Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.

• Male

• Aged 18 - 65

• Weight 50kg+, BMI 19-32 kg/m2

• Exhibit response to Challenge Chamber and skin prick test.

• Non-smoker

• Capable of giving informed consent

Exclusion Criteria:

• No nasal structural abnornmality/polyposis, surgery, infection.

• any respiratory disease, other than mild asthma or seasonal allergic rhinitis

• participated in another clinical study within 30 days.

• Subject has donated a unit of blood within 1 month

• Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.

• History of sensitivty to drug

• History of alcohol/drug abuse within 12 months.

• Positive Hepatitis B antibody test

• Positive HIV antibody test

• Risk of non-compliance with study protocol

• Perenial allergic rhinitis

• Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.

• Past or present disease that may affect outcome, as judge by investigator Specific Immunotherapy within 2 years