Status:
COMPLETED
Trial With Allergic Rhinitis Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis, Allergic, Seasonal
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 po...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00430157
Start Date
January 1 2007
Last Update
June 4 2012
Active Locations (1)
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1
GSK Investigational Site
Vienna, Austria, A-1150