Last updated: 11/07/2018 07:18:07

A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects with COPD

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GSK study ID
114156
See study documents
Clinicaltrials.gov ID
NCT01192191
See results summary
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 Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Japanese Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of participants with any non-serious adverse event (AE) and any serious adverse event (SAE) throughout the treatment period

Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

Number of participants with any drug-related AE and any drug-related SAE throughout the treatment period

Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

Secondary outcomes:

Number of participants with pneumonia during the treatment period

Timeframe: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

Number of participants for the indicated hematological parameters who experienced low, normal, and high levels at Baseline (BL) and Week 52/Withdrawal (WD)

Timeframe: Baseline (Week -2), and Week 52/Withdrawal (WD)

Number of participants for the indicated clinical chemistry and urinalysis parameters who experienced a low, normal, and high levels at Baseline (BL) and Week 52/Withdrawal (WD)

Timeframe: Baseline (Week -2), and Week 52/Withdrawal (WD

Number of participants for the indicated urinalysis parameters tested by dipstick at Baseline (BL) and Week 52/Withdrawal (WD)

Timeframe: Baseline (Week -2), Week 52/Withdrawal (WD)

Change from Baseline in 24-hour urinary cortisol excretion at Weeks 24 and 52/Withdrawal (WD)

Timeframe: Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)

Change from Baseline in blood pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD

Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD

Change from Baseline in heart rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD

Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD

Number of participants with abnormal 12-lead electrocardiogram (ECG) findings

Timeframe: Baseline (Week -2), Week 12, Week 24, and Week 52

Interventions:
  • Drug: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg
  • Drug: Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
    • Enrollment:
    187
    Primary completion date:
    2012-04-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone furoate, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    August 2010 to January 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Out patient at least 40 years of age
    • Both genders; females childbearing potencial must be willing to use birth control method
    • Current diagnosis of sthma
    • Respiratory disorders other than COPD
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Out patient at least 40 years of age
    • Both genders; females childbearing potencial must be willing to use birth control method
    • A diagnosis of COPD at Screening
    • Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
    • Post-bronchodilator FEV1/FVC ratio of less than 70%
    • Post-bronchodilator FEV1 of less than 80%
    Exclusion criteria:
    • Current diagnosis of sthma
    • Respiratory disorders other than COPD
    • Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
    • Concurrent other disease that would confound study participation or affect subject safety
    • Allergies to study drugs, study drugs' excipients, medications related to study drugs
    • Taking another investigational medication or medication prohibited for use during this study

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Miyagi, Japan, 981-8563
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fukuoka, Japan, 819-8555
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fukushima, Japan, 964-0871
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Gunma, Japan, 371-0048
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nagano, Japan, 390-0303
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hyogo, Japan, 651-0073
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 34 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    2012-04-01
    Actual study completion date
    2012-04-01

    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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