An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma

NCT02301975 | Completed Phase 3 Results

• 1 other identifier: 201378
• Study Type: interventional
• Target: 1,526
• Locations: 12 countries
• Sites: 179

Brief Summary

This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate \[FP\]/salmeterol 250/50 microgram \[mcg\]twice daily \[BD\]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA. SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.

Conditions

Asthma

Keywords

Adult; asthma; Fluticasone Propionate; Adolescents; Salmeterol; Vilanterol; ELLIPTA; ACCUHALER/DISKUS; Non-inferior; Fluticasone Furoate

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population

  FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication.

  Baseline and Week 24

• Change From Baseline in PM FEV1 Using Per Protocol (PP) Population

  FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the MMRM models and least square mean and standard error were calculated. The analysis was performed on PP Population which comprised of all participants in the ITT Population who did not had any full protocol deviations.

  Baseline and Week 24

Secondary Outcomes (5)

• Change From Baseline in the Percentage of Rescue-free 24-hour Periods

  Baseline and Weeks 1-24

• Change From Baseline in the Percentage of Symptom-free 24-hour Periods

  Baseline and Weeks 1-24

• Change From Baseline in Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF)

  Baseline and Weeks 1-24

• Percentage of Participants With Asthma Control Test (ACT) Score Greater Than or Equal to 20

  Week 24

• Change From Baseline in PM PEF

  Baseline and Weeks 1-24

Study Arms (3)

Fluticasone Furoate/Vilanterol 100/25 mcg

EXPERIMENTAL

FF/VI 100/25 mcg by inhalation OD (PM) via ELLIPTA plus placebo by inhalation BD (AM and PM) via ACCUHALER/DISKUS for 24 weeks.

Drug: Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler; Drug: Placebo inhalation powder via ACCUHALER/DISKUS inhaler

Fluticasone Propionate/Salmeterol 250/50 mcg

EXPERIMENTAL

FP/Salmeterol 250/50 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.

Drug: Placebo inhalation powders via ELLIPTA inhaler; Drug: Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler

Fluticasone Propionate 250 mcg

EXPERIMENTAL

FP 250 mcg by inhalation BD (AM and PM) via ACCUHALER/DISKUS plus placebo by inhalation OD (PM) via ELLIPTA for 24 weeks.

Drug: Placebo inhalation powders via ELLIPTA inhaler; Drug: Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler

Interventions

Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler DRUG

FF/Vilanterol 100/25 mcg inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device and 100/25 mcg per actuation.

Fluticasone Furoate/Vilanterol 100/25 mcg

Placebo inhalation powders via ELLIPTA inhaler DRUG

Placebo inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device.

Fluticasone Propionate 250 mcg; Fluticasone Propionate/Salmeterol 250/50 mcg

Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler DRUG

FP/Salmeterol 250/50 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250/50 mcg per actuation.

Fluticasone Propionate/Salmeterol 250/50 mcg

Placebo inhalation powder via ACCUHALER/DISKUS inhaler DRUG

Placebo inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device.

Fluticasone Furoate/Vilanterol 100/25 mcg

Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler DRUG

FP 250 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250 mcg per actuation.

Fluticasone Propionate 250 mcg

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities.
• Subjects must be outpatients \>=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to Visit 1 (Note: Countries with local restrictions prohibiting enrollment of adolescents will enroll subjects \>=18 years of age only).
• Subjects may be male or an eligible female. An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at Screening and agrees to use an acceptable method of birth control consistently and correctly.
• Subjects must have a FEV1 of \>=80% of the predicted normal value.
• Subjects are eligible if they have received mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1.
• All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use, as needed, for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits.

