Last updated: 11/07/2018 00:20:37

The Effect Of AVANDIA On The Late Asthmatic Response

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GSK study ID
104385
See study documents
Clinicaltrials.gov ID
NCT00318630
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 randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo
Trial description: This study is to investigate the effects of AVANDIA on the asthmatic response.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

The effect of repeat oral doses of AVANDIA for 28 days on the late asthmatic response to inhaled allergen. Measured as lung function 4-10 hours after allergen challenge after 28 days dosing.

Timeframe: Up to 43 days

Secondary outcomes:

The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability.

Timeframe: Up to 43 days

Interventions:
  • Drug: Rosiglitazone
  • Drug: Placebo
    • Enrollment:
    26
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    This study has not been published in the scientific literature.
    Medical condition
    Asthma
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    July 2005 to June 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Mild asthmatic treated with short-acting beta agonists only, non-smoker.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Mild asthmatic treated with short-acting beta agonists only, non-smoker. Exclusion criteria: -Inability to abstain from medications other than short-acting beta agonists and paracetamol.
    • Recent administration of steroids.
    • Recent respiratory infection or exacerbation of asthma.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wellington, New Zealand, 6035
    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
    2006-30-06

    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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    Additional information
    Results for study 104385 can be found on the GSK Clinical Study Register.
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