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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Placebo; Drug: GW784568X; Drug: Fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00404586

BGS105049

Details and patient eligibility

About

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

Full 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

Enrollment: 45 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 4 patient groups, including a placebo group

Treatment period 1

Experimental group

Description:

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:

Drug: Fluticasone propionate

Drug: GW784568X

Treatment period 2

Experimental group

Description:

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:

Drug: Fluticasone propionate

Drug: GW784568X

Treatment period 3

Experimental group

Description:

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:

Drug: Fluticasone propionate

Drug: GW784568X

Treatment period 4

Placebo Comparator group

Description:

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:

Drug: Placebo

Drug: Fluticasone propionate