Last updated: 11/07/2018 06:42:54

Evaluating the efficacy and safety of fluticasone furoate/vilanterol trifenatate in the treatment of asthma in adolescent and adult subjects of Asian ancestry.

GSK study ID
113719
Clinicaltrials.gov ID
EudraCT ID
Not applicable
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, placebo-controlled, parallel group, multicentre study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with low to mid-strength inhaled corticosteroid or low-strength combination therapy.
Trial description: A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with lowe to mid-strength inhaled corticosteroid or low-strength combination therapy.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline (BL) in daily evening (PM) peak expiratory flow (PEF) averaged over the 12-week Treatment Period

Timeframe: Baseline and Weeks 1-12 (up to Day 84)

Secondary outcomes:

Mean change from Baseline in daily morning (AM) PEF averaged over the 12-week Treatment Period

Timeframe: Baseline and Weeks 1-12 (up to Day 84)

Mean 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 (up to Day 84)

Mean 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 (up to Day 84)

Change from Baseline in total Asthma Quality of Life Questionnaire (AQLQ) score at Week 12

Timeframe: Baseline and Week 12

Interventions:
  • Drug: GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)
  • Drug: Placebo
  • Enrollment:
    311
    Primary completion date:
    2013-16-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Jiangtao Lin, Huaping Tang, Ping Chen, Haoyan Wang, Mi-Kyeong Kim, Jodie Crawford, Loretta Jacques, Sally Stone. Efficacy and safety evaluation of once-daily fluticasone furoate/vilanterol in Asian patients with asthma uncontrolled on a low- to mid-strength inhaled corticosteroid or low-dose inhaled corticosteroid/long-acting beta2-agonist. Allergy Asthma Proc. 2016;37(4):302-310(9)
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    January 2012 to July 2013
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 100 years
    Accepts healthy volunteers
    No
    • 1. Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study.
    • 2. Type of Subject: Outpatients, of Asian ancestry, 12 years of age or older at Visit 1 (or ≥18 years of age or older if local regulations or the regulatory status of study medication permit enrolment of adults only), with a diagnosis of asthma as defined by the Global Initiative for Asthma [GINA, 2009] at least 12 weeks prior to Visit 1.
    • 1. History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years.
    • 2. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the 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, is expected to affect the subject’s asthma status or the subject’s ability to participate in the study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Shanghai, China, 200433
    Status
    Study Complete
    Location
    GSK Investigational Site
    Shenzhen, Guangdong, China, 518020
    Status
    Study Complete
    Location
    GSK Investigational Site
    Qingdao, Shandong, China, 266071
    Status
    Study Complete
    Location
    GSK Investigational Site
    Zhanjiang, Guangdong, China, 524001
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nanning, Guangxi, China, 530021
    Status
    Study Complete
    Location
    GSK Investigational Site
    Shenyang, Liaoning, China, 110015
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    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
    Study complete
    Actual primary completion date
    2013-16-07
    Actual study completion date
    2013-16-07

    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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