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

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: GSK1004723 (1000mg); Other: Placebo; Drug: GSK1004723 (200mg)

• Registration Number: NCT00824356
• Lead Sponsor: GlaxoSmithKline

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-18
• Last Update Posted: 2009-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GSK1004726 (1000mg)	GSK1004723 (1000mg)	1000mg aqueous suspension
Placebo	Placebo	Intranasal spray
Placebo	GSK1004723 (1000mg)	Intranasal spray
GSK1004723 (200mg)	GSK1004723 (200mg)	200 mg aqueous suspension

Primary Outcome Measures

Name	Time	Method
Change from baseline in total nasal symptom score 0-4 hours post dose	0-4 hours post dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Hannover, Niedersachsen, Germany