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

Primary Purpose

Rhinitis, Allergic, Seasonal

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

GSK835726 (10mg)

GSK835726 (50mg)

GSK835726 (100mg)

Cetirizine (10mg)

Placebo

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Proof-of-Concept, Allergic Rhinitis

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Arm Label

GSK835726 (10mg)

GSK835726 (50mg)

GSK835726 (100mg)

Cetirizine 10mg

placebo

Arm Description

10mg oral dose

50mg oral dose

10mg cetirizine as active comparator

placebo tablet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00851344

First Posted

February 24, 2009

Last Updated

November 4, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00851344

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Allergic, Seasonal

Keywords

Proof-of-Concept, Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK835726 (10mg)

Arm Type

Active Comparator

Arm Description

10mg oral dose

Arm Title

GSK835726 (50mg)

Arm Type

Active Comparator

Arm Description

50mg oral dose

Arm Title

GSK835726 (100mg)

Arm Type

Active Comparator

Arm Description

50mg oral dose

Arm Title

Cetirizine 10mg

Arm Type

Active Comparator

Arm Description

10mg cetirizine as active comparator

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo tablet

Intervention Type

Drug

Intervention Name(s)

GSK835726 (10mg)

Intervention Description

GSK835726 (10mg) tablet

Intervention Type

Drug

Intervention Name(s)

GSK835726 (50mg)

Intervention Description

GSK835726 (50mg) tablet

Intervention Type

Drug

Intervention Name(s)

GSK835726 (100mg)

Intervention Description

GSK835726 (100mg) tablet

Intervention Type

Drug

Intervention Name(s)

Cetirizine (10mg)

Intervention Description

Cetirizine (10mg) tablet as positive control

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo to match active

Primary Outcome Measure Information:

Title

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

Time Frame

0-4 hours post dose

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

22212854

Citation

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.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110163

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110163

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110163

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110163

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110163

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110163

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110163

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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