varas         
GSK Investigational Site Recruiting
Lanús, Buenos Aires, Argentina, B1824KAJ
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Adriana Monica Gosn         
GSK Investigational Site Recruiting
Mar del Plata, Buenos Aires, Argentina, 7600
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jorge Taborda         
GSK Investigational Site Recruiting
Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Iris Victoria Medina         
GSK Investigational Site Recruiting
Buenos Aires, Argentina, C1121ABE
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mónica Silvia De Gennaro         
GSK Investigational Site Recruiting
Buenos Aires, Argentina, C1425FVH
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rita Gisela Delgado Vizcarra         
GSK Investigational Site Recruiting
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jorge Fernando Maspero         
GSK Investigational Site Recruiting
Rosario, Argentina, S2000BRH
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gabriel Gattolin         
Canada, Ontario
GSK Investigational Site Recruiting
Brampton, Ontario, Canada, L6T 0G1
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Naresh K. Aggarwal         
GSK Investigational Site Recruiting
Windsor, Ontario, Canada, N8X2G1
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Joel Liem         
Canada
GSK Investigational Site Recruiting
Québec, Canada, G1V 4W2
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Remi Gagnon         
China
GSK Investigational Site Recruiting
Beijing, China, 100045
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Shunying Zhao         
Germany
GSK Investigational Site Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69126
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Eva Fritzsching         
GSK Investigational Site Recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68161
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Falko Panzer         
GSK Investigational Site Recruiting
Rosenheim, Bayern, Germany, 83026
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Otto Laub         
GSK Investigational Site Completed
Geesthacht, Schleswig-Holstein, Germany, 21502
Italy
GSK Investigational Site Recruiting
Parma, Emilia-Romagna, Italy, 43126
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Giovanna Pisi         
GSK Investigational Site Completed
Roma, Lazio, Italy, 00165
GSK Investigational Site Recruiting
Bergamo, Lombardia, Italy, 24127
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Lorenzo D'Antiga         
GSK Investigational Site Recruiting
Milano, Lombardia, Italy, 20122
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Paola Giovanna Marchisio         
GSK Investigational Site Recruiting
Milano, Lombardia, Italy, 20154
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gian Vincenzo Zuccotti         
GSK Investigational Site Recruiting
Ancona, Marche, Italy, 60123
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Salvatore Cazzato         
GSK Investigational Site Recruiting
Palermo, Sicilia, Italy, 9000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Stefania La Grutta         
GSK Investigational Site Recruiting
Perugia, Umbria, Italy, 06156
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Susanna Esposito         
Japan
GSK Investigational Site Recruiting
Chiba, Japan, 260-0001
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Toshikazu Tsubaki         
GSK Investigational Site Recruiting
Fukui, Japan, 918-8205
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Michio Hiratani         
GSK Investigational Site Recruiting
Hiroshima, Japan, 721-8511
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Masanori Ikeda         
GSK Investigational Site Recruiting
Hyogo, Japan, 653-0836
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Akihiko Hirase         
GSK Investigational Site Recruiting
Tokyo, Japan, 154-0017
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Masahiko Tsuda         
GSK Investigational Site Recruiting
Tokyo, Japan, 157-0066
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Akiyoshi Sasamoto         
Mexico
GSK Investigational Site Recruiting
Guadalajara, Jalisco, Mexico, 44100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Dante Daniel Hernández-Colín         
GSK Investigational Site Recruiting
Guadalajara, Jalisco, Mexico, 44670
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Luis Virgen-Carrillo         
GSK Investigational Site Recruiting
Zapopan, Jalisco, Mexico, 45070
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Alfredo Gazca-Aguilar         
GSK Investigational Site Recruiting
Monterrey, Nuevo León, Mexico, 64000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Héctor Joel Velarde-Mora         
GSK Investigational Site Recruiting
Monterrey, Nuevo León, Mexico, 64710
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sergio Garza-Salinas         
GSK Investigational Site Completed
Villahermosa, Tabasco, Mexico, 86035
Poland
GSK Investigational Site Completed
Bialystok, Poland, 15-430
GSK Investigational Site Recruiting
Bialystok, Poland, 15879
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ewa Michnowska-Tryburska         
GSK Investigational Site Recruiting
Bydgoszcz, Poland, 85-796
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ewa Banach-Wawrzenczyk         
GSK Investigational Site Recruiting
Krakow, Poland, 31-011
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Anna Chmielewska         
GSK Investigational Site Recruiting
Lodz, Poland, 90-329
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Agnieszka Brzozowska         
GSK Investigational Site Recruiting
Ostrow Wielkopolski, Poland, 63-400
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Violetta Balicka         
GSK Investigational Site Recruiting
Ostrowiec Swietokrzyski, Poland, 27-400
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Anna Olech- Cudzik         
GSK Investigational Site Recruiting
Poznan, Poland, 60-693
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ewa Springer         
GSK Investigational Site Recruiting
Skierniewice, Poland, 96-100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bozena Kucinska         
GSK Investigational Site Recruiting
Strzelce Opolskie, Poland, 47-100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Lucyna Dymek         
GSK Investigational Site Recruiting
Tarnow, Poland, 33-100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bernadetta Majorek-Olechowska         
GSK Investigational Site Completed
Zabrze, Poland, 41-800
Romania
GSK Investigational Site Recruiting
Brasov, Romania, 500091
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ioana Gozman         
