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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02924688




Registration number
NCT02924688
Ethics application status
Date submitted
12/09/2016
Date registered
5/10/2016

Titles & IDs
Public title
A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma
Scientific title
A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combination of FF/VI, Administered Once-daily Via a Dry Powder Inhaler in Subjects With Inadequately Controlled Asthma
Secondary ID [1] 0 0
2016-001304-37
Secondary ID [2] 0 0
205715
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FF/UMEC/VI (100/31.25/25) mcg
Treatment: Drugs - FF/UMEC/VI (100/62.5/25) mcg
Treatment: Drugs - FF/UMEC/VI (200/31.25/25) mcg
Treatment: Drugs - FF/UMEC/VI (200/62.5/25) mcg
Treatment: Drugs - FF/VI (100/25) mcg
Treatment: Drugs - FF/VI (200/25) mcg
Treatment: Drugs - Fluticasone/salmeterol (FSC)
Treatment: Drugs - Albuterol/salbutamol
Treatment: Devices - ELLIPTA DPI
Treatment: Devices - DISKUS DPI
Treatment: Devices - METERED-DOSE INHALER (MDI)

Experimental: FF/UMEC/VI (100/31.25/25) mcg closed triple therapy - Subjects will receive FF/UMEC/VI (100/31.25/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.

Experimental: FF/UMEC/VI (100/62.5/25) mcg closed triple therapy - Subjects will receive FF/UMEC/VI (100/62.5/25) mcg inhalation powder via DPI, once daily in the morning. Subjects will also receive albuterol/salbutamol as a rescue medication when needed during the treatment period.

Experimental: FF/UMEC/VI (200/31.25/25) mcg closed triple therapy - Subjects will receive FF/UMEC/VI (200/31.25/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.

Experimental: FF/UMEC/VI (200/62.5/25) mcg closed triple therapy - Subjects may receive FF/UMEC/VI (200/62.5/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.

Active comparator: FF/VI (100/25) mcg dual combination therapy - Subjects will receive FF/VI (100/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.

Active comparator: FF/VI (200/25) mcg dual combination therapy - Subjects will receive FF/VI (200/25) mcg inhalation powder via DPI, once daily in the morning. Subjects may receive albuterol/salbutamol as a rescue medication when needed during the treatment period.


Treatment: Drugs: FF/UMEC/VI (100/31.25/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation once-daily \[QD\] in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.

Treatment: Drugs: FF/UMEC/VI (100/62.5/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.

Treatment: Drugs: FF/UMEC/VI (200/31.25/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.

Treatment: Drugs: FF/UMEC/VI (200/62.5/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.

Treatment: Drugs: FF/VI (100/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains VI 25 mcg in each blister.

Treatment: Drugs: FF/VI (200/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains VI 25 mcg in each blister.

Treatment: Drugs: Fluticasone/salmeterol (FSC)
Dry white powder delivered via the DISKUS DPI (one inhalation twice daily: one in the morning and one in the evening). The DISKUS DPI holds a strip of 60 blisters; each blister contains FP 250 mcg and 50 mcg of salmeterol.

Treatment: Drugs: Albuterol/salbutamol
This is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.

Treatment: Devices: ELLIPTA DPI
The ELLIPTA device will be used during the stabilization period and the treatment period. The ELLIPTA DPI is a moulded plastic two-sided device that can hold two individual blister strips which contain powder formulation for oral inhalation.

Treatment: Devices: DISKUS DPI
The DISKUS device will be used during the run-in period. The DISKUS DPI is a plastic inhalation delivery system containing a single-foil blister strip of a powder formulation of FSC for oral inhalation.

Treatment: Devices: METERED-DOSE INHALER (MDI)
Albuterol/salbutamol (rescue medication) will be delivered via metered-dose inhaler (MDI) will be used for reversibility testing.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Timepoint [1] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [1] 0 0
Annualized Rate of Moderate and Severe Asthma Exacerbations
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [2] 0 0
Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Study Treatment at Week 24
Timepoint [2] 0 0
Baseline (pre-dose at Day 1) and 3 hours post dose at Week 24
Secondary outcome [3] 0 0
Mean Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 24
Timepoint [3] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [4] 0 0
Mean Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 24
Timepoint [4] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [5] 0 0
Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score Over Weeks 21 to 24 (Inclusive) of the Treatment Period
Timepoint [5] 0 0
Baseline (14 days prior to randomization) and Weeks 21 to 24
Secondary outcome [6] 0 0
Number of Participants With Any Serious Adverse Event (SAE) and Common (>=3%) Non-SAE
Timepoint [6] 0 0
Up to Week 52
Secondary outcome [7] 0 0
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Timepoint [7] 0 0
Up to Week 52
Secondary outcome [8] 0 0
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24
Timepoint [8] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [9] 0 0
Mean Change From Baseline in Pulse Rate at Week 24
Timepoint [9] 0 0
Baseline (pre-dose at Day 1) and Week 24
Secondary outcome [10] 0 0
Number of Participants With Abnormal Clinical Chemistry Values
Timepoint [10] 0 0
Up to Week 52
Secondary outcome [11] 0 0
Number of Participants With Abnormal Hematology Values
Timepoint [11] 0 0
Up to Week 52

