An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma.

A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, and Fluticasone Furoate 100 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents

This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Fluticasone Furoate/ Vilanterol 200/25 mcg; Drug: Fluticasone Furoate/ Vilanterol 100/25 mcg; Drug: Fluticasone Furoate 100 mcg

• Study Type: Interventional
• Enrollment (Actual): 1040
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Berazategui, Argentina, 1886
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1424BSF
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1425BEN
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1425FVH
    • GSK Investigational Site
  • Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
    • GSK Investigational Site
  • Mendoza, Argentina, M5500CCG
    • GSK Investigational Site
  • Mendoza, Argentina, 5500
    • GSK Investigational Site
  • San Miguel de Tucumán, Argentina, 4000
    • GSK Investigational Site
  • Tucuman, Argentina, 4000
    • GSK Investigational Site
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH
      • GSK Investigational Site
    • Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
      • GSK Investigational Site
  • Mendoza
    • San Rafael, Mendoza, Argentina, 5600
      • GSK Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000JKR
      • GSK Investigational Site
• Chile
  • Santiago, Chile, 8380453
    • GSK Investigational Site
  • Reg Del Libert Bern Ohiggins
    • Rancagua, Reg Del Libert Bern Ohiggins, Chile, 2841959
      • GSK Investigational Site
  • Región Metro De Santiago
    • Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
      • GSK Investigational Site
    • Santiago, Región Metro De Santiago, Chile, 7500800
      • GSK Investigational Site
  • Valparaíso
    • Quillota, Valparaíso, Chile, 2260000
      • GSK Investigational Site
    • Valparaiso, Valparaíso, Chile, 2341131
      • GSK Investigational Site
    • Viña del Mar, Valparaíso, Chile
      • GSK Investigational Site
• Germany
  • Berlin, Germany, 13086
    • GSK Investigational Site
  • Berlin, Germany, 10717
    • GSK Investigational Site
  • Berlin, Germany, 14050
    • GSK Investigational Site
  • Berlin, Germany, 10787
    • GSK Investigational Site
  • Berlin, Germany, 12203
    • GSK Investigational Site
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14467
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
      • GSK Investigational Site
    • Frankfurt, Hessen, Germany, 60389
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Koblenz, Rheinland-Pfalz, Germany, 56068
      • GSK Investigational Site
  • Sachsen
    • Leipzg, Sachsen, Germany, 04109
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39112
      • GSK Investigational Site
  • Schleswig-Holstein
    • Grosshansdorf, Schleswig-Holstein, Germany, 22927
      • GSK Investigational Site
• Mexico
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45040
      • GSK Investigational Site
  • Michoacán
    • Morelia, Michoacán, Mexico, 58070
      • GSK Investigational Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64000
      • GSK Investigational Site
  • Tabasco
    • Villahermosa, Tabasco, Mexico, 86100
      • GSK Investigational Site
• Netherlands
  • Almelo, Netherlands, 7609 PP
    • GSK Investigational Site
  • Breda, Netherlands, 4819 EV
    • GSK Investigational Site
  • Eindhoven, Netherlands, 5623 EJ
    • GSK Investigational Site
  • Enschede, Netherlands, 7513 ER
    • GSK Investigational Site
  • Hoorn, Netherlands, 1624 NP
    • GSK Investigational Site
  • Veldhoven, Netherlands, 5504 DB
    • GSK Investigational Site
  • Zutphen, Netherlands, 7207 AE
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-027
    • GSK Investigational Site
  • Krakow, Poland, 31-024
    • GSK Investigational Site
  • Krakow, Poland, 31-455
    • GSK Investigational Site
  • Krakow, Poland, 30-901
    • GSK Investigational Site
  • Lodz, Poland, 90-242
    • GSK Investigational Site
  • Tarnow, Poland, 33-100
    • GSK Investigational Site
  • Warszawa, Poland, 02-507
    • GSK Investigational Site
  • Wroclaw, Poland, 53-301
    • GSK Investigational Site
• Romania
  • Bacau, Romania, 600114
    • GSK Investigational Site
  • Brasov, Romania, 500112
    • GSK Investigational Site
  • Bucharest, Romania, 020125
    • GSK Investigational Site
  • Bucharest, Romania, 030317
    • GSK Investigational Site
  • Bucuresti, Romania, 022102
    • GSK Investigational Site
  • Cluj Napoca, Romania, 400370
    • GSK Investigational Site
  • Craiova, Romania, 200642
    • GSK Investigational Site
  • Deva, Romania, 330084
    • GSK Investigational Site
  • Iasi, Romania, 700115
    • GSK Investigational Site
  • Pitesti, Romania, 110084
    • GSK Investigational Site
  • Ploiesti, Romania, 100172
    • GSK Investigational Site
  • Ploiesti, Romania, 100184
    • GSK Investigational Site
  • Timisoara, Romania, 300310
    • GSK Investigational Site
• Russian Federation
  • Blagoveshchensk, Russian Federation, 675000
    • GSK Investigational Site
  • Chelyabinsk, Russian Federation, 454021
    • GSK Investigational Site
  • Chita, Russian Federation, 672090
    • GSK Investigational Site
  • Ekaterinburg, Russian Federation, 620109
    • GSK Investigational Site
  • Ivanovo, Russian Federation, 153005
    • GSK Investigational Site
  • Kazan, Russian Federation, 420015
    • GSK Investigational Site
  • Moscow, Russian Federation, 123182
    • GSK Investigational Site
  • Moscow, Russian Federation, 115446
    • GSK Investigational Site
  • Moscow, Russian Federation, 123367
    • GSK Investigational Site
  • Nizhniy Novgorod, Russian Federation, 603126
    • GSK Investigational Site
  • Pyatigorsk, Russian Federation, 357538
    • GSK Investigational Site
  • Ryazan, Russian Federation, 390039
