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

Allergic Rhinitis Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824356
• Other study ID #: 110159
• Secondary ID: 723 PoC
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2009
• Last updated: June 18, 2009
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: June 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• GSK1004723 (200mg)
Intranasal antihistamine.

Other:
• Placebo
Equivalent to GSK1004723 in presentation etc.

Drug:
• GSK1004723 (1000mg)
Intranasal antihistamine.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total nasal symptom score 0-4 hours post dose		0-4 hours post dose