GSK Investigational Site Recruiting
Brasov, Romania, 500283
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Laura Dracea         
GSK Investigational Site Recruiting
Bucuresti, Romania, 011025
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Dan Gafitei         
GSK Investigational Site Recruiting
Bucuresti, Romania, 020395
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mihai Craiu         
GSK Investigational Site Recruiting
Bucuresti, Romania, 030961
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Roxana Maria Nemes         
GSK Investigational Site Recruiting
Bucuresti, Romania, 051543
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Encica Marianthi         
GSK Investigational Site Recruiting
Targu Mures, Romania, 540136
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Brandusa Capilna         
Russian Federation
GSK Investigational Site Recruiting
Moscow, Russian Federation, 1154461
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Vera Revyakina         
GSK Investigational Site Recruiting
Moscow, Russian Federation, 119435
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Natalia A Geppe         
GSK Investigational Site Recruiting
Moscow, Russian Federation, 119991
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Anna A Alekseeva         
GSK Investigational Site Recruiting
Moscow, Russian Federation, 129110
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Natalia I. Ursova         
GSK Investigational Site Recruiting
Saint Petersburg, Russian Federation, 191036
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Natalya Soroka         
GSK Investigational Site Recruiting
Saint Petersburg, Russian Federation, 192148
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Anna Nikolaevna Galustyan         
GSK Investigational Site Recruiting
Saint Petersburg, Russian Federation, 192212
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Olga Zhiglinskaya         
GSK Investigational Site Recruiting
Saint Petersburg, Russian Federation, 194291
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Nikolay N Klimko         
GSK Investigational Site Recruiting
Saint Petersburg, Russian Federation, 196240
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Tatiana Pak         
GSK Investigational Site Recruiting
Saint Petersburg, Russian Federation, 196657
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Svetlana Laleko         
GSK Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 196191
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Tatiana Antonova         
GSK Investigational Site Recruiting
Samara, Russian Federation, 443031
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Natalia A Mokina         
GSK Investigational Site Recruiting
Saransk, Russian Federation, 430000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Larisa Balykova         
GSK Investigational Site Recruiting
St'Petersburg, Russian Federation, 191144
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Irina V Makarova         
GSK Investigational Site Recruiting
St. Petersburg, Russian Federation, 194223
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Irina Melnikova         
GSK Investigational Site Recruiting
Tomsk, Russian Federation, 634 050
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Olga S Fedorova         
GSK Investigational Site Recruiting
Volgograd, Russian Federation, 400131
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ivan N Shishimorov         
GSK Investigational Site Recruiting
Voronezh, Russian Federation, 394036
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Elena Chertok         
GSK Investigational Site Recruiting
Yaroslavl, Russian Federation, 150003
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Irina Asherova         
South Africa
GSK Investigational Site Recruiting
Boksburg, Gauteng, South Africa, 1459
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Agatha C Wilhase         
GSK Investigational Site Recruiting
Johannesburg, Gauteng, South Africa, 1818
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Qasim Bhorat         
GSK Investigational Site Recruiting
Middelburg, Mpumalanga, South Africa, 1055
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mohammed Siddique Tayob         
GSK Investigational Site Recruiting
Panorama, Western Province, South Africa, 7500
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jan Vermeulen         
GSK Investigational Site Recruiting
Bellville, South Africa, 7530
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Haylene Nell         
GSK Investigational Site Recruiting
Cape Town, South Africa, 7700
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Shaunagh Emanuel         
GSK Investigational Site Recruiting
Durban, South Africa, 4001
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Farzana Hoosen         
GSK Investigational Site Recruiting
Pretoria, South Africa, 0001
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Nazira Carrim-Ganey         
GSK Investigational Site Recruiting
Pretoria, South Africa, 0181
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Heidi Siebert         
GSK Investigational Site Recruiting
Soweto, South Africa, 1818
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Nokuthula Phoshoko         
GSK Investigational Site Recruiting
Umkomaas, South Africa, 4170
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Trevenesan Padayachee         
GSK Investigational Site Recruiting
Vosloorus Ext 2, South Africa, 1475
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Primrose Mabale         
Spain
GSK Investigational Site Recruiting
Badalona, Spain, 08916
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Albert Roger Reig         
GSK Investigational Site Recruiting
Barcelona, Spain, 08003
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Araceli Caballero Rabasco         
GSK Investigational Site Recruiting
Barcelona, Spain, 08035
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Teresa Garriga Baraut         
GSK Investigational Site Recruiting
Madrid, Spain, 28041
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Carmen Troyano Rivas         
GSK Investigational Site Recruiting
Valencia, Spain, 46026
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Antonio Nieto García         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03248128     History of Changes
Other Study ID Numbers: 107116
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Fluticasone furoate
Efficacy
Vilanterol
Asthma
Safety
GW642444
GW685698

Additional relevant MeSH terms:
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Asthma
Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents