Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
Phase 1
Completed
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Registration Number
- NCT00404586
- Lead Sponsor
- GlaxoSmithKline
- 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 rhinitis
- 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 (blinded for GW784568X vs placebo) to evaluate the efficacy and safety using an environmental chamber in male subjects with allergic rhinitis
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 45
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment period 2 GW784568X 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. Treatment period 3 GW784568X 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. Treatment period 4 Fluticasone propionate 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. Treatment period 1 GW784568X 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. Treatment period 4 Placebo 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. Treatment period 3 Fluticasone propionate 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. Treatment period 2 Fluticasone propionate 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. Treatment period 1 Fluticasone propionate 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.
- Primary Outcome Measures
Name Time Method Nasal symptom scores after 7 days of dosing after 7 days of dosing
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Hannover, Niedersachsen, Germany