Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: GSK835726 (50mg); Drug: GSK835726 (10mg); Other: Placebo; Drug: GSK835726 (100mg); Drug: Cetirizine (10mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851344

110163

Details and patient eligibility

About

A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis

Enrollment: 54 patients

Sex: Male

Ages: 18 to 60 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.
• Male
• Aged 18 - 60
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

54 participants in 5 patient groups, including a placebo group

GSK835726 (10mg)

Active Comparator group

Description:

10mg oral dose

Treatment:

Drug: GSK835726 (10mg)

GSK835726 (50mg)

Active Comparator group

Description:

50mg oral dose

Treatment:

Drug: GSK835726 (50mg)

GSK835726 (100mg)

Active Comparator group

Description:

50mg oral dose

Treatment:

Drug: GSK835726 (100mg)

Cetirizine 10mg

Active Comparator group

Description:

10mg cetirizine as active comparator

Treatment:

Drug: Cetirizine (10mg)

placebo

Placebo Comparator group

Description:

placebo tablet

Treatment:

Other: Placebo