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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: Cetirizine 10mg; Drug: placebo; Drug: GSK835726 10mg; Drug: GSK1004723 1000mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972504

112864

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 bilirubin <or=1.5xULN

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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54 participants in 4 patient groups, including a placebo group

GSK835726 (10mg)

Active Comparator group

Description:

10mg oral dose

Treatment:

Drug: GSK835726 10mg

GSK1004723 (1000mcg)

Active Comparator group

Description:

1000mcg nasal spray solution

Treatment:

Drug: GSK1004723 1000mcg

Cetirizine 10mg

Active Comparator group

Description:

10mg cetirizine as active comparator

Treatment:

Drug: Cetirizine 10mg

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo