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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2013-16-07
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
Location
GSK Investigational Site
Beijing, China, 100050
Status
Study Complete
Location
GSK Investigational Site
Seoul, South Korea, 130-709
Status
Study Complete
Location
GSK Investigational Site
Yinchuan, Ningxia, China, 750004
Status
Study Complete
Location
GSK Investigational Site
Chongqing, China
Status
Study Complete
Location
GSK Investigational Site
Quezon City, Philippines, 1101
Status
Study Complete
Location
GSK Investigational Site
Marilao, Bulacan, Philippines, 3019
Status
Study Complete
Location
GSK Investigational Site
Seoul,, South Korea, 120-752
Status
Study Complete
Location
GSK Investigational Site
Haikou, Hainan, China, 570311
Status
Study Complete
Location
GSK Investigational Site
ILSANSEO-GU, GOYANG-SI, GYEONGGI-DO, South Korea, 411706
Status
Study Complete
Location
GSK Investigational Site
Beijing, China, 100029
Status
Study Complete
Location
GSK Investigational Site
Pusan, South Korea, 602-739
Status
Study Complete
Location
GSK Investigational Site
Xian, Shaanxi, China, 710032
Status
Study Complete
Location
GSK Investigational Site
Chongqing, China, 400037
Status
Study Complete
Location
GSK Investigational Site
Seongnam-si, Gyeonggi-do, South Korea, 463-707
Status
Study Complete
Location
GSK Investigational Site
Beijing, China, 100034
Status
Study Complete
Location
GSK Investigational Site
Cheongju, Chungcheongbuk-do, South Korea, 361-711
Status
Study Complete
Location
GSK Investigational Site
Hang Zhou, Zhejiang, China, 310003
Status
Study Complete
Location
GSK Investigational Site
Bucheon-si, Gyeonggi-Do, South Korea, 420-767
Status
Study Complete
Location
GSK Investigational Site
Hangzhou, China, 310016
Status
Study Complete

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
Completed
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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