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

NCT03248128 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 1071162016-004086-87
• Study Type: interventional
• Target: 906
• Locations: 16 countries
• Sites: 183

Brief Summary

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

Conditions

Asthma

Keywords

Fluticasone furoate; Efficacy; Vilanterol; Asthma; Safety; GW642444; GW685698

Outcome Measures

Primary Outcomes (2)

• Absolute Weighted Mean of Forced Expiratory Volume in 1 Second (FEV1) (0-4 Hours) at Week 12 in 5-17 Year Old Population

  Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.

  Week 12

• Change From Baseline in Mean Pre-dose Morning Peak Expiratory Flow (AM PEF) in 5-11 Year Old Population

  PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the electronic patient diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.

  Baseline and Week 1-12

Secondary Outcomes (18)

• Change From Baseline in Mean Pre-dose AM PEF Period in 5-17 Year Old Population

  Baseline and Week 1-12

• Absolute Weighted Mean of FEV1 (0-4 Hours) at Week 12 in 5-11 Year Old Population

  Week 12

• Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population

  Baseline and Week 1-12

• Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population

  Baseline and Week 1-12

• Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-17 Year Old Population

  Baseline and Week 12

Study Arms (4)

Subjects receiving FF/VI in cohort A

EXPERIMENTAL

Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 50/25 mcg administered once daily in the morning via ELLIPTA DPI.

Drug: FF/VI via ELLIPTA DPI

Subjects receiving FF in cohort A

ACTIVE COMPARATOR

Subjects will be randomized in 1:1 ratio to receive FF with a dose of 50 mcg administered once daily in the morning via ELLIPTA DPI.

Drug: FF via ELLIPTA DPI

Subjects receiving FF/VI in cohort B

EXPERIMENTAL

Subjects will be randomized in 1:1 ratio to receive a FDC of FF/VI with a dose of 100/25 mcg administered once daily in the morning via ELLIPTA DPI.

Drug: FF/VI via ELLIPTA DPI

Subjects receiving FF in cohort B

ACTIVE COMPARATOR

Subjects will be randomized in 1:1 ratio to receive FF with a dose of 100 mcg administered once daily in the morning via ELLIPTA DPI.

Drug: FF via ELLIPTA DPI

Interventions

FF/VI via ELLIPTA DPI DRUG

ELLIPTA DPI inhaler will contain two individual blister strips; the first strip will contain FF(50 or 100 mcg) and second strip will contain VI (25 mcg).

Subjects receiving FF/VI in cohort A; Subjects receiving FF/VI in cohort B

FF via ELLIPTA DPI DRUG

ELLIPTA DPI inhaler will contain a single blister strip of FF (50 or 100 mcg).

Subjects receiving FF in cohort A; Subjects receiving FF in cohort B

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (183)

GSK Investigational Site

Hoover, Alabama, 35244, United States

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GSK Investigational Site

Little Rock, Arkansas, 72205, United States

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GSK Investigational Site

Huntington Beach, California, 92648, United States

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Riverside, California, 92506, United States

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Colorado Springs, Colorado, 80907, United States

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GSK Investigational Site

Denver, Colorado, 80206, United States

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GSK Investigational Site

Denver, Colorado, 80230, United States

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Aventura, Florida, 33180, United States

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Miami, Florida, 33134, United States

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GSK Investigational Site

Miami, Florida, 33135, United States

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Miami, Florida, 33142, United States

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GSK Investigational Site

Miami, Florida, 33173, United States

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GSK Investigational Site

Miami, Florida, 33186, United States

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Miami Lakes, Florida, 33014, United States

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Ocala, Florida, 34470, United States

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Orlando, Florida, 32806, United States

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Orlando, Florida, 32827, United States

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Gainesville, Georgia, 30501, United States

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GSK Investigational Site

Savannah, Georgia, 31406, United States

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Evanston, Illinois, 60201, United States

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Oak Park, Illinois, 60301, United States

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Evansville, Indiana, 47715, United States

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Owensboro, Kentucky, 42301, United States

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Baltimore, Maryland, 21236, United States

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White Marsh, Maryland, 21162, United States

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Ypsilanti, Michigan, 48197, United States

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Piscataway, New Jersey, 08854, United States

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Verona, New Jersey, 07044, United States

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GSK Investigational Site

Great Neck, New York, 11021, United States

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GSK Investigational Site

New Hartford, New York, 13413, United States

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Asheville, North Carolina, 28801, United States

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Charlotte, North Carolina, 28277, United States

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Raleigh, North Carolina, 27607, United States

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Grove City, Ohio, 43123, United States

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Oklahoma City, Oklahoma, 73120, United States

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Medford, Oregon, 97504, United States

