The effects of morphine on breathlessness and sleep in chronic obstructive pulmonary disease: A randomised, double-blind, placebo controlled cross-over study

Adelaide Institute for Sleep Health, Flinders University0 个研究点目标入组 22 人开始时间: 2021年6月15日最近更新: 2022年6月6日

适应症

试验速览

暂无简介。

•Aged 18 years and older
•-Chronic Obstructive Pulmonary Disease (COPD)
•-Chronic breathlessness syndrome (as defined as a modified Medical Research Council breathlessness score of 2 or more)
•-Optimal pharmacological treatment based on Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) 2021 Report
•-An Australia-modified Karnofsky Performance Status (AKPS) scale score greater than or equal to 40

•-Concurrent use of opioids, benzodiazepines, or monoamine-oxidase inhibitors, or within 7 days of such therapy
•-Body mass index >40kg/m2
•-Prior diagnosis of severe obstructive sleep apnea (apnea-hypopnea index more than 30 events/hr)
•-Uncontrolled nausea, vomiting, or gastrointestinal obstruction
•-Calculated creatinine clearance <25mL/min
•-Two or more hepatic enzyme greater than or equal to 3 times the upper limit of normal
•-International normalised ratio >1.2 in the absence of warfarin
•-Unresolved cardiac or respiratory event in the past 7 days (excluding upper respiratory tract infections)
•-Anaemia for which a blood transfusion was indicated for breathlessness in the past 12 months
•-Pregnant, or childbearing potential not using contraception
•-Breastfeeding
•-Waiting list for lung transplantation
•-Change in COPD medications in the past 7 days (except as needed medications)
•-Use of home non-invasive ventilation (NIV)
•-History of endotracheal intubation for respiratory failure
•-History of severe COPD exacerbation requiring acute NIV
•-History of opioid-related respiratory failure
•-History of opioid dependence (as per the International Classification of Diseases and Health Problems (ICD-10) definition)
•-Any condition that in the investigator’s opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation

发起方

Adelaide Institute for Sleep Health, Flinders University