Seasonal allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is healthy. 2. They 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. 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 = 10 pack years. 9. They must have a baseline FEV1>80% predicted and a baseline FEV1 (maximum recorded value)/FVC (maximum recorded value)>70% predicted. 10. They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form. 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. 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 screening QTc(B) value >450msec, PQ interval outside the range 120 to 240msec or an ECG that is not suitable for QT measurements. In addition subjects will be excluded if they have a history of atrial and ventricular arrhythmia. 7. A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening. 8. A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening. 9. The subject had used oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate effect of repeat intranasal doses of fluticasone propionate alone vs. GSK256066 + fluticasone propionate on nasal symptoms of allergic rhinitis;Secondary Objective: Explore effects of repeat intranasal doses of fluticasone propionate alone vs. GSK256066 + fluticasone propionate and GSK256066 alone vs. GSK256066 + fluticasone propionate on eye and global symptoms, nasal obstruction and secretions in allergic rhinitis Explore the safety and tolerability of repeat intranasal doses of GSK256066 and GSK256066 in combination with fluticasone propionate in mild to moderate allergic rhinitic subjects Explore the effects of GSK256066 and fluticasone propionate on exploratory markers of PDE4 inhibition and glucocorticoid-provoked gene expression, respectively, in nasal lavage and scrape samples in mild to moderate allergic rhinitic subjects;Primary end point(s): Weighted mean TNSS (sneeze, itch, rhinorrhoea and obstruction) 1 to 4 hours post morning dose period spent in the Vienna Challenge Chamber on Day 2 | — |
Countries
Austria
Outcome results
None listed