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.

NCT01686633 | Completed Phase 3 Results

• 1 other identifier: 116863
• Study Type: interventional
• Target: 1,040
• Locations: 11 countries
• Sites: 136

Brief Summary

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).

Conditions

Asthma

Keywords

asthma; pharmacogenetics; adult; vilanterol; adolescents; fluticasone furoate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period

  Baseline and Week 12

• Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period

  Baseline and Weeks 1-12

• Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period

  Baseline and Weeks 1-12

• Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period

  Baseline and Weeks 1-12

• Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period

  Baseline and Weeks 1-12

Study Arms (3)

Arm1: Fluticasone Furoate/ Vilanterol 200/25 mcg

EXPERIMENTAL

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

Arm 2: Fluticasone Furoate/ Vilanterol 100/25 mcg

EXPERIMENTAL

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

Arm 3: Fluticasone Furoate 100 mcg

EXPERIMENTAL

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

Interventions

Fluticasone Furoate/ Vilanterol 200/25 mcg DRUG

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

Arm1: Fluticasone Furoate/ Vilanterol 200/25 mcg

Fluticasone Furoate/ Vilanterol 100/25 mcg DRUG

Fluticasone furoate/ vilanterol will be available as 100/25 mcg NDPI with 30 doses per device and 100/25 mcg per actuation

Arm 2: Fluticasone Furoate/ Vilanterol 100/25 mcg

Fluticasone Furoate 100 mcg DRUG

Fluticasone furoate will be available as 100 mcg NDPI with 30 doses per device and 100/25 mcg per actuation

Arm 3: Fluticasone Furoate 100 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. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (136)

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

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Huntington Beach, California, 92647, United States

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Los Angeles, California, 90025, United States

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Newport Beach, California, 92663, United States

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Rancho Mirage, California, 92270, United States

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Rolling Hills Estates, California, 90274, United States

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San Diego, California, 92103-8415, United States

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Vista, California, 92083, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80206, United States

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Wheat Ridge, Colorado, 80033, United States

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Tallahassee, Florida, 32308, United States

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Coeur d'Alene, Idaho, 83814, United States

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Normal, Illinois, 61761, United States

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Bethesda, Maryland, 20814, United States

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Columbia, Maryland, 21044, United States

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North Dartmouth, Massachusetts, 02747, United States

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Minneapolis, Minnesota, 55402, United States

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Rolla, Missouri, 65401, United States

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St Louis, Missouri, 63143, United States

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Skillman, New Jersey, 08558, United States

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Charlotte, North Carolina, 28207, United States

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Raleigh, North Carolina, 27607, United States

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Shelby, North Carolina, 28152, United States

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Cincinnati, Ohio, 45231, United States

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Cincinnati, Ohio, 45242, United States

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Middleburg Heights, Ohio, 44130, United States

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Medford, Oregon, 97504, United States

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Easley, South Carolina, 29640, United States

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Fort Mill, South Carolina, 29707, United States

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Greenville, South Carolina, 29615, United States

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Orangeburg, South Carolina, 29118, United States

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Spartanburg, South Carolina, 29303, United States

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El Paso, Texas, 79903, United States

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Waco, Texas, 76712, United States

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Richmond, Virginia, 23219, United States

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Seattle, Washington, 98122, United States

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH, Argentina

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Nueve de Julio, Buenos Aires, B6500BWQ, Argentina

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San Rafael, Mendoza Province, 5600, Argentina

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Rosario, Santa Fe Province, S2000JKR, Argentina

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Berazategui, 1886, Argentina

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Buenos Aires, C1424BSF, Argentina

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Buenos Aires, C1425BEN, Argentina

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Buenos Aires, C1425FVH, Argentina

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Buenos Aires, C1426ABP, Argentina

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Mendoza, 5500, Argentina

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Mendoza, M5500CCG, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Rancagua, Reg Del Libert Bern Ohiggins, 2841959, Chile

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Quillota, Región de Valparaíso, 2260000, Chile

