ISRCTN34161400进行中（未招募）未知
The Role of Transient Receptor Potential (TRP) Channels in the Mechanisms Underlying Cough in Health and Disease
niversity Hospital of South Manchester0 个研究点目标入组 100 人开始时间: 2016年1月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All participants:
- •1. Aged 18 years and over
- •Healthy volunteers:
- •1. Normal spirometry
- •2. No current or past history of chronic cough or respiratory disease
- •3. Non-smokers or ex-smokers (>6months abstinence) with smoking history of = 10 pack years
- •1. Physician diagnosis of asthma
- •2. Evidence of airways hyper-responsiveness to methacholine (PC20<16mg/ml) or significant bronchodilator reversibility (>12% FEV1) within the last 2 years.
- •3. Non-smokers or ex-smoker (>6months abstinence) with a smoking history of = 20 pack years
- •4. The subjects treated with:
- •4.1. Short acting Beta 2 Agonist PRN
- •4.2. AND/OR inhaled corticosteroid (=250mcg fluticasone propionate daily or equivalent)
- •1. Physician diagnosis of COPD
- •2. Ex-smokers (> 6 months abstinence) with smoking history of = 20 pack years
- •3. Spirometry demonstrating airflow obstruction i.e. FEV1/FVC ratio <70%
- •Idiopathic Pulmonary Fibrosis
- •1. Diagnosis of idiopathic pulmonary fibrosis following review by a Multi-Disciplinary Team (MDT).
- •2. Non-smokers or ex-smoker (>6months abstinence) with a smoking history of =20 pack years
- •Refractory Chronic Cough
- •3. History of a dry/minimally productive cough for 12 months
- •4. Normal spirometry
- •5. No clinically significant findings to explain chronic cough on CXR or CT scan of thorax
- •6. Completed appropriate investigation and/or trials of treatment for common causes of chronic cough
- •7. Non-smokers or ex-smoker (>6months abstinence) with a smoking history of =20 pack years
排除标准
- •All participants:
- •1. Ex-smokers with <6 months abstinence
- •2. Upper respiratory tract infection within last 4 weeks
- •3. Exacerbation of respiratory disease in the last 4 weeks requiring additional medication.
- •4. A change in regular medication within the past 4 weeks prior to screening
- •5. Patients with severe respiratory disease e.g. FEV1 <1 litre, requirement of oxygen therapy
- •6. Use of ACE inhibitors
- •7. Use of centrally acting medications that may alter the cough reflex e.g. opiates, gabapentin, pregabalin, amitriptyline (unless they are willing and medically able to withdraw from such medication for the duration of the study and sought advice from their GP or clinician)
- •8. History of drug or alcohol abuse
- •9. Pregnancy or breastfeeding
- •10. Concomitant conditions which may alter cough responses e.g. diabetes mellitus with autonomic neuropathy, Parkinson’s disease, stroke.
- •11. Concomitant conditions which affect the subjects’ ability to participate in the study.
- •12. Uncontrolled hypertension (i.e., >165/95 mmHg despite adequate medical therapy).
- •13. Allergy or intolerance of salbutamol
- •1. Subjects treated with high dose inhaled corticosteroid (>250mcg fluticasone propionate daily or equivalent)
- •Idiopathic Pulmonary Fibrosis
- •1. High dose systemic steroids i.e. prednisolone >20mg daily or equivalent. Those patients on lower doses of steroids for >1 month may be included
- •2. Resting blood oxygen saturation of <90 %
- •3. Concurrent use of pirfenidone, unless receiving a stable dose for at least 4 weeks prior to screening
- •4. A history of concomitant asthma or obstructive airway disease, or those with an FEV1/FVC ratio at screening of <70%
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