Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
NCT ID: NCT00404586
Last Updated: 2017-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2006-09-11
2007-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
Study Groups
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Treatment period 1
In treatment period subjects will receive once daily 100 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
GW784568X
GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.
Fluticasone propionate
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
Treatment period 2
In treatment period subjects will receive once daily 200 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
GW784568X
GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.
Fluticasone propionate
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
Treatment period 3
In treatment period subjects will receive once daily 400 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
GW784568X
GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.
Fluticasone propionate
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
Treatment period 4
In treatment period subjects will receive once daily Placebo and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive Placebo and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
Fluticasone propionate
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
Placebo
Matching Placebo to GW784568X as aqueous nasal spray.
Interventions
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GW784568X
GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.
Fluticasone propionate
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
Placebo
Matching Placebo to GW784568X as aqueous nasal spray.
Eligibility Criteria
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Inclusion Criteria
* Weight greater than or equal to 50kg
* Non-smoker for at least 12 months
Exclusion Criteria
* 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
18 Years
65 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Hanover, Lower Saxony, Germany
Countries
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Other Identifiers
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BGS105049
Identifier Type: -
Identifier Source: org_study_id
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