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 194356
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 197022
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 194291
    • GSK Investigational Site
  • Stavropol, Russian Federation, 355030
    • GSK Investigational Site
  • Tomsk, Russian Federation, 634 050
    • GSK Investigational Site
  • Vladivostok, Russian Federation, 690950
    • GSK Investigational Site
  • Voronezh, Russian Federation, 394066
    • GSK Investigational Site
• Sweden
  • Göteborg, Sweden, SE-413 90
    • GSK Investigational Site
  • Linköping, Sweden, SE-582 16
    • GSK Investigational Site
  • Luleå, Sweden, SE-971 89
    • GSK Investigational Site
  • Lund, Sweden, SE-221 85
    • GSK Investigational Site
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site
• Ukraine
  • Dnipropetrovsk, Ukraine, 49051
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61124
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61002
    • GSK Investigational Site
  • Kiev, Ukraine, 03680
    • GSK Investigational Site
  • Kyiv, Ukraine, 03680
    • GSK Investigational Site
  • Kyiv, Ukraine, 04201
    • GSK Investigational Site
  • Poltava, Ukraine, 36024
    • GSK Investigational Site
  • Vinnytsia, Ukraine, 21018
    • GSK Investigational Site
  • Vinnytsia, Ukraine, 21029
    • GSK Investigational Site
  • Zaporizhia, Ukraine, 69035
    • GSK Investigational Site
  • Zaporizhia, Ukraine, 69063
    • GSK Investigational Site
  • Zaporizhia, Ukraine, 69076
    • GSK Investigational Site
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • Huntington Beach, California, United States, 92647
      • GSK Investigational Site
    • Los Angeles, California, United States, 90025
      • GSK Investigational Site
    • Newport Beach, California, United States, 92663
      • GSK Investigational Site
    • Rancho Mirage, California, United States, 92270
      • GSK Investigational Site
    • Rolling Hills Estates, California, United States, 90274
      • GSK Investigational Site
    • San Diego, California, United States, 92103-8415
      • GSK Investigational Site
    • Vista, California, United States, 92083
      • GSK Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • GSK Investigational Site
    • Denver, Colorado, United States, 80206
      • GSK Investigational Site
    • Wheat Ridge, Colorado, United States, 80033
      • GSK Investigational Site
  • Florida
    • Tallahassee, Florida, United States, 32308
      • GSK Investigational Site
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • GSK Investigational Site
  • Illinois
    • Normal, Illinois, United States, 61761
      • GSK Investigational Site
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • GSK Investigational Site
    • Columbia, Maryland, United States, 21044
      • GSK Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • GSK Investigational Site
  • Missouri
    • Rolla, Missouri, United States, 65401
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63143
      • GSK Investigational Site
  • New Jersey
    • Skillman, New Jersey, United States, 08558
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27607
      • GSK Investigational Site
    • Shelby, North Carolina, United States, 28152
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • GSK Investigational Site
    • Cincinnati, Ohio, United States, 45242
      • GSK Investigational Site
    • Middleburg Heights, Ohio, United States, 44130
      • GSK Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • GSK Investigational Site
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • GSK Investigational Site
    • Fort Mill, South Carolina, United States, 29707
      • GSK Investigational Site
    • Greenville, South Carolina, United States, 29615
      • GSK Investigational Site
    • Orangeburg, South Carolina, United States, 29118
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
  • Texas
    • El Paso, Texas, United States, 79903
      • GSK Investigational Site
    • Waco, Texas, United States, 76712
      • GSK Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23219
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98122
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must give their signed and dated (written) informed consent to participate. Written informed consent must be obtained if a subject's current medication is changed as a result of study participation
• Outpatient >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health. Countries with local restrictions prohibiting enrolment of adolescents will only enroll subjects >=18 years of age
• Male or an eligible female. Eligible female is defined as having non-childbearing potential or having childbearing potential and using an acceptable method of birth control consistently and correctly.
• Best pre-bronchodilator FEV1 of 40% to 80% of their predicted normal value.
• Demonstrate >=12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or an equivalent nebulized treatment with albuterol/salbutamol solution) or have documented reversibility testing within the 6 months prior to Visit 1 meeting this measure of reversibility. A spacer device may be used for testing, if required.
• If subject have received ICS for at least 12 weeks prior to Visit 1 and their treatment during the 4 weeks immediately prior to Visit 1 consisted of either of the two regimens (a or b).a.) A stable mid-dose or high-dose of ICS alone (e.g., >=FP 250 mcg twice daily) or b.) A stable dose of a mid-dose ICS/LABA combination (e.g., FP/Salmeterol [SALM] 250/50 mcg twice daily) or an equivalent combination via separate inhalers.
• Use of ICS/LABA are not permitted with LABA on the day of Visit 1.
• Must be able to replace current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, during the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits

