EUCTR2015-001736-38-GB进行中(未招募)1 期
The utility of feNO in the differential diagnosis of chronic cough: The response to anti-inflammatory therapy with prednisolone and montelukast - The utility of feNO in the differential diagnosis of chronic cough
Hull and East Yorkshire Hospitals NHS trust0 个研究点目标入组 50 人开始时间: 2015年9月18日最近更新:
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
- 50
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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- •Patients with a history of chronic cough (at least 8 weeks duration)
- •Male and female subjects of at least 18 yrs of age
- •Subjects able to understand the study and co-operate with the study procedures
- •Subjects who consent to their general practitioner (GP) being informed of their study participation.
- •Patients with a FeNO=30ppb at presentation to the Chronic cough clinic.( required for entry on to the high FeNO treatment groups)
- •Patients with FeNO=20 ppb at presentation to the chronic cough clinic (required for entry as a normal FeNO treatment group)
- •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 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with current diagnosis of asthma.
- •Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures
- •Suffering from any concomitant disease (chronic heart, chronic lung such as; COPD, bronchiectasis and cystic fibrosis, chronic renal, chronic liver or neuromuscular disease or immunosuppression; pneumonia and diabetes) which may interfere with study procedures or evaluation.
- •A lower respiratory tract infection 4 weeks prior to entry on to study
- •Systemic infections
- •Live virus immunisation planned within next 3 months
- •Subjects with no previous chickenpox who had a recent (<=28 days) close personal contact with chickenpox OR herpes zoster (high FeNO treatment groups only)
- •Subjects having recent (<=28 days) exposure to measles (high FeNO treatment groups only)
- •Participation in another study (use of investigational product) within 30 days preceding entry on to study.
- •Alcohol or drug abuse
- •Inability to follow study procedures
- •Regular use of corticosteroids either as inhaled, topical or systemic = 4 weeks prior to enrolment
- •. Subjects who are taking bronchodilators should be on it for at least 4 weeks on regular dose and carry on the same dose during the study
- •Subjects with known allergy to prednisolone
- •Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.
- •Current smoker
研究者
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