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Wexford, Pennsylvania, 15090, United States

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Greenville, South Carolina, 29607, United States

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Orangeburg, South Carolina, 29118-2040, United States

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Spartanburg, South Carolina, 29303, United States

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Summerville, South Carolina, 29485, United States

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Dallas, Texas, 75231-4307, United States

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Houston, Texas, 77055, United States

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Lewisville, Texas, 75067, United States

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San Antonio, Texas, 78207, United States

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San Antonio, Texas, 78215, United States

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San Antonio, Texas, 78249, United States

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Waco, Texas, 76712, United States

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Murray, Utah, 84107, United States

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Berazategui, Buenos Aires, 1837, Argentina

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CABA, Buenos Aires, C1028AAP, Argentina

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CABA, Buenos Aires, C1425BEN, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1122AAK, Argentina

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Florida, Buenos Aires, 1602, Argentina

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La Plata, Buenos Aires, 1900, Argentina

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Lanús, Buenos Aires, B1824KAJ, Argentina

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Lobos, Buenos Aires, 7240, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Nueve de Julio, Buenos Aires, B6500BWQ, Argentina

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Buenos Aires, C1121ABE, Argentina

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Buenos Aires, C1425FVH, Argentina

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Buenos Aires, C1426ABP, Argentina

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Mendoza, M5500CCG, Argentina

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Rosario, S2000BRH, Argentina

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Santa Fe, 3000, Argentina

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Rousse, 7002, Bulgaria

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Sofia, 1510, Bulgaria

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Sofia, 1784, Bulgaria

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Stara Zagora, 5400, Bulgaria

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Brampton, Ontario, L6T 0G1, Canada

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Windsor, Ontario, N8X2G1, Canada

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Québec, G1V 4W2, Canada

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Panzhihua, Sichuan, 617023, China

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Taiyuan, 030013, China

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Heidelberg, Baden-Wurttemberg, 69126, Germany

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Mannheim, Baden-Wurttemberg, 68161, Germany

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Rosenheim, Bavaria, 83026, Germany

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GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

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GSK Investigational Site

Budapest, 1083, Hungary

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Budapest, 1089, Hungary

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Szeged, H-6720, Hungary

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GSK Investigational Site

Parma, Emilia-Romagna, 43126, Italy

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Rome, Lazio, 00165, Italy

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Bergamo, Lombardy, 24127, Italy

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GSK Investigational Site

Milan, Lombardy, 20122, Italy

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Milan, Lombardy, 20154, Italy

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GSK Investigational Site

Palermo, Sicily, 9000, Italy

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GSK Investigational Site

Ancona, The Marches, 60123, Italy

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GSK Investigational Site

Perugia, Umbria, 06156, Italy

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GSK Investigational Site

Chiba, 260-0001, Japan

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GSK Investigational Site

Fukui, 918-8205, Japan

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GSK Investigational Site

Fukuoka, 811-1394, Japan

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GSK Investigational Site

Fukuoka, 813-0017, Japan

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GSK Investigational Site

Hiroshima, 721-8511, Japan

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GSK Investigational Site

Hokkaido, 040-8585, Japan

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GSK Investigational Site

Hokkaido, 040-8611, Japan

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GSK Investigational Site

Hyōgo, 653-0836, Japan

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Kanagawa, 223-0059, Japan

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Osaka, 583-8588, Japan

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GSK Investigational Site

Tokyo, 104-0031, Japan

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Tokyo, 154-0017, Japan

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GSK Investigational Site

Tokyo, 157-0066, Japan

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GSK Investigational Site

Tokyo, 158-0097, Japan

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GSK Investigational Site

Tokyo, 171-0014, Japan

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GSK Investigational Site

Tokyo, 176-0012, Japan

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GSK Investigational Site

Vilnius, 9108, Lithuania

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GSK Investigational Site

Guadalajara, Jalisco, 44100, Mexico

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GSK Investigational Site

Guadalajara, Jalisco, 44670, Mexico

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Zapopan, Jalisco, 45070, Mexico

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Monterrey, Nuevo León, 64000, Mexico

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Monterrey, Nuevo León, 64710, Mexico

