An 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR)

GlaxoSmithKline Research & Development Limited0 个研究点开始时间: 2008年1月3日最近更新: 2012年3月19日

适应症

试验速览

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•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

•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
•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.

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