Last updated: 11/04/2018 12:07:45

Examine the effect of repeat inhaled doses of GW870086X on lung function in mild asthmatic male subjects

GSK study ID
SIG102335
See study documents
Clinicaltrials.gov ID
NCT00483899
EudraCT ID
2004-002771-17
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: Double-blind, placebo-controlled, 3-way crossover study to investigate the effect of 7-days repeat once daily inhaled doses of GW870086X administered via DISKHALER on airway responsiveness to AMP in mild steroid-naive male asthmatics
Trial description: This study was designed to look at safety aspects and effects of repeat inhaled doses of GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (COPD)
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change in lung function 2 hours after treatment on day 7

Timeframe: on day 7

Secondary outcomes:

Change in lung function 14 and 26 hours after treatment on day 7; Change in lung function 2 hours after treatment on day 1; Effects on blood and urine tests; effects on the heart, pulse rate and blood pressure; effects on the lungs

Timeframe: 2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;

Interventions:
  • Drug: GW870086X
  • Drug: Placebo
    • Enrollment:
    20
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    GW870086
    Collaborators
    Not applicable
    Study date(s)
    October 2005 to December 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Male subjects aged 18-55
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Male subjects aged 18-55
    • Documented history of bronchial asthma diagnosed at least 6 months ago.
    • Only being treated with short-acting beta-2-agonist therapy e.g. Ventolin
    • Documented sensitivity to adenosine mono phosphate (AMP) at screening visit
    • Demonstrate repeatable and reproducable response to inhaled AMP at the run-in visit Exclusion criteria:
    • Any significant illness or disease
    • History of life threatening asthma
    • History of respiratory tract infection
    • Subjects who take medication for their asthma, or other conditions, not compatible with this study.
    • Smoker
    • Subjects who are oversensitive to corticosteroids
    • History of drug or alcohol abuse
    • Donated blood within last 3 months
    • Been involved in another clinical trial during the last 3 months
    • Subjects who work night shifts
    • Subjects who are undergoing de-sensitisation therapy

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SE5 8AF
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Manchester, Lancashire, United Kingdom, M23 9LT
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    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
    2006-15-12

    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

    Participate in clinical trial
    Additional information
    Results for study SIG102335 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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