EUCTR2007-005302-44-AT进行中（未招募）不适用
A randomised, double blind, 2-way crossover trial of 8 days repeat dosing with intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. The subject is healthy.
- •2. Male or female between 18 and 50 years inclusive.
- •3. A female subject is eligible to participate if she is of:
- •Non-childbearing potential defined as pre-menopausal females with a
- •documented tubal ligation or hysterectomy; or postmenopausal defined as 12
- •months of spontaneous amenorrhea.
- •Child-bearing potential and agrees to use one of the contraception methods
- •listed in Section 8.1 for an appropriate period of time (as determined by the
- •product label or investigator) prior to the start of dosing to sufficiently minimize
- •the risk of pregnancy at that point. Female subjects must agree to use
- •contraception until the end of the study.
- •4. Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females
- •50kg) to 95.0kg inclusive.
- •5. The subject has a history of seasonal allergic rhinitis.
- •6. The subject exhibits a moderate response to 1500 grass pollen grains/m3 after 2
- •hours in the Vienna Challenge Chamber, defined as a nasal symptom score of at
- •7. The subject has a positive skin prick test (wheal = 4mm) for grass pollen at or
- •within the 12 months preceding the screening visit.
- •8. The subject has a positive RAST (= class 2) for grass pollen at or within the 12
- •months preceding the screening visit.
- •9. The subject is a current non-smoker who has not used any tobacco products in
- •the 6 months preceding the screening visit with a pack history of = 10 pack years.
- •10. The subject must have a baseline FEV1>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
排除标准
- •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 has donated a unit of blood (450mL) within the previous 3 months or
- •intends to donate within 3 months of completing the study.
- •10. The subject has used oral, injectable or dermal steroids within 5 weeks or
- •intranasal and/or inhaled steroids within 1 week of the screening visit.
- •11. The subject has an elevated Troponin T above the normal range.
- •20. The subject, as deemed by the Investigator has a clinically significant CK-MB
- •value above the normal range.
研究者
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