Eligibility
Key inclusion criteria
Inclusion Criteria for Screening

* Age: 18 years of age or older at the time of signing the informed consent.
* Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health at least one year prior to Visit 0.
* Symptomatic: Subjects with inadequately controlled asthma (ACQ-6 score >=1.5) despite ICS/LABA maintenance therapy at Visit 1.
* Asthma Control: In the 1 year prior to Visit 1

* A documented healthcare contact for acute asthma symptoms or
* A documented temporary change in asthma therapy for acute asthma symptoms, according to a pre-specified asthma action plan (or equivalent)
* Current Asthma Maintenance Therapy: Subjects are eligible if they have required daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of >250 mcg/day fluticasone proprionate [FP, or equivalent]).
* Spirometry: A best pre-bronchodilator morning (ante meridian [AM]) FEV1 >=30% and <85% of the predicted normal value at Visit 1. Predicted values will be based upon the European Respiratory Society (ERS) Global Lung Function Initiative.
* Reversibility of Disease: airway reversibility defined as >=12% and >=200 milliliter (mL) increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1.
* If the subject does not meet the above reversibility criteria at Visit 1 then the reversibility assessment may be repeated once within 7 days of Visit 1 if either criteria a) or b) are met: a) >=9% increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol at Visit 1. b) Documented evidence of a reversibility assessment within 1 year prior to Visit 1 which demonstrated a post-bronchodilator increase in FEV1 of >=12% and >=200 mL.

Should the subject successfully demonstrate airway reversibility (defined as >=12% and >=200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of albuterol/salbutamol aerosol) at the second attempt then, provided that all other eligibility criteria assessed at Visit 1 are met, the subject may enter the 3-week run-in period.

* Short-Acting beta2 Agonists (SABAs): All subjects must be able to replace their current SABA inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed for the duration of the study. Subjects must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
* Male or eligible Female, defined as having documentation of non-reproductive potential or reproductive potential as follows:

A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test), not lactating, is not planning on becoming pregnant during the study and at least one of the following conditions applies: Non-reproductive potential defined as pre-menopausal females with documented tubal ligation or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion or hysterectomy or documented bilateral oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile (e.g., age appropriate, >45 years, in the absence of hormone replacement therapy). In questionable cases for women <60 years of age, a blood sample with simultaneous follicle stimulating hormone and estradiol falling into the central laboratory's postmenopausal reference range is confirmatory. Females under 60 years of age, who are on hormone replacement therapy (HRT) and whose menopausal status is in doubt, are required to use a highly effective method to avoid pregnancy if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, subjects can resume use of HRT during the study without use of a highly effective method to avoid pregnancy; Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from the screening visit until after the last dose of study medication and completion of the follow-up visit. The Investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.

* Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form and in this protocol. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for Screening

* Pneumonia: Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
* Asthma Exacerbation: Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit 1. Note: Subjects requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the subject's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification) and they are considered appropriate for enrolment into this study of up to 12 month's duration.
* Chronic Obstructive Pulmonary Disease: Subjects with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, including history of exposure to risk factors (i.e., especially tobacco smoke, occupational dusts and chemicals, smoke from home cooking and heating fuels) and a post-albuterol/salbutamol FEV1/Forced Vital Capacity (FVC) ratio of <0.70 and a post-albuterol/salbutamol FEV1 of =<70% of predicted normal values and onset of disease >=40 years of age.
* Concurrent respiratory disorders: Subjects with current evidence of pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases or abnormalities other than asthma.
* Risk Factors for Pneumonia: Immune suppression (e.g., human immunodeficiency virus, 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 body mass index (BMI), severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator.
* 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, hypoalbuminemia, 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.
* Clinically significant Electrocardiogram abnormality: Evidence of a clinically significant abnormality in the 12-lead ECG performed during screening. The 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 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 (BPM); sustained or non-sustained 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 by Fridericia's formula (QTcF) >=500 milliseconds (msec) in subjects with QRS <120 msec and QTcF >=530 msec in subjects with QRS >=120 msec.
* 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.
* Antimuscarinic effects: Subjects with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the Investigator the benefit outweighs the risk and that the condition would not contraindicate 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.
* 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.
* Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 6-hour period required prior to spirometry testing at each study visit.
* Tobacco Use: Subjects who are: Current smokers (defined as subjects who have used inhaled tobacco products within the 12 months prior to Visit 1 [i.e., cigarettes, e-cigarettes/vaping, cigars or pipe tobacco]) or former smokers with a smoking history of >=10 pack years (e.g., >=20 cigarettes/day for 10 years).
* Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
* Allergy or Hypersensitivity: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate.
* 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.
* 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.

