723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-01

Study Completion Date

2009-08-14

Brief Summary

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This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.

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Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GSK835726 (10mg)

10mg oral dose

Group Type ACTIVE_COMPARATOR

GSK835726 10mg

Intervention Type DRUG

GSK835726 10mg tablet

GSK1004723 (1000mcg)

1000mcg nasal spray solution

Group Type ACTIVE_COMPARATOR

GSK1004723 1000mcg

Intervention Type DRUG

GSK1004723 1000mcg nasal spray solution

Cetirizine 10mg

10mg cetirizine as active comparator

Group Type ACTIVE_COMPARATOR

Cetirizine 10mg

Intervention Type DRUG

Cetirizine 10mg active comparator

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo to match actives

Interventions

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GSK835726 10mg

GSK835726 10mg tablet

Intervention Type DRUG

GSK1004723 1000mcg

GSK1004723 1000mcg nasal spray solution

Intervention Type DRUG

Cetirizine 10mg

Cetirizine 10mg active comparator

Intervention Type DRUG

placebo

placebo to match actives

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.
* Males or female using contraceptives
* 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
* AST and ALT\<2xULN; alkaline phosphatase and bilirubin \<or=1.5xULN

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
* Pregnant or llactating females
* 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

ALL

Accepts Healthy Volunteers

No

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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