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).
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
GSK Investigational Site, Berazategui 1886, Argentina
GSK Investigational Site, Buenos Aires C1425BEN, Argentina
GSK Investigational Site, Buenos Aires C1425FVH, Argentina
GSK Investigational Site, Buenos Aires C1424BSF, Argentina
GSK Investigational Site, Ciudad Autónoma de Buenos Aires C1426ABP, Argentina
GSK Investigational Site, Mendoza 5500, Argentina
GSK Investigational Site, Mendoza M5500CCG, Argentina
GSK Investigational Site, San Miguel de Tucumán 4000, Argentina
GSK Investigational Site, Tucuman 4000, Argentina
GSK Investigational Site, Santiago 8380453, Chile
GSK Investigational Site, Berlin 14050, Germany
GSK Investigational Site, Berlin 10787, Germany
GSK Investigational Site, Berlin 12203, Germany
GSK Investigational Site, Berlin 13086, Germany
GSK Investigational Site, Berlin 10717, Germany
GSK Investigational Site, Almelo 7609 PP, Netherlands
GSK Investigational Site, Breda 4819 EV, Netherlands
GSK Investigational Site, Eindhoven 5623 EJ, Netherlands
GSK Investigational Site, Enschede 7513 ER, Netherlands
GSK Investigational Site, Hoorn 1624 NP, Netherlands
GSK Investigational Site, Veldhoven 5504 DB, Netherlands
GSK Investigational Site, Zutphen 7207 AE, Netherlands
GSK Investigational Site, Bialystok 15-027, Poland
GSK Investigational Site, Krakow 31-455, Poland
GSK Investigational Site, Krakow 31-024, Poland
GSK Investigational Site, Krakow 30-901, Poland
GSK Investigational Site, Lodz 90-242, Poland
GSK Investigational Site, Tarnow 33-100, Poland
GSK Investigational Site, Warszawa 02-507, Poland
GSK Investigational Site, Wroclaw 53-301, Poland
GSK Investigational Site, Bacau 600114, Romania
GSK Investigational Site, Brasov 500112, Romania
GSK Investigational Site, Bucharest 020125, Romania
GSK Investigational Site, Bucharest 030317, Romania
GSK Investigational Site, Bucuresti 022102, Romania
GSK Investigational Site, Cluj Napoca 400370, Romania
GSK Investigational Site, Craiova 200642, Romania
GSK Investigational Site, Deva 330084, Romania
GSK Investigational Site, Iasi 700115, Romania
GSK Investigational Site, Pitesti 110084, Romania
GSK Investigational Site, Ploiesti 100172, Romania
GSK Investigational Site, Ploiesti 100184, Romania
GSK Investigational Site, Timisoara 300310, Romania
GSK Investigational Site, Blagoveshchensk 675000, Russian Federation
GSK Investigational Site, Chelyabinsk 454021, Russian Federation
GSK Investigational Site, Chita 672090, Russian Federation
GSK Investigational Site, Ekaterinburg 620109, Russian Federation
GSK Investigational Site, Ivanovo 153005, Russian Federation
GSK Investigational Site, Kazan 420015, Russian Federation
GSK Investigational Site, Moscow 115446, Russian Federation
GSK Investigational Site, Moscow 123182, Russian Federation
GSK Investigational Site, Moscow 123367, Russian Federation
GSK Investigational Site, Nizhniy Novgorod 603126, Russian Federation
GSK Investigational Site, Pyatigorsk 357538, Russian Federation
GSK Investigational Site, Ryazan 390039, Russian Federation
GSK Investigational Site, St. Petersburg 194291, Russian Federation
GSK Investigational Site, St. Petersburg 194356, Russian Federation
GSK Investigational Site, St. Petersburg 197022, Russian Federation
GSK Investigational Site, Stavropol 355030, Russian Federation
GSK Investigational Site, Tomsk 634 050, Russian Federation
GSK Investigational Site, Vladivostok 690950, Russian Federation
GSK Investigational Site, Voronezh 394066, Russian Federation
GSK Investigational Site, Göteborg SE-413 90, Sweden
GSK Investigational Site, Linköping SE-582 16, Sweden
GSK Investigational Site, Luleå SE-971 89, Sweden
GSK Investigational Site, Lund SE-221 85, Sweden
GSK Investigational Site, Uppsala SE-751 85, Sweden
GSK Investigational Site, Dnipropetrovsk 49051, Ukraine
GSK Investigational Site, Kharkiv 61124, Ukraine
GSK Investigational Site, Kharkiv 61002, Ukraine
GSK Investigational Site, Kiev 03680, Ukraine
GSK Investigational Site, Kyiv 04201, Ukraine
GSK Investigational Site, Kyiv 03680, Ukraine
GSK Investigational Site, Poltava 36024, Ukraine
GSK Investigational Site, Vinnytsia 21018, Ukraine