Inclusion Criteria for Enrolment

* Inadequately controlled asthma: Subjects with inadequately controlled asthma (ACQ-6 score >=1.5) at Visit 2.
* Percent-predicted FEV1: A best pre-bronchodilator morning (AM) FEV1 >=30% and <90% of the predicted normal value at Visit 2. Predicted values will be based upon the ERS Global Lung Function Initiative
* Liver function tests at Visit 1: alanine aminotransferase (ALT) <2 x upper limit of normal (ULN); alkaline phosphatase <=1.5xULN; bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
* Compliance with completion of the Daily eDiary reporting defined as completion of all questions/assessments on >=4 of the last 7 days during the run-in period.

Exclusion Criteria for Enrolment

* Respiratory Infection: 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.
* Severe asthma exacerbation: Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
* Asthma medication: Changes in asthma medication (excluding run-in medication and albuterol/salbutamol inhalation aerosol provided at Visit 1).
* Laboratory test abnormalities: Evidence of clinically significant abnormal laboratory tests during screening or run-in which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality.

Inclusion Criteria for Randomization

* Compliance with completion of the Daily eDiary reporting defined as completion of all questions/assessments on >=4 of the last 7 days during the stabilization period.

Exclusion Criteria for Randomization

* Respiratory Infection: Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the stabilization 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.
* Severe asthma exacerbation: Evidence of a severe exacerbation during enrolment or the stabilization period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
* Asthma medication: Changes in asthma medication (excluding stabilization period medication provided at Visit 2 and albuterol/salbutamol inhalation aerosol provided at Visit 1).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/02/2019
Sample size
Target
Accrual to date
Final
2436
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [3] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [4] 0 0
GSK Investigational Site - Sherwood
Recruitment hospital [5] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [6] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [7] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [8] 0 0
GSK Investigational Site - Murdoch
Recruitment hospital [9] 0 0
GSK Investigational Site - Golden Beach
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4075 - Sherwood
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3169 - Clayton
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
4551 - Golden Beach
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
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Louisiana
Country [13] 0 0
United States of America
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Maryland
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Michigan
Country [15] 0 0
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State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
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New York
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United States of America
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North Carolina
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Ohio
Country [22] 0 0
United States of America
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Oklahoma
Country [23] 0 0
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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South Carolina
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United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Argentina
State/province [31] 0 0
Buenos Aires
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Argentina
State/province [32] 0 0
Córdova
Country [33] 0 0
Argentina
State/province [33] 0 0
Mendoza
Country [34] 0 0
Argentina
State/province [34] 0 0
Santa Fe
Country [35] 0 0
Argentina
State/province [35] 0 0
Berazategui
Country [36] 0 0
Argentina
State/province [36] 0 0
Ciudad Autonoma de Buenos Aires
Country [37] 0 0
Argentina
State/province [37] 0 0
Ciudad Autónoma de Buenos Aires
Country [38] 0 0
Argentina
State/province [38] 0 0
Cordoba
Country [39] 0 0
Argentina
State/province [39] 0 0
Tucuman
Country [40] 0 0
Canada
State/province [40] 0 0
Newfoundland and Labrador
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Canada
State/province [43] 0 0
Québec
Country [44] 0 0
Germany
State/province [44] 0 0
Hessen
Country [45] 0 0
Germany
State/province [45] 0 0
Nordrhein-Westfalen
Country [46] 0 0
Germany
State/province [46] 0 0
Rheinland-Pfalz
