Pharmacological modulation of the urge to cough: the effects of morphine sulphate

niversity Hospital of South Manchester NHS Foundation Trust0 个研究点目标入组 60 人开始时间: 2015年5月6日最近更新: 2018年6月11日

适应症

试验速览

暂无简介。

•Phase 1 (healthy volunteers):
•1. Healthy male or female aged over 18 years
•2. Nonsmoker
•3. Normal spirometry
•4. No history of asthma
•Phase 2 (chronic cough patients):
•1. Male or female age over 18 years
•2. Diagnosed with idiopathic chronic cough (greater than 8 weeks duration)
•3. Normal spirometry
•4. Treated with low dose (5 to 10 mg) Morphine Sulphate twice daily and willing to temporarily withdraw morphine treatment for study purposes

•Phase 1 (healthy volunteers):
•1. Male or female <18 years old
•2. Current smoker
•3. History of asthma or other chronic respiratory disease
•Phase 2 (chronic cough patients):
•1. Current use of medications potentially modifying cough reflex sensitivity e.g. Amitriptyline, Pregabalin, Codeine, etc
•2. History of medical conditions potentially modifying cough reflex sensitivity e.g. Diabetes Mellitus with autonomic neuropathy, neurological conditions e.g. cerebrovascular disease, Parkinson’s disease etc
•3. Recent upper respiratory tract infection (<4 weeks)
•4. Pregnancy/breastfeeding. Women of childbearing potential (not >2 years postmenopausal and/or not surgically sterilised) must have a negative urine pregnancy test, performed at visit 1 prior to administration of study medication
•5. Current smokers or exsmokers with <6 months abstinence or cumulative history of >10 pack years
•6. Current treatment with ACE inhibitors
•7. Drug or alcohol abuse
•8. Uncontrolled hypertension (i.e., >160/90 mmHg despite adequate medical therapy)
•9. Recent myocardial infarction, or history of congestive cardiac failure
•10. Any clinically significant neurological disorder
•11. Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient’s ability to participate in the study

发起方

niversity Hospital of South Manchester NHS Foundation Trust