EUCTR2005-005523-34-GB进行中（未招募）1 期
A PROOF OF CONCEPT STUDY TO EVALAUTE EFFECTS INTRANASAL SALMETEROL AND FLUTICASONE GIVEN ALONE AND IN COMBINATION IN ALLERGIC RHINITIS - Effects of Intranasal Salmeterol and Fluticasone in Allergic Rhinitis
niversity of Dundee (Research & Innovation Services)0 个研究点目标入组 30 人开始时间: 2006年3月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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.Persistent allergic rhinitis without asthma.
- •2.Atopy to at least 1 allergen on SPT.
- •3.= 20% drop in PNIF following nasal AMP challenge
- •4.Male to female aged 18-65
- •5.Informed Consent
- •6.Ability to comply with the protocol
- •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.Severe allergic rhinitis as defined by those in whom there are symptoms
- •which significantly impair day to day activities on QOL questionnaire.
- •2.Nasal Polyposis grade 2/3, deviated nasal septum = 50%
- •3.PNIF < 60 litres/min
- •4.The use of oral corticosteroids within the last 3 months.
- •5.Recent respiratory tract / sinus infection (2 months).
- •6.Significant concomitant respiratory disease such as COPD, CF, ABPA,
- •bronchiectasis and active pulmonary tuberculosis.
- •7.Any other clinically significant medical condition such as unstable angina,
- •acute myocardial infarction in the preceding 3 months, recent TIA/
- •CVA,that may endanger the health or safety of the participant, or
- •jeopardise the protocol.
- •8.Any significant abnormal laboratory result as deemed by the investigators
- •9.Pregnancy, planned pregnancy or lactation
- •10.Known or suspected contra-indication to any of the IMP’s
- •11.Concomitant use of medicines (prescribed, over the counter or herbal) that
- •may interfere with the trial.
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