Last updated: 11/07/2018 11:10:45
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.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Baseline and Week 12
Secondary outcomes:
Change from Baseline in clinic visit trough FEV1 at the end of the 12-week treatment period
Timeframe: Baseline and Week 12
Change from Baseline in the percentage of rescue-free 24-hour (hr) periods during the 12-week treatment period
Timeframe: Baseline and Weeks 1-12
Change from Baseline in the percentage of symptom-free 24-hour (hr) periods during the 12-week treatment period
Timeframe: Baseline and Weeks 1-12
Change from Baseline in daily morning (AM) peak expiratory flow (PEF) averaged over the 12-week treatment period
Timeframe: Baseline and Weeks 1-12
Change from Baseline in daily evening (PM) PEF averaged over the 12-week treatment period
Timeframe: Baseline and Weeks 1-12
Interventions:
Drug: Fluticasone Furoate/ Vilanterol 200/25 mcg
Drug: Fluticasone Furoate/ Vilanterol 100/25 mcg
Drug: Fluticasone Furoate 100 mcg
Enrollment:
1040
Observational study model:
Not applicable
Primary completion date:
2013-15-10
Time perspective:
Not applicable
Clinical 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.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
September 2012 to October 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- 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
- 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.
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500800
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23219
Status
Study Complete
Location
GSK Investigational Site
Fort Mill, South Carolina, United States, 29707
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
Shelby, North Carolina, United States, 28152
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Columbia, Maryland, United States, 21044
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1424BSF
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103-8415
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98122
Status
Study Complete
Location
GSK Investigational Site
Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, 4000
Status
Study Complete
Location
GSK Investigational Site
Middleburg Heights, Ohio, United States, 44130
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Rancagua, Reg Del Libert Bern Ohiggins, Chile, 2841959
Status
Study Complete
Location
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63143
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92083
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Skillman, New Jersey, United States, 08558
Status
Study Complete
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000JKR
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
Status
Study Complete
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-15-10
Actual study completion date
2013-15-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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