Allergic Rhinitis Clinical Trial
Official title:
A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
Verified date | June 2009 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic
Status | Completed |
Enrollment | 54 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma. - Male - 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 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 |
Country | Name | City | State |
---|---|---|---|
Germany | GSK Investigational Site | Hannover | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in total nasal symptom score 0-4 hours post dose | 0-4 hours post dose |
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