A randomised, single-blind, cross-over study investigating the interactions between bronchoconstriction and cough in asthma

niversity Hospital of South Manchester0 个研究点目标入组 15 人开始时间: 2015年3月18日最近更新: 2017年11月27日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

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

•1. Aged =18
•2. Have taken part in Studying Cough in Asthma Phenotypes” (CoAst) study
•3. Person with a diagnosis of atopic asthma (based on a positive skin prick test)
•4. The subject is treated with:
•4.1. Short acting Beta 2 Agonist PRN AND/OR
•4.2. Inhaled corticosteroid (=250 mcg fluticasone propionate daily or equivalent)
•5. Controlled or has partial asthma control according to GINA classification

排除标准

•1. Subjects who have previously coughed less than a total of four coughs in one dose at the ED50 dose of capsaicin inhalation (assess after visit 1)
•2. Subjects who bronchoconstrict by more than 10% at the end of the full dose capsaicin cough challenge (assess after visit 1)
•3. Subjects who do not display evidence of airway hyper-responsiveness (PC20 >8 mg/ml) (assess after visit 2)
•4. Symptoms of upper respiratory tract infection (URTI) in the last 1 month which have not resolved
•5. Lower respiratory tract infection or pneumonia in the last 6 weeks
•6. Current smoker or ex-smoker with =10 pack-year smoking history and abstinence of =6 months
•7. Asthma exacerbation in the previous month requiring an increase or start of an ICS or OCS
•8. Asthma medication which include theophylline or anti-cholinergic drugs
•9. Subject has changed asthma medication within the past 4 weeks prior to screening
•10. A previous asthma exacerbation requiring Intensive Care Unit (ICU) admission
•11. Significant other primary pulmonary disorders, in particular: pulmonary embolism, pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis, emphysema or bronchiectasis
•12. Pregnancy or breastfeeding
•13. Use of ACE inhibitors
•14. Any centrally acting medication which in the view of the investigator could alter the sensitivity of the cough reflex*
•15. History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial
•*Any participant who is taking tricyclic anti-depressants, pregabalin, gabapentin or opioids will not be eligible to take part in this study unless they are willing and medically able to withdraw from such medication for the duration of the study. The reason for this is that centrally acting medications may alter the sensitivity of the cough reflex

研究者

发起方

niversity Hospital of South Manchester

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