Trial With Allergic Rhinitis Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber

May 31, 2012 updated by: GlaxoSmithKline

An 8 Day, Randomised, Double Blinded, Placebo-controlled 2-way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Placebo in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)

This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber. GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in development by GSK for the treatment of allergic rhinitis, asthma and COPD.

Subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used.

This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.

12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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

  • Austria
      • Vienna, Austria, A-1150
        • 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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject is healthy.
  • They are aged 18 to 50 years inclusive.
  • Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
  • They have a history of seasonal allergic rhinitis
  • They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber,
  • They have a positive skin prick test for grass pollen at or within the 12 months preceding the screening visit.
  • They have a positive RAST for grass pollen at or within the 12 months preceding the screening visit.
  • They are current non-smokers who have not used any tobacco products in the 6 months preceding the screening visit
  • They must have a baseline FEV1>80% predicted and a baseline FEV1 (maximum recorded value)/ FVC (associated value)>70% predicted.

Exclusion Criteria:

  • Pregnant or nursing females.
  • Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
  • any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 2 weeks) or ongoing upper respiratory tract infection.
  • The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge
  • The subject has a history of drug or other allergy
  • The subject is concurrently participating in another clinical study in the past 3 months
  • A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening
  • A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
  • The subject has donated a unit of blood within the previous 3 months.

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
Time Frame: 1-4h post-dose period spent in the Vienna Challenge Chamber on Day 7
1-4h post-dose period spent in the Vienna Challenge Chamber on Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
Time Frame: 1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 2.
1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 2.

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

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

January 1, 2007

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 30, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPR107498

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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