Seasonal Allergic Rhinitis MedDRA version: 8.1 Level: LLT Classification code 10039776
Conditions
Interventions
Product Name: GSK256066B Aqueous Nasal Spray
Product Code: GSK256066B
Pharmaceutical Form: Nasal spray, suspension
Current Sponsor code: GSK256066B
Concentration unit: µg microgram(s)
Concentration ty
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is healthy. 2. They are aged 18 to 50 years inclusive. 3. Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive. 4. They have a history of seasonal allergic rhinitis. 5. They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber, which is defined as a nasal symptom score of at least 6. 6. They have a positive skin prick test (wheal >/= 4mm) for grass pollen at or within the 12 months preceding the screening visit. 7. They have a positive RAST (>/= class 2) for grass pollen at or within the 12 months preceding the screening visit. 8. They are current non-smokers who have not used any tobacco products in the 6 months preceding the screening visit with a pack history of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing females. 2. Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception from at least two weeks prior to the first dose of study medication; and to continue until the final pregnancy test has been performed. 3. On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent or ongoing upper respiratory tract infection. 4. Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function. 5. The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge. 6. The subject has a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. 7. The subject has a screening QTc value of >430msec (>450msec for females), PR interval outside the range 120 to 240msec or an ECG that is not suitable for QT measurements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate effect of repeat intranasal doses of GSK256066 vs. placebo on nasal symptoms of allergic rhinitis provoked by spending 6h in the Vienna Challenge Chamber after dosing on Day 14;Secondary Objective: • Explore effects of repeat doses GSK256066 vs. placebo on nasal, eye and global symptoms, nasal obstruction and secretions in allergic rhinitis • Establish effect of repeat intranasal doses of GSK256066 vs. placebo on late phase inflammatory markers in allergic rhinitis • Establish effect of repeat intranasal doses of GSK256066 vs. placebo on nasal, eye and global symptoms, nasal obstruction and secretions in allergic rhinitis at 22 – 26h post-dose, as a measure of duration of action • To explore the effects of GSK256066 on novel cellular markers and secreted markers of PDE4 inhibition in nasal lavage and scrape samples in mild to moderate allergic rhinitic subjects;Primary end point(s): Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction) 0-6h post-dose period spent in the Vienna Challenge Chamber on Day 14 | — |
Countries
Austria
Outcome results
None listed