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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GSK1004726 (1000mg)

1000mg aqueous suspension

Group Type ACTIVE_COMPARATOR

GSK1004723 (1000mg)

Intervention Type DRUG

Intranasal antihistamine.

Placebo

Intranasal spray

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Equivalent to GSK1004723 in presentation etc.

GSK1004723 (1000mg)

Intervention Type DRUG

Intranasal antihistamine.

GSK1004723 (200mg)

200 mg aqueous suspension

Group Type ACTIVE_COMPARATOR

GSK1004723 (200mg)

Intervention Type DRUG

Intranasal antihistamine.

Interventions

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GSK1004723 (200mg)

Intranasal antihistamine.

Intervention Type DRUG

Placebo

Equivalent to GSK1004723 in presentation etc.

Intervention Type OTHER

GSK1004723 (1000mg)

Intranasal antihistamine.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No