Seasonal allergic rhinitis MedDRA version: 8.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Interventions
Product Name: GSK256066B Aqueous Nasal Spray
Product Code: GSK256066B
Pharmaceutical Form: Nasal spray, suspension
Current Sponsor code: GSK256066
Concentration unit: µg microgram(s)
Concentration typ
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 for grass pollen at or within the 12 months preceding the screening visit. 7. They have a positive RAST 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 80% predicted and a baseline FEV1(maximum recorded value)/FVC(maximum recorded value)>70% predicted. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=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 (within 3 weeks) 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 participated in a study with a new molecular entity during the previous 4 months or in any clinical study in the previous 3 months. 7. The subject has a screening QTc value >450msec, PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements. In addition subjects will be excluded if they have a history of atrial or ventricular arrhythmia. 8. A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening. 9. A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening. 10. Subjects with abnormal creatinine clearance values at screening.
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 Environmental Chamber Allergen Challenge (ECC) after morning dosing on Day 7;Secondary Objective: • Investigate effect of GSK256066 on nasal symptoms provoked by ECC on Day 2 • Explore effects of GSK256066 on eye and global symptoms, nasal obstruction and secretions in allergic rhinitis provoked by ECC on day 2 and 7 • Establish effect of GSK256066 on nasal, eye and global symptoms, nasal obstruction and secretions provoked by ECC on day 8 • Explore the safety and tolerability of repeat doses of GSK256066 in mild to moderate allergic rhinitic subjects • To explore the effects of GSK256066 on novel markers of PDE4 inhibition in nasal lavage and scrape samples ;Primary end point(s): Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction) 1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 7 | — |
Countries
Austria
Outcome results
None listed