Back to results

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

Primary Purpose

Rhinitis, Allergic, Seasonal, Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

GSK256066

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Vienna Challenge Chamber, Seasonal Allergic Rhinitis, Inflammation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

GSK Investigational Site

Outcomes

Primary Outcome Measures

Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)

Secondary Outcome Measures

Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)

Full Information

NCT ID

NCT00430157

First Posted

January 30, 2007

Last Updated

May 31, 2012

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00430157

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Rhinitis, Allergic, Seasonal, Seasonal Allergic Rhinitis

Keywords

Vienna Challenge Chamber, Seasonal Allergic Rhinitis, Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

GSK256066

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

Vienna

ZIP/Postal Code

A-1150

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs