Last updated: 11/04/2018 05:33:20

Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects

GSK study ID
B2A100517
Clinicaltrials.gov ID
NCT00354042
EudraCT ID
2004-001076-39
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 randomised, double-blind, placebo-controlled, dose ascending, 4 period crossover study to examine the safety, tolerability, pharmacodynamics and pharmacokinetics of repeat inhaled doses of GW597901X in asthmatic subjects
Trial description: This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW597901X
    • Enrollment:
    24
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    GW597901
    Collaborators
    Not applicable
    Study date(s)
    August 2004 to January 2005
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Years
    Accepts healthy volunteers
    no
    • Subjects with mild to moderate stable asthma but no other lung problems.
    • Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
    • Any significant illness.
    • Subjects with heart problems.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with mild to moderate stable asthma but no other lung problems.
    • Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
    • Non-Smokers.
    • Subjects who show a measurable improvement in the function of their lungs after a single dose of salbutamol.
    Exclusion criteria:
    • Any significant illness.
    • Subjects with heart problems.
    • Subjects who have a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma.
    • Subjects who take medication for their asthma, or other conditions, not compatible with this study.
    • Subjects who are over sensitive to salbutamol or to ipratropium.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-28-01

    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

    Additional information
    Not applicable
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