EUCTR2008-005205-19-GB进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, 3-period cross-over study to evaluate the effect of two doses of GSK2190915 on the allergen-induced early asthmatic response in subjects with mild asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Males and females aged 18 to 55 years inclusive.
- •2. Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
- •3. Female subjects must be of non childbearing potential.
- •4. Male subjects must agree to use one of the contraception methods listed in
- •Section 8.1 of the protocol.
- •5. Documented history of bronchial asthma, first diagnosed at least 6 months prior
- •to the screening visit and currently being treated only with intermittent short-
- •acting beta -agonist therapy by inhalation.
- •6. Pre-bronchodilator FEV1 >70% of predicted at screening.
- •7. Subjects who are current non-smokers who have not used any tobacco products
- •in the 6-month period preceding the screening visit.
- •8. Demonstration of a positive wheal and flare reaction (> 3 mm relative to negative
- •control) to at least one allergen from a battery of allergens on skin prick testing.
- •9. Methacholine challenge PC20 < 8 mg/mL at screening or previous AMP, histamine
- •or methacholine challenge that confirms the diagnosis of asthma.
- •10. Screening allergen challenge demonstrates that the subject experiences an
- •early asthmatic response.
- •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. Past or present disease, which as judged by the investigator or medical monitor,
- •may affect the outcome of this study.
- •2. Clinically significant abnormalities in safety laboratory analysis at screening.
- •3. Subject has known history of hypertension or is hypertensive at screening.
- •4. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to
- •the first dose of study medication.
- •5. History of life-threatening asthma, defined as an asthma episode that required
- •intubation and/or was associated with hypercapnoea, respiratory arrest and/or
- •hypoxic seizures.
- •6. Symptomatic with hay fever at screening or predicted to have symptomatic
- •hayfever during the time of study.
- •7. Administration of oral or injectable steroids within 5 weeks of screening or
- •intranasal and/or inhaled steroids within 4 weeks of the screening visit.
- •8. Unable to abstain from other medications including non-steroidal anti-
- •inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-
- •asthma, anti-rhinitis or hay fever medication.
- •9. If, after 2 concurrent administrations of saline during the allergen challenge at
- •screening the subjects still have a fall in FEV1 of greater than 10%.
- •10.The subject has participated in a study with a new molecular entity during the
- •previous 3 months or has participated in 4 or more clinical studies in the previous
- •12 months prior to the first dosing day.
- •11.History of being unable to tolerate or complete methacholine and/or allergen
- •challenge tests.
- •12.The subject has a screening QTc value of >450msec, PR interval outside the
- •range 120 to 220msec or an ECG that is not suitable for QT measurements.
- •13.The subject has tested positive for hepatitis C antibody or hepatitis B surface
- •14.The subject has tested positive for HIV antibodies.
- •15.The subject has a positive pre-study urine cotinine/ breath carbon monoxide test
- •or urine drug or urine or breath alcohol screen.
研究者
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