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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00824356

Enrollment

Registered

2009-01-16

Start date

2008-06-30

Completion date

2008-08-31

Last updated

2009-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis, Proof-of-Concept

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

Interventions

DRUGGSK1004723 (200mg)

Intranasal antihistamine.

OTHERPlacebo

Equivalent to GSK1004723 in presentation etc.

DRUGGSK1004723 (1000mg)

Intranasal antihistamine.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in total nasal symptom score 0-4 hours post dose	0-4 hours post dose

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026