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Valparaíso, Región de Valparaíso, 2341131, Chile

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Viña del Mar, Región de Valparaíso, Chile

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Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile

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Santiago, Región Metro de Santiago, 7500800, Chile

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Santiago, 8380453, Chile

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Potsdam, Brandenburg, 14467, Germany

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Frankfurt am Main, Hesse, 60389, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Koblenz, Rhineland-Palatinate, 56068, Germany

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Leipzg, Saxony, 04109, Germany

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Magdeburg, Saxony-Anhalt, 39112, Germany

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Großhansdorf, Schleswig-Holstein, 22927, Germany

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Berlin, 10717, Germany

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Berlin, 10787, Germany

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Berlin, 12203, Germany

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Berlin, 13086, Germany

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Berlin, 14050, Germany

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Zapopan, Jalisco, 45040, Mexico

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Morelia, Michoacán, 58070, Mexico

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Monterrey, Nuevo León, 64000, Mexico

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Villahermosa, Tabasco, 86100, Mexico

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Almelo, 7609 PP, Netherlands

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Breda, 4819 EV, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Enschede, 7513 ER, Netherlands

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Hoorn, 1624 NP, Netherlands

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Veldhoven, 5504 DB, Netherlands

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Zutphen, 7207 AE, Netherlands

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Bialystok, 15-027, Poland

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Krakow, 30-901, Poland

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Krakow, 31-024, Poland

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Krakow, 31-455, Poland

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Lodz, 90-242, Poland

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Tarnów, 33-100, Poland

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Warsaw, 02-507, Poland

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Wroclaw, 53-301, Poland

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Bacau, 600114, Romania

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Brasov, 500112, Romania

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Bucharest, 020125, Romania

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Bucharest, 022102, Romania

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Bucharest, 030317, Romania

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Cluj-Napoca, 400370, Romania

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Craiova, 200642, Romania

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Deva, 330084, Romania

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Iași, 700115, Romania

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Piteşti, 110084, Romania

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Ploieşti, 100172, Romania

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Ploieşti, 100184, Romania

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Timișoara, 300310, Romania

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Blagoveshchensk, 675000, Russia

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Chelyabinsk, 454021, Russia

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Chita, 672090, Russia

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Ivanovo, 153005, Russia

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Kazan', 420015, Russia

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Moscow, 115446, Russia

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Moscow, 123182, Russia

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Moscow, 123367, Russia

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Nizhny Novgorod, 603126, Russia

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Pyatigorsk, 357538, Russia

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Ryazan, 390039, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 194356, Russia

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Saint Petersburg, 197022, Russia

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Stavropol, 355030, Russia

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Tomsk, 634 050, Russia

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Vladivostok, 690950, Russia

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Voronezh, 394066, Russia

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Yekaterinburg, 620109, Russia

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Gothenburg, SE-413 90, Sweden

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Linköping, SE-582 16, Sweden

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Luleå, SE-971 89, Sweden

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Lund, SE-221 85, Sweden

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Uppsala, SE-751 85, Sweden

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Dnipropetrovsk, 49051, Ukraine

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Kharkiv, 61002, Ukraine

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Kharkiv, 61124, Ukraine

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Kiev, 03680, Ukraine

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Kyiv, 03680, Ukraine

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Kyiv, 04201, Ukraine

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Poltava, 36024, Ukraine

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Vinnytsia, 21018, Ukraine

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Vinnytsia, 21029, Ukraine

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GSK Investigational Site

Zaporizhia, 69035, Ukraine

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Zaporizhia, 69063, Ukraine

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Zaporizhia, 69076, Ukraine

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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 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.

  PMID: 26291137 DERIVED

Related 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.

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate; vilanterol

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

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: September 20, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 15, 2013
• Last Updated: January 24, 2018
• Results First Posted: June 6, 2014

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

RU (19); AR (12); SE (5); UA (12); NL (7); CL (7); PL (8); DE (12); US (37); ME (4); RO (13)