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

November 4, 2016 updated by: GlaxoSmithKline

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GSK835726 (10mg)
10mg oral dose
Drug: GSK835726 (10mg)
GSK835726 (10mg) tablet
Active Comparator: Cetirizine 10mg
10mg cetirizine as active comparator
Drug: Cetirizine (10mg)
Cetirizine (10mg) tablet as positive control
Active Comparator: GSK835726 (50mg)
50mg oral dose
Drug: GSK835726 (50mg)
GSK835726 (50mg) tablet
Active Comparator: GSK835726 (100mg)
50mg oral dose
Drug: GSK835726 (100mg)
GSK835726 (100mg) tablet
Placebo Comparator: placebo
placebo tablet
Other: Placebo
Placebo to match active

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: 110163
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: 110163
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 110163
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 110163
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 110163
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: 110163
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: 110163
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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