Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00404586 | Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber | PHASE1 | COMPLETED | 45 | — | — | Sep 11, 2006 | Jan 16, 2007 | Sep 12, 2017 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Treatment period 1 | EXPERIMENTAL | 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 2 | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| GW784568X | DRUG | 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 | DRUG | Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg. |
| Placebo | DRUG | Matching Placebo to GW784568X as aqueous nasal spray. |
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 bl...