You may not qualify if:

• History of Life-Threatening Asthma, defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years.
• Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or in the opinion of the Investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study.
• Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
• A subject must not have current evidence of Atlectasis, Bronchopulmonary dysplasia, Chronic bronchitis, Chronic obstructive pulmonary disease, Pneumonia, Pneumothorax, Interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma
• A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
• A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study, whichever is longer of the two.
• Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of RELVAR™ ELLIPTA inhaler, SERETIDE™ ACCUHALER/DISKUS inhaler or FP 250.
• History of severe milk protein allergy.
• Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug.
• A subject must not be using or require the use of immunosuppressive medications during the study.
• A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries.
• Current tobacco smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products or inhaled marijuana within the past 3 months (e.g., cigarettes, cigars, electronic cigarettes, or pipe tobacco).
• A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (179)

GSK Investigational Site

Huntington Beach, California, 92647, United States

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GSK Investigational Site

Riverside, California, 92506, United States

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GSK Investigational Site

Rolling Hills Estates, California, 90274, United States

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GSK Investigational Site

San Diego, California, 92103, United States

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GSK Investigational Site

Upland, California, 91786, United States

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GSK Investigational Site

Denver, Colorado, 80230, United States

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GSK Investigational Site

Miami, Florida, 33165, United States

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GSK Investigational Site

Miami, Florida, 33174, United States

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GSK Investigational Site

Albany, Georgia, 31707, United States

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GSK Investigational Site

Baltimore, Maryland, 21236, United States

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GSK Investigational Site

Columbia, Maryland, 21044, United States

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GSK Investigational Site

Minneapolis, Minnesota, 55402, United States

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GSK Investigational Site

Plymouth, Minnesota, 55441, United States

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GSK Investigational Site

Columbia, Missouri, 65203, United States

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GSK Investigational Site

Rolla, Missouri, 65401, United States

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GSK Investigational Site

Bellevue, Nebraska, 68123-4303, United States

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GSK Investigational Site

Charlotte, North Carolina, 28277, United States

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GSK Investigational Site

Gastonia, North Carolina, 28054, United States

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GSK Investigational Site

Hendersonville, North Carolina, 28739, United States

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GSK Investigational Site

Huntersville, North Carolina, 28078, United States

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GSK Investigational Site

Canton, Ohio, 44718, United States

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GSK Investigational Site

Cincinnati, Ohio, 45231, United States

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GSK Investigational Site

Middleburg Heights, Ohio, 44130, United States

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GSK Investigational Site

Medford, Oregon, 97504, United States

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GSK Investigational Site

Bethlehem, Pennsylvania, 18020, United States

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GSK Investigational Site

Greenville, South Carolina, 29615, United States

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GSK Investigational Site

Orangeburg, South Carolina, 29118, United States

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Rock Hill, South Carolina, 29732, United States

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Spartanburg, South Carolina, 29303, United States

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Austin, Texas, 78750, United States

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Lewisville, Texas, 75067, United States

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Waco, Texas, 76712, United States

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Richmond, Virginia, 23225, United States

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Greenfield, Wisconsin, 53228, United States

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Florida, Buenos Aires, 1602, Argentina

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La Plata, Buenos Aires, 1900, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Quilmes, Buenos Aires, B1878FNR, Argentina

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Rosario, Santa Fe Province, S2000DBS, Argentina

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Rosario, Santa Fe Province, S2000JKR, Argentina

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GSK Investigational Site

Buenos Aires, C1121ABE, Argentina

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Buenos Aires, C1424BSF, Argentina

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GSK Investigational Site

Buenos Aires, C1425BEN, Argentina

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Buenos Aires, C1426ABP, Argentina

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Mar del Plata, B7600FYK, Argentina

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Mendoza, 5500, Argentina

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Mendoza, M5500CCG, Argentina

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GSK Investigational Site

San Miguel de Tucumán, 4000, Argentina

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Salvador, Estado de Bahia, 41940455, Brazil

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GSK Investigational Site

Goiânia, Goiás, 74110 030, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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São Paulo, 01323903, Brazil

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São Paulo, 04266-010, Brazil

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Valparaíso, Región de Valparaíso, 2341131, Chile

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GSK Investigational Site

Concepción, Región Del Biobio, 4070038, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, 7500692, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, 7500710, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, 7510186, Chile

