Last updated: 11/04/2018 05:39:39

Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma

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GSK study ID
B2E101312
Clinicaltrials.gov ID
NCT00354666
EudraCT ID
2004-001078-16
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 crossover study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled GSK159797 delivered by dry powder inhaler in mild to moderate asthmatic subjects
Trial description: This study was designed to test safety aspects and effects on lung function of a new dry powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with previous studies which have only used inhalation of the drug as a vapour.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GSK159797
    • Enrollment:
    20
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    milveterol
    Collaborators
    Not applicable
    Study date(s)
    September 2004 to December 2004
    Type
    Interventional
    Phase
    2

    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 females 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 females who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
    • Non-smokers.
    • Subjects that 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 had a cold or chest infection 2-4 weeks prior to the study.
    • Subjects who take medication for their asthma, or other conditions, not compatible with the study.

    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
    2004-02-12

    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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