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GSK Investigational Site

Villahermosa, Tabasco, 86035, Mexico

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GSK Investigational Site

Bialystok, 15-430, Poland

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GSK Investigational Site

Bialystok, 15879, Poland

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GSK Investigational Site

Bydgoszcz, 85-796, Poland

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GSK Investigational Site

Częstochowa, 42-200, Poland

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Katowice, 40-040, Poland

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Krakow, 31-011, Poland

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Lodz, 90-153, Poland

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GSK Investigational Site

Lodz, 90-329, Poland

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GSK Investigational Site

Ostrowiec Świętokrzyski, 27-400, Poland

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GSK Investigational Site

Ostrów Wielkopolski, 63-400, Poland

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GSK Investigational Site

Poznan, 60-693, Poland

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GSK Investigational Site

Skierniewice, 96-100, Poland

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GSK Investigational Site

Strzelce Opolskie, 47-100, Poland

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GSK Investigational Site

Tarnów, 33-100, Poland

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Warsaw, ?01-192, Poland

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GSK Investigational Site

Wroclaw, 50-088, Poland

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GSK Investigational Site

Zawadzkie, 47-120, Poland

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GSK Investigational Site

Brasov, 500091, Romania

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GSK Investigational Site

Brasov, 500283, Romania

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GSK Investigational Site

Bucharest, 020395, Romania

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GSK Investigational Site

Bucharest, 030961, Romania

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GSK Investigational Site

Bucharest, 051543, Romania

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GSK Investigational Site

Târgu Mureş, 540136, Romania

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GSK Investigational Site

Krasnodar, 350012, Russia

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GSK Investigational Site

Moscow, 1154461, Russia

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GSK Investigational Site

Moscow, 119333, Russia

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GSK Investigational Site

Moscow, 119435, Russia

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GSK Investigational Site

Moscow, 119991, Russia

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Moscow, 127473, Russia

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GSK Investigational Site

Moscow, 129110, Russia

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GSK Investigational Site

Omsk, 644050, Russia

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GSK Investigational Site

Penza, 440067, Russia

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GSK Investigational Site

Perm, 614066, Russia

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GSK Investigational Site

Saint Petersburg, 191036, Russia

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GSK Investigational Site

Saint Petersburg, 192148, Russia

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GSK Investigational Site

Saint Petersburg, 192212, Russia

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GSK Investigational Site

Saint Petersburg, 193312, Russia

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GSK Investigational Site

Saint Petersburg, 194100, Russia

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Saint Petersburg, 194223, Russia

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GSK Investigational Site

Saint Petersburg, 194291, Russia

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GSK Investigational Site

Saint Petersburg, 196191, Russia

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Saint Petersburg, 196240, Russia

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GSK Investigational Site

Saint Petersburg, 196657, Russia

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Samara, 443031, Russia

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Saransk, 430000, Russia

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GSK Investigational Site

Saratov, 410012, Russia

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GSK Investigational Site

St'Petersburg, 191144, Russia

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GSK Investigational Site

Tomsk, 634 050, Russia

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GSK Investigational Site

Ufa, 450008, Russia

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GSK Investigational Site

Volgograd, 400131, Russia

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GSK Investigational Site

Voronezh, 394036, Russia

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GSK Investigational Site

Yaroslavl, 150003, Russia

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Boksburg, Gauteng, 1459, South Africa

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Johannesburg, Gauteng, 1818, South Africa

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Pretoria, Gauteng, 0083, South Africa

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Pretoria, Gauteng, 0184, South Africa

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GSK Investigational Site

Middelburg, Mpumalanga, 1055, South Africa

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GSK Investigational Site

Panorama, Western Province, 7500, South Africa

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GSK Investigational Site

Bellville, 7530, South Africa

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Bloemfontein, 9301, South Africa

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Cape Town, 7700, South Africa

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Durban, 4001, South Africa

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eMkhomazi, 4170, South Africa

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Pretoria, 0181, South Africa

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Somerset West, 7130, South Africa

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GSK Investigational Site

Soweto, 1818, South Africa

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GSK Investigational Site

Vosloorus Ext 2, 1475, South Africa

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GSK Investigational Site

Badalona, 08916, Spain

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GSK Investigational Site

Barcelona, 08003, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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Related Publications (1)

• Bareille P, Forth R, Imber V, Bondarenko I, Michaud A, Majorek-Olechowska B. Once-daily fluticasone furoate/vilanterol vs once-daily fluticasone furoate in patients with asthma aged 5 to 17 years. Ann Allergy Asthma Immunol. 2024 Nov;133(5):537-544.e4. doi: 10.1016/j.anai.2024.06.024. Epub 2024 Jun 25.

  PMID: 38936466 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

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
• Masking Details: This will be a double blind study. Subjects and investigator will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive FDC of FF/VI inhalation powder compared to FF inhalation powder, once daily in cohort A and cohort B.

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 14, 2017
• Study Start: October 20, 2017
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: June 22, 2025
• Results First Posted: October 12, 2022

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Locations

ME (6); JP (16); ES (4); US (49); CN (2); AR (16); RU (29); HU (3); CA (3); PL (17); BU (4); LI (1); DE (4); RO (6); ZA (15); IT (8)