Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Rhinitis, Allergic, Perennial

Eligibility:

MALE

18-65 years

Phase:

PHASE1

Brief Summary

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 rhiniti...

Detailed Description

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 (b...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 11 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 16 2007

    Estimated Enrollment :

    45 Patients enrolled

    Trial Details

    Trial ID

    NCT00404586

    Start Date

    September 11 2006

    End Date

    January 16 2007

    Last Update

    September 12 2017

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    GSK Investigational Site

    Hanover, Lower Saxony, Germany, 30625