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Santiago, 7500698, Chile

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GSK Investigational Site

Viña del Mar, 2520594, Chile

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GSK Investigational Site

Česká Lípa, 470 01, Czechia

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GSK Investigational Site

Hlučín, 748 01, Czechia

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GSK Investigational Site

Hradec Králové, 500 02, Czechia

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GSK Investigational Site

Kutná Hora, 284 01, Czechia

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GSK Investigational Site

Lovosice, 410 02, Czechia

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GSK Investigational Site

Olomouc, 772 00, Czechia

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GSK Investigational Site

Ostrava - Poruba, 70868, Czechia

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GSK Investigational Site

Rokycany, 337 01, Czechia

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GSK Investigational Site

Tábor, 390 01, Czechia

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GSK Investigational Site

Teplice, 415 10, Czechia

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GSK Investigational Site

Varnsdorf, 407 47, Czechia

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GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70378, Germany

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Bamberg, Bavaria, 96049, Germany

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GSK Investigational Site

Munich, Bavaria, 80339, Germany

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GSK Investigational Site

Munich, Bavaria, 80539, Germany

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GSK Investigational Site

Potsdam, Brandenburg, 14469, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60389, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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GSK Investigational Site

Marburg, Hesse, 35037, Germany

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GSK Investigational Site

Neu-Isenburg, Hesse, 63263, Germany

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GSK Investigational Site

Hanover, Lower Saxony, 30173, Germany

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GSK Investigational Site

Peine, Lower Saxony, 31224, Germany

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GSK Investigational Site

Essen, North Rhine-Westphalia, 45355, Germany

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GSK Investigational Site

Essen, North Rhine-Westphalia, 45359, Germany

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GSK Investigational Site

Warendorf, North Rhine-Westphalia, 48231, Germany

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GSK Investigational Site

Witten, North Rhine-Westphalia, 58452, Germany

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GSK Investigational Site

Koblenz, Rhineland-Palatinate, 56068, Germany

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GSK Investigational Site

Delitzsch, Saxony, 04509, Germany

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GSK Investigational Site

Leipzg, Saxony, 04109, Germany

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GSK Investigational Site

Leipzig, Saxony, 04207, Germany

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GSK Investigational Site

Leipzig, Saxony, 04275, Germany

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GSK Investigational Site

Leipzig, Saxony, 04357, Germany

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GSK Investigational Site

Teuchern, Saxony-Anhalt, 6682, Germany

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GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

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GSK Investigational Site

Lübeck, Schleswig-Holstein, 23552, Germany

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GSK Investigational Site

Schleswig, Schleswig-Holstein, 24837, Germany

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GSK Investigational Site

Schmölln, Thuringia, 04626, Germany

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GSK Investigational Site

Berlin, 10119, Germany

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Berlin, 10367, Germany

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GSK Investigational Site

Berlin, 10717, Germany

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GSK Investigational Site

Berlin, 10787, Germany

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GSK Investigational Site

Berlin, 10969, Germany

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Berlin, 12203, Germany

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Berlin, 13156, Germany

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GSK Investigational Site

Hamburg, 22299, Germany

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GSK Investigational Site

Zapopan, Jalisco, 45030, Mexico

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GSK Investigational Site

Zapopan, Jalisco, 45070, Mexico

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GSK Investigational Site

Morelia, Michoacán, 58070, Mexico

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GSK Investigational Site

Monterrey NL, Nuevo León, 64718, Mexico

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GSK Investigational Site

Villahermosa, Tabasco, 86035, Mexico

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Mexico City, 01710, Mexico

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GSK Investigational Site

Almelo, 7609 PP, Netherlands

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Almere Stad, 1311 RL, Netherlands

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GSK Investigational Site

Almere Stad, 1315 RC, Netherlands

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GSK Investigational Site

Breda, 4818 CK, Netherlands

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GSK Investigational Site

Breda, 4819 EV, Netherlands

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GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

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Harderwijk, 3844 DG, Netherlands

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Hoorn, 1624 NP, Netherlands

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GSK Investigational Site

Kloosterhaar, 7694 AC, Netherlands

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Nijverdal, 7442 LS, Netherlands

