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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: GW784568X
* Drug: Fluticasone propionate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period 1<br>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. | Drug: GW784568X<br>* 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.<br>Drug: Fluticasone propionate<br>* Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.<br>|
| Experimental: Treatment period 2<br>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. | Drug: GW784568X<br>* 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.<br>Drug: Fluticasone propionate<br>* Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.<br>|
| Experimental: Treatment period 3<br>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. | Drug: GW784568X<br>* 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.<br>Drug: Fluticasone propionate<br>* Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.<br>|
| Placebo Comparator: Treatment period 4<br>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. | Drug: Fluticasone propionate<br>* Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.<br>Drug: Placebo<br>* Matching Placebo to GW784568X as aqueous nasal spray.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal symptom scores after 7 days of dosing |  | after 7 days of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal symptom scores Eye symptom scores Other symptom scores Nasal secretion and airflow on Day 7 and Day 8 after being exposed to allergen |  | on Day 7 and Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Environmental Challenge Chamber, GW784568X, Intranasal