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.

NCT ID: NCT01686633

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1040 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-20
• Study Completion Date: 2013-10-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluticasone Furoate/ Vilanterol 200/25 mcg

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Fluticasone Furoate/ Vilanterol 100/25 mcg

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Fluticasone Furoate 100 mcg

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Newport Beach, California, United States

GSK Investigational Site

Rancho Mirage, California, United States

GSK Investigational Site

Rolling Hills Estates, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Vista, California, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Wheat Ridge, Colorado, United States

GSK Investigational Site

Tallahassee, Florida, United States

GSK Investigational Site

Coeur d'Alene, Idaho, United States

GSK Investigational Site

Normal, Illinois, United States

GSK Investigational Site

Bethesda, Maryland, United States

GSK Investigational Site

Columbia, Maryland, United States

GSK Investigational Site

North Dartmouth, Massachusetts, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Rolla, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Skillman, New Jersey, United States

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Charlotte, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Shelby, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

GSK Investigational Site

Middleburg Heights, Ohio, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Easley, South Carolina, United States

GSK Investigational Site

Fort Mill, South Carolina, United States

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Greenville, South Carolina, United States

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Orangeburg, South Carolina, United States

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Spartanburg, South Carolina, United States

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El Paso, Texas, United States

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Waco, Texas, United States

GSK Investigational Site

Richmond, Virginia, United States

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Seattle, Washington, United States

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Nueve de Julio, Buenos Aires, Argentina

GSK Investigational Site

San Rafael, Mendoza Province, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Berazategui, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

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Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Mendoza, , Argentina

GSK Investigational Site

Mendoza, , Argentina

GSK Investigational Site

San Miguel de Tucumán, , Argentina

GSK Investigational Site

Rancagua, Reg Del Libert Bern Ohiggins, Chile

GSK Investigational Site

Quillota, Región de Valparaíso, Chile

GSK Investigational Site

Valparaíso, Región de Valparaíso, Chile

GSK Investigational Site

Viña del Mar, Región de Valparaíso, Chile

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, , Chile

GSK Investigational Site

Potsdam, Brandenburg, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Koblenz, Rhineland-Palatinate, Germany

GSK Investigational Site

Leipzg, Saxony, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

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Großhansdorf, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

GSK Investigational Site

Zapopan, Jalisco, Mexico

GSK Investigational Site

Morelia, Michoacán, Mexico

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Monterrey, Nuevo León, Mexico

GSK Investigational Site

Villahermosa, Tabasco, Mexico

GSK Investigational Site

Almelo, , Netherlands

GSK Investigational Site

Breda, , Netherlands

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Eindhoven, , Netherlands

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Enschede, , Netherlands

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Hoorn, , Netherlands

GSK Investigational Site

Veldhoven, , Netherlands

GSK Investigational Site

Zutphen, , Netherlands

GSK Investigational Site

Bialystok, , Poland

GSK Investigational Site

Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Tarnów, , Poland

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Warsaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Bacau, , Romania

GSK Investigational Site

Brasov, , Romania

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Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Cluj-Napoca, , Romania

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Craiova, , Romania

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Deva, , Romania

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Iași, , Romania

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Piteşti, , Romania

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Ploieşti, , Romania

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Ploieşti, , Romania

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Timișoara, , Romania

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Blagoveshchensk, , Russia

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Chelyabinsk, , Russia

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Chita, , Russia

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Ivanovo, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Pyatigorsk, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

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Saint Petersburg, , Russia

GSK Investigational Site

Stavropol, , Russia

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Tomsk, , Russia

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Vladivostok, , Russia

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Voronezh, , Russia

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Yekaterinburg, , Russia

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Gothenburg, , Sweden

GSK Investigational Site

Linköping, , Sweden

GSK Investigational Site

Luleå, , Sweden

GSK Investigational Site

Lund, , Sweden

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Uppsala, , Sweden

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Dnipropetrovsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Poltava, , Ukraine

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Vinnytsia, , Ukraine

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Vinnytsia, , Ukraine

GSK Investigational Site

Zaporizhia, , Ukraine

GSK Investigational Site

Zaporizhia, , Ukraine

GSK Investigational Site

Zaporizhia, , Ukraine

Countries

United States; Argentina; Chile; Germany; Mexico; Netherlands; Poland; Romania; Russia; Sweden; Ukraine

References

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.

Reference Type: DERIVED

PMID: 36472162 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26291137 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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

Other Identifiers

116863

Identifier Type: -

Identifier Source: org_study_id