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Evaluating the efficacy and safety of fluticasone furoate in the treatment of asthma in adults and adolescentsn/a

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GSK study ID
114496
See study documents
Clinicaltrials.gov ID
NCT01431950
See results summary
EudraCT ID
2011-001895-20
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.
Trial description: A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in clinic visit evening (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) at the end of the 24-week treatment period

Timeframe: Baseline and Week 24

Secondary outcomes:

Change from Baseline in the percentage of rescue-free 24-hour (hr) periods over the 24-week treatment period

Timeframe: From Baseline up to Week 24

Change from Baseline in daily evening (PM) peak expiratory flow (PEF) averaged over the 24-week treatment period

Timeframe: From Baseline up to Week 24

Change from Baseline in daily morning (AM) PEF averaged over the 24-week treatment period

Timeframe: From Baseline up to Week 24

Change from Baseline in the percentage of symptom-free 24-hour (hr) periods over the 24-week treatment period

Timeframe: From Baseline up to Week 24

Interventions:
  • Drug: fluticasone furoate
  • Drug: albuterol/salbutamol
    • Enrollment:
    238
    Primary completion date:
    2012-03-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Svedsater H, Jacques L, Goldfrad C, Bleecker ER.Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma.npj Primary Care Respiratory Medicine.2014;24:14019
    Medical condition
    Asthma
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    September 2011 to October 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 100 years
    Accepts healthy volunteers
    No
    • Signed informed consent
    • Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks prior to first visit
    • History of life threatening asthma
    • Respiratory infection or candidiasis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Signed informed consent
    • Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks prior to first visit
    • Both genders; females of child bearing potential must be willing to use appropriate contraception
    • Pre-bronchodilator FEV1 of 40-90% predicted
    • Reversibility FEV1 of at least 12% and 200mLs
    • Current asthma therapy that includes inhaled corticosteroid for at least 4 weeks prior to first visit
    Exclusion criteria:
    • History of life threatening asthma
    • Respiratory infection or candidiasis
    • Asthma exacerbation requiring OCS within last 4 weeks or overnight hospital stay within the last 3 months
    • Concurrent respiratory disease or other disease that would confound study participation of affect subject safety
    • Allergies to study drugs, study drug excipients, medications related to study drugs
    • Taking another investigational medication or medication prohibited for use during the study
    • Previous treatment with FF or FF/VI in a phase II or III study
    • Night shift workers
    • Children in care

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    San Miguel de Tucumán, Argentina, 4000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aigrefeuille Sur Maine, France, 44140
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Corsicana, Texas, United States, 75110
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toledo, Ohio, United States, 43617
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chalons en Champagne, France, 51000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, Argentina, C1425BEN
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Penza, Russia, 440067
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Villahermosa, Tabasco, Mexico, 86100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pyatigorsk, Russia, 357538
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newport Beach, California, United States, 92663
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Utica, New York, United States, 13502
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bethesda, Maryland, United States, 20814
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kazan, Russia, 420015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clearwater, Florida, United States, 33756
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nantes, France, 44300
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89119
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mexico City, Mexico, 07760
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brick, New Jersey, United States, 08724
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Canton, Ohio, United States, 44718
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orangeburg, South Carolina, United States, 29118
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sunset, Louisiana, United States, 70584
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Santiago, Región Metro De Santiago, Chile, 7500800
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Belgorod, Russia, 308007
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mendoza, Mendoza, Argentina, M5500CCG
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plymouth, Minnesota, United States, 55441
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Valparaiso, Valparaíso, Chile, 2341131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albany, Georgia, United States, 31707
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Long Beach, California, United States, 90808
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80907
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Metairie, Louisiana, United States, 70006
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45242
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vannes, France, 56000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Novokuznetsk, Russia, 654063
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bourg Des Comptes, France, 35890
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Laon, France, 02000
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40503
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2012-03-10
    Actual study completion date
    2012-03-10

    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.

    Additional information about the trial

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