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Germany
State/province [47] 0 0
Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Hamburg
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Lombardia
Country [55] 0 0
Italy
State/province [55] 0 0
Marche
Country [56] 0 0
Italy
State/province [56] 0 0
Piemonte
Country [57] 0 0
Italy
State/province [57] 0 0
Puglia
Country [58] 0 0
Italy
State/province [58] 0 0
Sicilia
Country [59] 0 0
Italy
State/province [59] 0 0
Toscana
Country [60] 0 0
Japan
State/province [60] 0 0
Aichi
Country [61] 0 0
Japan
State/province [61] 0 0
Chiba
Country [62] 0 0
Japan
State/province [62] 0 0
Fukui
Country [63] 0 0
Japan
State/province [63] 0 0
Fukuoka
Country [64] 0 0
Japan
State/province [64] 0 0
Gifu
Country [65] 0 0
Japan
State/province [65] 0 0
Hiroshima
Country [66] 0 0
Japan
State/province [66] 0 0
Hokkaido
Country [67] 0 0
Japan
State/province [67] 0 0
Hyogo
Country [68] 0 0
Japan
State/province [68] 0 0
Ibaraki
Country [69] 0 0
Japan
State/province [69] 0 0
Kagawa
Country [70] 0 0
Japan
State/province [70] 0 0
Kanagawa
Country [71] 0 0
Japan
State/province [71] 0 0
Kyoto
Country [72] 0 0
Japan
State/province [72] 0 0
Mie
Country [73] 0 0
Japan
State/province [73] 0 0
Miyagi
Country [74] 0 0
Japan
State/province [74] 0 0
Nagano
Country [75] 0 0
Japan
State/province [75] 0 0
Nagasaki
Country [76] 0 0
Japan
State/province [76] 0 0
Nara
Country [77] 0 0
Japan
State/province [77] 0 0
Oita
Country [78] 0 0
Japan
State/province [78] 0 0
Okayama
Country [79] 0 0
Japan
State/province [79] 0 0
Okinawa
Country [80] 0 0
Japan
State/province [80] 0 0
Osaka
Country [81] 0 0
Japan
State/province [81] 0 0
Saga
Country [82] 0 0
Japan
State/province [82] 0 0
Saitama
Country [83] 0 0
Japan
State/province [83] 0 0
Shimane
Country [84] 0 0
Japan
State/province [84] 0 0
Shizuoka
Country [85] 0 0
Japan
State/province [85] 0 0
Tokyo
Country [86] 0 0
Japan
State/province [86] 0 0
Toyama
Country [87] 0 0
Japan
State/province [87] 0 0
Yamagata
Country [88] 0 0
Japan
State/province [88] 0 0
Yamaguchi
Country [89] 0 0
Japan
State/province [89] 0 0
Yamanashi
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Busan
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Cheongju-si, Chungcheongbuk-do
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Daegu
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Daejon
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Gwangju
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Seoul
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Suwon-si, Gyeonggi-do
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Wonju-si, Kanwon-do
Country [98] 0 0
Netherlands
State/province [98] 0 0
Alkmaar
Country [99] 0 0
Netherlands
State/province [99] 0 0
Almere
Country [100] 0 0
Netherlands
State/province [100] 0 0
Beek
Country [101] 0 0
Netherlands
State/province [101] 0 0
Breda
Country [102] 0 0
Netherlands
State/province [102] 0 0
Eindhoven
Country [103] 0 0
Netherlands
State/province [103] 0 0
Hengelo
Country [104] 0 0
Netherlands
State/province [104] 0 0
Leiden
Country [105] 0 0
Netherlands
State/province [105] 0 0
Rotterdam
Country [106] 0 0
Netherlands
State/province [106] 0 0
Utrecht
Country [107] 0 0
Poland
State/province [107] 0 0
Bialystok
Country [108] 0 0
Poland
State/province [108] 0 0
Bydgoszcz
Country [109] 0 0
Poland
State/province [109] 0 0
Grudziadz
Country [110] 0 0
Poland
State/province [110] 0 0
Koscian
Country [111] 0 0
Poland
State/province [111] 0 0
Krakow
Country [112] 0 0
Poland
State/province [112] 0 0
Lodz
Country [113] 0 0
Poland
State/province [113] 0 0
Lublin
Country [114] 0 0
Poland
State/province [114] 0 0
Ostrowiec Swietokrzyski
Country [115] 0 0
Poland
State/province [115] 0 0
Poznan
Country [116] 0 0
Poland
State/province [116] 0 0
Rzeszow
Country [117] 0 0
Poland
State/province [117] 0 0
Slupsk
Country [118] 0 0
Poland
State/province [118] 0 0
Sopot
Country [119] 0 0
Poland
State/province [119] 0 0
Szczecin
Country [120] 0 0
Poland
State/province [120] 0 0
Tarnow
Country [121] 0 0
Poland
State/province [121] 0 0
Zgierz
Country [122] 0 0
Romania
State/province [122] 0 0
Bacau
Country [123] 0 0
Romania
State/province [123] 0 0
Brasov
Country [124] 0 0
Romania
State/province [124] 0 0
Bucharest
Country [125] 0 0
Romania
State/province [125] 0 0
Bucuresti
Country [126] 0 0
Romania
State/province [126] 0 0
Cluj Napoca
Country [127] 0 0
Romania
State/province [127] 0 0
Craiova
Country [128] 0 0
Romania
State/province [128] 0 0
Deva
Country [129] 0 0
Romania
State/province [129] 0 0
Galati
Country [130] 0 0
Romania
State/province [130] 0 0
Iasi
Country [131] 0 0
Romania
State/province [131] 0 0
Oradea
Country [132] 0 0
Romania
State/province [132] 0 0
Pitesti
