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临床试验/EUCTR2015-001736-38-GB
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:
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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

发起方
Hull and East Yorkshire Hospitals NHS trust

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