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GSK Investigational Site

Zutphen, 7207 AE, Netherlands

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GSK Investigational Site

Bacau, 600114, Romania

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GSK Investigational Site

Bacau, 600252, Romania

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GSK Investigational Site

Brasov, 500112, Romania

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GSK Investigational Site

Bucharest, 020125, Romania

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GSK Investigational Site

Bucharest, 022102, Romania

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GSK Investigational Site

Bucharest, 030317, Romania

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GSK Investigational Site

Bucharest, 050159, Romania

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GSK Investigational Site

Cluj-Napoca, 400371, Romania

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GSK Investigational Site

Codlea, 505100, Romania

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GSK Investigational Site

Craiova, 200345, Romania

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GSK Investigational Site

Deva, 330182, Romania

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GSK Investigational Site

Piteşti, 110084, Romania

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Suceava, 720284, Romania

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GSK Investigational Site

Timișoara, 300310, Romania

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GSK Investigational Site

Barnaul, 656 045, Russia

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GSK Investigational Site

Blagoveshchensk, 675000, Russia

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Irkutsk, 664043, Russia

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GSK Investigational Site

Kemerovo, 650000, Russia

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GSK Investigational Site

Kemerovo, 650002, Russia

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GSK Investigational Site

Krasnodar, 350012, Russia

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GSK Investigational Site

Moscow, 115201, Russia

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GSK Investigational Site

Moscow, 115478, Russia

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GSK Investigational Site

Moscow, 123 182, Russia

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GSK Investigational Site

Moscow, 125315, Russia

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Omsk, 644112, Russia

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Pyatigorsk, 357538, Russia

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GSK Investigational Site

Saint Petersburg, 194354, Russia

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GSK Investigational Site

Saint Petersburg, 194356, Russia

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GSK Investigational Site

Saint Petersburg, 196240, Russia

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GSK Investigational Site

Saint Petesburg, 195030, Russia

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GSK Investigational Site

Saratov, 410028, Russia

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GSK Investigational Site

St'Petersburg, 197706, Russia

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GSK Investigational Site

Stavropol, 355017, Russia

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GSK Investigational Site

Tomsk, 634009, Russia

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GSK Investigational Site

Tomsk, 634033, Russia

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GSK Investigational Site

Ufa, 450071, Russia

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GSK Investigational Site

Ulyanovsk, 432063, Russia

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GSK Investigational Site

Vladimir, 600023, Russia

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GSK Investigational Site

Volgodonsk, 347381, Russia

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GSK Investigational Site

Voronezh, 394018, Russia

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GSK Investigational Site

Cheongju-si, Chungcheongbuk-do, 361-763, South Korea

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GSK Investigational Site

Incheon, 403-720, South Korea

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GSK Investigational Site

Seoul, 110-744, South Korea

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GSK Investigational Site

Seoul, 135-710, South Korea

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GSK Investigational Site

Seoul, 138-736, South Korea

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GSK Investigational Site

Suwon-si, Gyeonggi-do, 16499, South Korea

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GSK Investigational Site

Alicante, 03004, Spain

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GSK Investigational Site

Alzira/Valencia, 46600, Spain

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GSK Investigational Site

Badalona, 08916, Spain

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GSK Investigational Site

Barcelona, 08016, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Centelles (Barcelona), 08540, Spain

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GSK Investigational Site

Madrid, 28009, Spain

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GSK Investigational Site

Pozuelo de Alarcón/Madrid, 28223, Spain

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GSK Investigational Site

Santander, 39008, Spain

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GSK Investigational Site

Santiago de Compostela, 15706, Spain

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GSK Investigational Site

Valencia, 46015, Spain

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Related Publications (2)

• Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

  PMID: 36472162 DERIVED

• Bernstein D, Andersen L, Forth R, Jacques L, Yates L. Once-daily fluticasone furoate/vilanterol versus twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA. J Asthma. 2018 Sep;55(9):984-993. doi: 10.1080/02770903.2017.1386214. Epub 2018 Apr 13.

  PMID: 28961020 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate; vilanterol; Fluticasone; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: March 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 25, 2016
• Last Updated: August 6, 2018
• Results First Posted: June 12, 2017

Record last verified: 2018-08

Locations

CZ (11); ES (11); RU (26); CL (7); NL (11); ME (6); KR (6); US (34); AR (14); DE (34); RO (14); BR (5)