723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover

• Status: Completed
• Trial end date: 2009-08-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Cetirizine

Criteria

Inclusion Criteria:

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

• Males or female using contraceptives

• 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

• AST and ALT<2xULN; alkaline phosphatase and bilirubinExclusion 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

• Pregnant or llactating females

• 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