Exclusion Criteria:

• History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years.
• 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 that required oral corticosteroids within the 12 weeks prior to Visit 1 or, resulted in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
• A subject must not have current evidence of atelectasis (segmental or larger), bronchopulmonary dysplasia, chronic obstructive pulmonary 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 efficacy results if the condition/disease exacerbated during the study
• Chronic stable hepatitis B or C are acceptable provided their screening alanine transaminase (ALT) is <2x upper limit of normal (ULN) and the y otherwise meet the entry criteria. Chronic co-infection with both hepatitis B and hepatitis C are not eligible
• Clinical visual evidence of candidiasis at Visit 1
• Use of any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½), whichever is longer of the two.
• Allergies to drug or milk protein: any adverse reaction, to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy or known or suspected sensitivity to the constituents of the NDPI, or history of severe milk protein allergy
• Administration of medication that would significantly affect the course of asthma, or interact with study drug
• Use of immunosuppressive medications during the study.
• Use of potent CYP3A4 inhibitor within 4 weeks of Visit 1.
• A subject or his/her parent or legal guardian has any infirmity, disability, disease, or resides in a 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 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 within the past 3 months (i.e., cigarettes, cigars, or pipe tobacco).
• If subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
• Subject previously randomized to treatment with FF/VI or FF in another Phase III study
• Subjects working on night shift a week prior to Visit 1 or during the study period.
• Adolescents who are wards of the state or government

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm1: Fluticasone Furoate/ Vilanterol 200/25 mcg; At Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (<=65% or >65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF/ VI 200/25 mcg once daily in the evening for 84 days.	Drug: Fluticasone Furoate/ Vilanterol 200/25 mcg; Fluticasone furoate/ vilanterol will be available as 200/25 mcg Novel dry powder inhaler (NDPI) with 30 doses per device and 200/25 mcg per actuation
EXPERIMENTAL: Arm 2: Fluticasone Furoate/ Vilanterol 100/25 mcg; At Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (<=65% or >65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF/ VI 100/25 mcg once daily in the evening for 84 days	Drug: Fluticasone Furoate/ Vilanterol 100/25 mcg; Fluticasone furoate/ vilanterol will be available as 100/25 mcg NDPI with 30 doses per device and 100/25 mcg per actuation
EXPERIMENTAL: Arm 3: Fluticasone Furoate 100 mcg; At Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (<=65% or >65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF 100 mcg once daily in the evening for 84 days	Drug: Fluticasone Furoate 100 mcg; Fluticasone furoate will be available as 100 mcg NDPI with 30 doses per device and 100/25 mcg per actuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period	Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 (within 30 minutes prior to dosing) and post-dose FEV1 measurements at 5, 15, and 30 minutes and at 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours on Day 84/Week 12. At each time point, the highest of three technically acceptable measurements was recorded. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 84/Week 12 minus the Baseline value. Baseline was the pre-dose FEV1 measurement value obtained at Visit 3. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline FEV1, region, sex, age, and treatment.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period	Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on-treatment. Change from Baseline in trough FEV1 at the end of the 12-week treatment period was defined using the 24-hour post-dose serial FEV1 measurement taken at the Week 12 clinic visit. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.	Baseline and Week 12
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period	The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.	Baseline and Weeks 1-12
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period	Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.	Baseline and Weeks 1-12
Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period	Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.	Baseline and Weeks 1-12
Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period	PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.	Baseline and Weeks 1-12

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Bernstein DI, Bateman ED, Woodcock A, Toler WT, Forth R, Jacques L, Nunn C, O'Byrne PM. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. J Asthma. 2015;52(10):1073-83. doi: 10.3109/02770903.2015.1056350. Epub 2015 Aug 18.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: September 20, 2012
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 15, 2013

Study Registration Dates

• First Submitted: September 13, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (ESTIMATE): September 18, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: pharmacogenetics; adult; asthma; adolescents; fluticasone furoate; vilanterol
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: 116863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Study Protocol
   Information identifier: 116863
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: 116863
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 116863
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 116863
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 116863
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: 116863
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Annotated Case Report Form
   Information identifier: 116863
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register