Last updated: 11/07/2018 09:32:02

A four-way crossover, single and repeat dose study to determine the dose proportionality and absolute bioavailability of fluticasone furoate inhalation powder administered by novel dry powder inhaler (NDPI)

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GSK study ID
115441
See study documents
Clinicaltrials.gov ID
NCT01669070
EudraCT ID
2012-000614-11
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: An open label, part-randomised, four-way crossover, single and repeat dose study to determine the dose proportionality and absolute bioavailability of fluticasone furoate (FF) when administered as FF inhalation powder from the novel dry powder inhaler in healthy subjects
Trial description: The purpose of this study is to demonstrate dose proportionality of the FF (50 microgram (mcg), 100 mcg or 200 mcg), when administered as a single and repeat dose from the NDPI containing FF formulated with lactose. In addition, the aim of this study is to determine the absolute bioavailability of the FF single strip product using the high strength product administered as a single dose with multiple inhalations and using 250 mcg intravenous (IV) FF.
This is a, part-randomized, open-label, 4 way crossover study (4 periods) in healthy adult subjects. During each period, subjects will receive FF in the morning and serial pharmacokinetic (PK) sampling (for up to 10 days for the inhaled treatment and up to 3 days for the IV treatment) and safety assessments will be performed. Each period will be separated by a washout period of at least 7 days and a follow-up telephone call will occur 7 -14 days after the last dose of study drug. The total duration of the study will be approximately 13-14 weeks for each subject.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

FF pharmacokinetics; parameters: (AUC(0-infinity)) , (AUC(0-24)) and (Cmax)

Timeframe: 54 days

Secondary outcomes:

Plasma FF PK parameters: t1/2, tmax, MRT for all treatments

Timeframe: 54 days

Plasma FF PK parameters: V and CL for IV treatment

Timeframe: 3 days (Study Day 52 to Study Day 54)

Mean absorption time (MAT) for inhaled treatments

Timeframe: 44 days

Safety of FF

Timeframe: 68 days

Interventions:
  • Drug: FF, 50 mcg
  • Drug: FF, 100 mcg
  • Drug: FF, 200 mcg
  • Drug: FF, 250 mcg
    • Enrollment:
    36
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Allen A, Bal J, Moore A, Stone S, Tombs L. Bioequivalence and dose proportionality of inhaled fluticasone furoate. J Bioequiv Availab. 2014;6(1):24-32.
    Medical condition
    Asthma
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    August 2012 to November 2012
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Healthy male or female subjects between 18 and 65 years of age and body mass index (BMI) within the range 18.5 to 29.0 kilogram/meter squared.
    • Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and bilirubin < or =1.5x upper limit of normal (ULN).
    • Subjects must not have a systolic blood pressure above 145 milimeter(mm) of mercury(Hg) or a diastolic pressure above 85
    • mmHg at the screening visit.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male or female subjects between 18 and 65 years of age and body mass index (BMI) within the range 18.5 to 29.0 kilogram/meter squared.
    • Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and bilirubin < or =1.5x upper limit of normal (ULN).
    • Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study.
    • Average QT duration corrected for heart rate by Fridericia’s formula (QTcF) <450 millisecond.
    • Forced Expiratory Volume in 1 Second (FEV1) > or = 85% predicted at screening.
    • Current non-smokers
    • Able to satisfactorily use the NDPI.
    Exclusion criteria:
    • Subjects must not have a systolic blood pressure above 145 milimeter(mm) of mercury(Hg) or a diastolic pressure above 85 mmHg at the screening visit.
    • History of breathing problems in adult life confirmed by normal lung function parameters (≥85% predicted).
    • Donation of more than 500 mL blood within a 56 day period.
    • Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
    • The subject treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
    • The subject has a positive: drug/alcohol, Hepatitis, HIV screen.
    • Abuse of alcohol.
    • Subject having positive cotinine and urine alcohol test.
    • Participated in >3 clinical trials in the previous 10 months (if male), or >2 clinical trials in the previous 10 months (if female), or the subject has participated in a study (including follow up) within 60 days prior to the first dosing day in the current study.
    • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
    • Taken systemic, oral or depot corticosteroids less than 12 weeks or inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
    • Use of prescription or non-prescription drugs.
    • History of severe milk protein allergy, sensitivity to any of the study medications, including immediate or delayed hypersensitivity to any intranasal, inhaled or systemic corticosteroid therapy.
    • Pregnant or lactating females.
    • Unwillingness or inability to follow the procedures outlined in the protocol.
    • Subject is mentally or legally incapacitated.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Groningen, Netherlands, 9713 GZ
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-16-11

    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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    Additional information
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