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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Other: Placebo; Drug: GSK1004723 (1000mg); Drug: GSK1004723 (200mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824356

723 PoC

110159

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: Male

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.
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

54 participants in 3 patient groups, including a placebo group

GSK1004726 (1000mg)

Active Comparator group

Description:

1000mg aqueous suspension

Treatment:

Drug: GSK1004723 (1000mg)

Placebo

Placebo Comparator group

Description:

Intranasal spray

Treatment:

Drug: GSK1004723 (1000mg)

Other: Placebo

GSK1004723 (200mg)

Active Comparator group

Description:

200 mg aqueous suspension

Treatment:

Drug: GSK1004723 (200mg)