GSK Investigational Site, Vinnytsia 21029, Ukraine
GSK Investigational Site, Zaporizhia 69035, Ukraine
GSK Investigational Site, Zaporizhia 69063, Ukraine
GSK Investigational Site, Zaporizhia 69076, Ukraine
GSK Investigational Site, Little Rock, Arkansas 72205, United States
GSK Investigational Site, Potsdam, Brandenburg 14467, Germany
GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires C1405BCH, Argentina
GSK Investigational Site, Nueve de Julio, Buenos Aires B6500BWQ, Argentina
GSK Investigational Site, Huntington Beach, California 92647, United States
GSK Investigational Site, Los Angeles, California 90025, United States
GSK Investigational Site, Newport Beach, California 92663, United States
GSK Investigational Site, Rancho Mirage, California 92270, United States
GSK Investigational Site, Rolling Hills Estates, California 90274, United States
GSK Investigational Site, San Diego, California 92103-8415, United States
GSK Investigational Site, Vista, California 92083, United States
GSK Investigational Site, Colorado Springs, Colorado 80907, United States
GSK Investigational Site, Denver, Colorado 80206, United States
GSK Investigational Site, Wheat Ridge, Colorado 80033, United States
GSK Investigational Site, Tallahassee, Florida 32308, United States
GSK Investigational Site, Frankfurt, Hessen 60389, Germany
GSK Investigational Site, Frankfurt, Hessen 60596, Germany
GSK Investigational Site, Coeur D'Alene, Idaho 83814, United States
GSK Investigational Site, Normal, Illinois 61761, United States
GSK Investigational Site, Zapopan, Jalisco 45040, Mexico
GSK Investigational Site, Bethesda, Maryland 20814, United States
GSK Investigational Site, Columbia, Maryland 21044, United States
GSK Investigational Site, North Dartmouth, Massachusetts 02747, United States
GSK Investigational Site, San Rafael, Mendoza 5600, Argentina
GSK Investigational Site, Morelia, Michoacán 58070, Mexico
GSK Investigational Site, Minneapolis, Minnesota 55402, United States
GSK Investigational Site, Rolla, Missouri 65401, United States
GSK Investigational Site, St. Louis, Missouri 63143, United States
GSK Investigational Site, Skillman, New Jersey 08558, United States
GSK Investigational Site, Charlotte, North Carolina 28207, United States
GSK Investigational Site, Raleigh, North Carolina 27607, United States
GSK Investigational Site, Shelby, North Carolina 28152, United States
GSK Investigational Site, Monterrey, Nuevo León 64000, Mexico
GSK Investigational Site, Cincinnati, Ohio 45231, United States
GSK Investigational Site, Cincinnati, Ohio 45242, United States
GSK Investigational Site, Middleburg Heights, Ohio 44130, United States
GSK Investigational Site, Medford, Oregon 97504, United States
GSK Investigational Site, Rancagua, Reg Del Libert Bern Ohiggins 2841959, Chile
GSK Investigational Site, Puente Alto - Santiago, Región Metro De Santiago 8207257, Chile
GSK Investigational Site, Santiago, Región Metro De Santiago 7500800, Chile
GSK Investigational Site, Koblenz, Rheinland-Pfalz 56068, Germany
GSK Investigational Site, Leipzg, Sachsen 04109, Germany
GSK Investigational Site, Magdeburg, Sachsen-Anhalt 39112, Germany
GSK Investigational Site, Rosario, Santa Fe S2000JKR, Argentina
GSK Investigational Site, Grosshansdorf, Schleswig-Holstein 22927, Germany
GSK Investigational Site, Easley, South Carolina 29640, United States
GSK Investigational Site, Fort Mill, South Carolina 29707, United States
GSK Investigational Site, Greenville, South Carolina 29615, United States
GSK Investigational Site, Orangeburg, South Carolina 29118, United States
GSK Investigational Site, Spartanburg, South Carolina 29303, United States
GSK Investigational Site, Villahermosa, Tabasco 86100, Mexico
GSK Investigational Site, El Paso, Texas 79903, United States
GSK Investigational Site, Waco, Texas 76712, United States
GSK Investigational Site, Quillota, Valparaíso 2260000, Chile
GSK Investigational Site, Valparaiso, Valparaíso 2341131, Chile
GSK Investigational Site, Viña del Mar, Valparaíso, Chile
GSK Investigational Site, Richmond, Virginia 23219, United States
GSK Investigational Site, Seattle, Washington 98122, United States