Last updated: 11/04/2018 05:34:09

Investigation Of A New Medication (GW642444) In Asthmatic Patients

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GSK study ID
B2C101762
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Clinicaltrials.gov ID
NCT00354874
EudraCT ID
2004-002362-37
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 multi-centre, randomised, double-blind, placebo controlled, dose ascending, four way crossover study to examine efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat doses of GW642444
Trial description: This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.
Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

FEV1 at 24 hours after a single dose.

Timeframe: 24 hours on 4 separate occasions

Secondary outcomes:

FEV1 - Days 1 and 7

Timeframe: Days 1 and 7 on 4 separate occasions

Mean morning/evening PEFR

Timeframe: Days 3-8 on 4 separate occasions

BP, HR & QTc on Days 1 and 7

Timeframe: Days 1 and 7 on 4 separate occasions

Potassium and glucose on Days 1 and 7

Timeframe: Days 1 and 7 on 4 separate occasions

safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG

Timeframe: throughout study

PK parameters

Timeframe: Days 1, 4 and 7 on 4 separate occasions

Interventions:
  • Drug: GW642444
  • Drug: Placebo
  • Drug: salmeterol 50mcg
    • Enrollment:
    28
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    salmeterol, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    January 2005 to June 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
    • Non-smokers for at least 6 months.
    • Stable asthma. Exclusion criteria:
    • Abnormal findings on heart monitoring assessment.
    • Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
    • Currently taking doses of fluticasone propionate over 500mcg/day.
    • Unstable asthma medication.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wiesbaden, Hessen, Germany, 65187
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    GÖTEBORG, Sweden, SE-413 45
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Grosshansdorf, Schleswig-Holstein, Germany, 22927
    Status
    Study Complete
    Contact us

    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-07-06

    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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