Last updated: 11/07/2018 07:05:52

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

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GSK study ID
113989
See study documents
Clinicaltrials.gov ID
NCT01244984
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 and FF Inhalation Powder in Japanese Subjects with asthma
Trial description: The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with any non-serious adverse event (AE) and any serious adverse event (SAE)

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

Secondary outcomes:

Laboratory parameters of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

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

Laboratory parameters of eosinophils, platelet count, white blood cell (WBC), and total neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

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

Laboratory parameter of hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD

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

Laboratory parameter of hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

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

Laboratory parameter of red blood cell count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

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

Laboratory parameter of albumin and total protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

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

Laboratory parameter of alkaline phosphatase (AP), alanine amino transferase (ALT), aspartate amino transferase (AST), creatine kinase, gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD

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

Laboratory parameter of bilirubin (direct [BD], indirect [BI], total [BT], creatinine, and uric acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

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

Laboratory parameter of chloride, carbon dioxide content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

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

Laboratory parameter of urine potential of hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

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

Laboratory parameter of urine specific gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD

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

Number of participants for the indicated uninalysis parameters tested by dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD

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

Change from Baseline in the 24-hour urinary cortisol excretion

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

Change from Baseline in blood pressure

Timeframe: Baseline (Week 0), Week 12, Week 24, and Week 52/WD

Change from Baseline in heart rate (HR)

Timeframe: Baseline (Week 0), Week 12, Week 24, and Week 52/WD

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

Timeframe: Week 12, Week 24, and Week 52/WD

Number of participants with severe asthma exacerbation during the study treatment

Timeframe: Baseline up to Week 52

Change from Baseline in diary data - morning (AM) peak expiratory flow (PEF) and evening (PM) PEF during the study treatment

Timeframe: Baseline up to Week 52

Change from Baseline in asthma symptom score during the study treatment

Timeframe: Baseline up to Week 52

Change from Baseline in the percentage of symptom-free 24-hour periods during the study treatment

Timeframe: Baseline up to Week 52

Change from Baseline in the percentage of rescue-free 24-hour periods

Timeframe: Baseline up to Week 52

Number of Rescue Medication Inhalations

Timeframe: Baseline up to Week 52

Interventions:
  • Drug: Fluticasone Furoate/GW642444 Inhalation Powder
  • Drug: Fluticasone Furoate Inhalation Powder
    • Enrollment:
    243
    Primary completion date:
    2012-21-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Muraki M, Soutome T, Hashimoto K, Tohda Y. Long-term study of fluticasone furoate/vilanterol combination (FF/VI) and FF alone in Japanese adult patients with bronchial asthma. Allergol Immunol. 2013;20(10):110-25.
    Medical condition
    Asthma
    Product
    fluticasone furoate, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    July 2010 to January 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Out patient at least 18 years of age
    • Both genderds; females of childbearing potential must be willing to use birth control method
    • History of life-threating asthma
    • Respiratory infection or oral candidiasis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Out patient at least 18 years of age
    • Both genderds; females of childbearing potential must be willing to use birth control method
    • A diagnosis of asthma at least 6 months prior to Screening
    • A best FEV1 of at least 50% of the predicted nomal value at Screening
    • Subjects have been receiving maintanance therapy for asthma, for at least 4 weeks prior to Screening
    Exclusion criteria:
    • History of life-threating asthma
    • Respiratory infection or oral candidiasis
    • Asthma exacerbation within 12 weeks
    • Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
    • Allergies to study drugs, study drugs7 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
    Okayama, Japan, 701-0304
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ibaraki, Japan, 302-0022
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kyoto, Japan, 601-1495
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hiroshima, Japan, 730-0844
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Osaka, Japan, 569-1192
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Miyagi, Japan, 983-8520
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 30 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
    2012-21-01
    Actual study completion date
    2012-21-01

    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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