Last updated: 11/04/2018 05:43:09

Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber

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GSK study ID
BGS105049
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Clinicaltrials.gov ID
NCT00404586
EudraCT ID
2006-002925-21
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, placebo-controlled, 4-period, incomplete block, crossover study of 7 days dosing of intranasal GW784568X (100mcg, 200mcg and 400mcg od), fluticasone propionate (200mcg od) and placebo (blinded for GW784568X vs placebo) to evaluate the efficacy and safety using an environmental chamber in male subjects with allergic rhinitis
Trial description: This study was designed to look at safety aspects and effects of intranasal doses of GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer with allergic rhinitis
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Nasal symptom scores after 7 days of dosing

Timeframe: after 7 days of dosing

Secondary outcomes:

Nasal symptom scores Eye symptom scores Other symptom scores Nasal secretion and airflow on Day 7 and Day 8 after being exposed to allergen

Timeframe: on Day 7 and Day 8

Interventions:
  • Drug: GW784568X
  • Drug: Fluticasone propionate
  • Drug: Placebo
    • Enrollment:
    45
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Rhinitis, Allergic, Perennial
    Product
    GW784568, fluticasone propionate
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to January 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Healthy with exception of seasonal rhinitis. May also have mild asthma.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy with exception of seasonal rhinitis. May also have mild asthma.
    • Weight greater than or equal to 50kg
    • Non-smoker for at least 12 months Exclusion criteria:
    • History of frequent nosebleeds
    • Have participated in another trial in the last 30 days.
    • Have donated blood in the previous 3 months
    • Have used prescription or non prescription drugs within last 7 days
    • Have history of alcohol/drug abuse within last 12 months
    • Have positive Hepatitis B or C test within 3 months of screening
    • Subject tested positive for HIV

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hannover, Niedersachsen, Germany, 30625
    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
    2007-16-01

    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

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    Additional information
    Results for study BGS105049 can be found on the GSK Clinical Study Register.
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