Last updated: 07/13/2020 16:30:04

Study With GW274150 In Patients With Mild Asthma

GSK study ID
INO102141
See study documents
Clinicaltrials.gov ID
NCT00273013
EudraCT ID
2004-000576-13
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: Single centre Allergen challenge study of GW274150 in mild asthmatic subjects
Trial description: This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Effect on the late asthmatic reaction following an inhaled allergen challenge

Timeframe: Up to Day 115

Secondary outcomes:

Measures of safety. Measures of lung function

Timeframe: Up to Day 115

Interventions:
  • Drug: GW274150
  • Drug: Singulair
  • Drug: Placebo
    • Enrollment:
    28
    Primary completion date:
    2005-28-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    GW274150
    Collaborators
    Not applicable
    Study date(s)
    November 2004 to October 2005
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Mild asthma: taking reliever medication (e.g. salbutamol) only.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Mild asthma: taking reliever medication (e.g. salbutamol) only.
    • Screening involves measuring responses to the lung challenge agents: allergen, AMP, and methacholine. Only those with specific types of response to these will be eligible for the study. Exclusion criteria:
    • Recent steroid treatment.
    • Significant illnesses or diseases other than asthma.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SE1 9RT
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Manchester, Lancashire, United Kingdom, M23 9LT
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    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
    2005-28-10
    Actual study completion date
    2005-28-10

    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 102141 can be found on the GSK Clinical Study Register.
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