EUCTR2015-002555-10-GB进行中（未招募）1 期
Effect of the CRTH2 antagonist OC459 on the response to rhinovirus challenge in asthma - Effect of OC459 on the response to rhinovirus challenge in asthma
Imperial College0 个研究点目标入组 44 人开始时间: 2015年9月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
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
入选标准
- •Age 18-55 years
- •Male or female
- •Clinical diagnosis of asthma for at least 6 months prior to screening
- •An Asthma Control Questionnaire (ACQ) Score >0.75
- •Positive histamine challenge test (PC20 <8 µg/ml, or <12 µg/ml and bronchodilator response = 12%)
- •Worsening asthma symptoms with infection since last change in asthma therapy
- •Positive skin prick test to common aeroallergens (e.g. animal epithelia, dust mite)
- •Treatment comprising inhaled corticosteroids (ICS) or combination inhaler (Long-Acting Beta Agonist with ICS), with a daily ICS dose of at least 100mcg fluticasone or equivalent.
- •Participant is willing for their GP to be informed of their participation.
- •English speaker
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Presence of clinically significant diseases other than asthma (cardiovascular, renal, hepatic, gastrointestinal, haematological, pulmonary, neurological, genitourinary, autoimmune, endocrine, metabolic, neoplasia etc.), which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient’s ability to take part in it
- •Smoking history over past 12 months.
- •Seasonal allergic rhinitis symptoms at screening or during the 3 week run-in (prior to rhinovirus inoculation).
- •Asthma exacerbation or viral illness within the previous 6 weeks or during the 3 week run-in (prior to rhinovirus inoculation).
- •Current or concomitant use of oral steroids, anti-leukotrienes or monoclonal antibodies.
- •Pregnant or breast-feeding women. Patients should not be enrolled if they plan to become pregnant during the time of study participation (see note regarding contraception below).
- •Contact with infants <6 months or immunocompromised persons, elderly and infirm at home or at work.
- •Subjects who have known evidence of lack of adherence to medications and/or ability to follow physician’s recommendations.
研究者
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Effect of OC459 on the Response to Rhinovirus Challenge in AsthmaRhinovirusPicornaviridae InfectionsAsthmaCommon ColdNCT02660489Imperial College London44
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