Country [133] 0 0
Romania
State/province [133] 0 0
Slobozia
Country [134] 0 0
Romania
State/province [134] 0 0
Suceava
Country [135] 0 0
Romania
State/province [135] 0 0
Targu Mures
Country [136] 0 0
Romania
State/province [136] 0 0
Timisoara
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Arkhangelsk
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Belgorod
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Blagoveshchensk
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Chelyabinsk
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Chita
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Ekaterinburg
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Irkutsk
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Ivanovo
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Izhevsk
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Kazan
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Kemerovo
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Khantymansiysk
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Krasnodar
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Krasnoyarsk
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Moscow
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Orenburg
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Perm
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Petrozavodsk
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Saint Petersburg
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Saint-Petersburg
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Samara
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Saratov
Country [159] 0 0
Russian Federation
State/province [159] 0 0
St Petersburg
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Tomsk
Country [161] 0 0
Russian Federation
State/province [161] 0 0
Tver
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Ufa
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Ulan-Ude
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Ulyanovsk
Country [165] 0 0
Russian Federation
State/province [165] 0 0
Yaroslavl
Country [166] 0 0
South Africa
State/province [166] 0 0
Mpumalanga
Country [167] 0 0
South Africa
State/province [167] 0 0
Bellville
Country [168] 0 0
South Africa
State/province [168] 0 0
Bloemfontein
Country [169] 0 0
South Africa
State/province [169] 0 0
Cape Town
Country [170] 0 0
South Africa
State/province [170] 0 0
Durban
Country [171] 0 0
South Africa
State/province [171] 0 0
Mowbray
Country [172] 0 0
South Africa
State/province [172] 0 0
Panorama
Country [173] 0 0
South Africa
State/province [173] 0 0
Pretoria West
Country [174] 0 0
South Africa
State/province [174] 0 0
Reiger Park
Country [175] 0 0
South Africa
State/province [175] 0 0
Somerset West
Country [176] 0 0
South Africa
State/province [176] 0 0
Tygerberg
Country [177] 0 0
Spain
State/province [177] 0 0
Madrid
Country [178] 0 0
Spain
State/province [178] 0 0
Badalona
Country [179] 0 0
Spain
State/province [179] 0 0
Barcelona
Country [180] 0 0
Spain
State/province [180] 0 0
Burgos
Country [181] 0 0
Spain
State/province [181] 0 0
Centelles
Country [182] 0 0
Spain
State/province [182] 0 0
Gerona
Country [183] 0 0
Spain
State/province [183] 0 0
Hospitalet de Llobregat
Country [184] 0 0
Spain
State/province [184] 0 0
Las Palmas
Country [185] 0 0
Spain
State/province [185] 0 0
Loja/ Granada
Country [186] 0 0
Spain
State/province [186] 0 0
Pozuelo De Alarcón/Madrid
Country [187] 0 0
Spain
State/province [187] 0 0
Salamanca
Country [188] 0 0
Spain
State/province [188] 0 0
Santander
Country [189] 0 0
Spain
State/province [189] 0 0
Santiago de Compostela
Country [190] 0 0
Spain
State/province [190] 0 0
Valladolid
Country [191] 0 0
Spain
State/province [191] 0 0
Zaragoza
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Aberdeenshire
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Essex
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Lanarkshire
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Lancashire
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Middlesex
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Northamptonshire
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Sussex East
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Bradford
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Edgbaston
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Liverpool.
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Sidcup, Kent
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Trowbridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study is available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/Posting.aspx?ID=20767


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02924688