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Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo

NCT ID: NCT00851344

Last Updated: 2016-11-07

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

2008-09-30

Study Completion Date

2008-11-30

Brief Summary

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A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis

Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal

Keywords

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Proof-of-Concept 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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GSK835726 (10mg)

10mg oral dose

Group Type ACTIVE_COMPARATOR

GSK835726 (10mg)

Intervention Type DRUG

GSK835726 (10mg) tablet

GSK835726 (50mg)

50mg oral dose

Group Type ACTIVE_COMPARATOR

GSK835726 (50mg)

Intervention Type DRUG

GSK835726 (50mg) tablet

GSK835726 (100mg)

50mg oral dose

Group Type ACTIVE_COMPARATOR

GSK835726 (100mg)

Intervention Type DRUG

GSK835726 (100mg) tablet

Cetirizine 10mg

10mg cetirizine as active comparator

Group Type ACTIVE_COMPARATOR

Cetirizine (10mg)

Intervention Type DRUG

Cetirizine (10mg) tablet as positive control

placebo

placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo to match active

Interventions

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GSK835726 (10mg)

GSK835726 (10mg) tablet

Intervention Type DRUG

GSK835726 (50mg)

GSK835726 (50mg) tablet

Intervention Type DRUG

GSK835726 (100mg)

GSK835726 (100mg) tablet

Intervention Type DRUG

Cetirizine (10mg)

Cetirizine (10mg) tablet as positive control

Intervention Type DRUG

Placebo

Placebo to match active

Intervention Type OTHER

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 - 60
* 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

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

Countries

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Germany

References

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Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H(1)/H(3) receptor antagonists in seasonal allergic rhinitis. Int Arch Allergy Immunol. 2012;158(1):84-98. doi: 10.1159/000329738. Epub 2011 Dec 29.

Reference Type BACKGROUND
PMID: 22212854 (View on PubMed)

Study Documents

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Document Type: Annotated Case Report Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Document Type: Dataset Specification

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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110163

Identifier Type: -

Identifier Source: org_study_id