Status:
COMPLETED
723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis, Allergic, Seasonal
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (...
Eligibility Criteria
Inclusion
- Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- Males or female using contraceptives
- Aged 18 - 65
- Weight 50kg+, BMI 19-32 kg/m2
- Exhibit response to Challenge Chamber and skin prick test.
- Non-smoker
- Capable of giving informed consent
- AST and ALT\<2xULN; alkaline phosphatase and bilirubin \<or=1.5xULN
Exclusion
- 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
- Pregnant or llactating females
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00972504
Start Date
June 1 2009
End Date
August 14 2009
Last Update
August 2 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Hanover, Lower Saxony, Germany, 30625