Intranasal midazolam for the palliation of dyspnoea in patients with optimally treated life limiting disease

Arohanui Hospice Service Trust, Clare Randall as representative0 个研究点目标入组 200 人开始时间: 2009年6月25日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Participants must:
•be at least 18 years of age
•have dyspnoea related to life-limiting disease or its treatment
•have a dyspnoea score >3/10 on at least 3 occasions during the previous week
•be English speaking or have an interpreter available
•have an adequate performance status Australian Karnofsky Performance Scale (AKPS >30)
•be able to operate a nasal spray device
•be able to understand all trial requirements and complete a dyspnoea diary
•have had no changes in any medication likely to affect dyspnoea (eg steroids, opioids) within 48 hours of starting the study

•Patients will be excluded in the case of:
•an acute respiratory event likely to resolve eg. chest infection, acute exacerbation of asthma
•concurrent treatment with an unstable dose of benzodiazepines (excluding nocturnal sedation)
•concurrent treatment with an unstable dose of opioids (change in baseline dose within 48 hours of study entry or during the duration of the study)
•regular use (greater than 3 times/day) of breakthrough opioids for pain or dyspnoea that would interfere with assessment of benefit of the midazolam spray
•a previous adverse reaction to benzodiazepines
•concurrent treatment with itraconazole or ketoconazole
•respiratory depression (resting respiratory rate (RR) <10 breaths/minute)
•co-morbid myasthenia gravis, or acute narrow angle glaucoma
•an alcohol and/or drug dependency problem
•any intervention or change in therapy likely to effect dyspnoea during the study period or in the 2 weeks prior (this includes radiotherapy to the lung and/or chemotherapy or blood transfusion 72 hours prior with the potential to effect dyspnoea )
•any change in oxygen prescription during the study period

发起方

Arohanui Hospice Service Trust, Clare Randall as representative